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Randomized, blinded, No-Treatment control, multi-center, prospective clinical study, to identify whether TEOSYAL RHA® Redensity is more effective than No-Treatment in the correction of moderate to severe dynamic perioral rhytids at Week 8 after last treatment (i.e., initial or touch-up treatment).
The Treating Investigator (TI) at screening will evaluate the subject's perioral rhytids severity using the Perioral Rhytids Severity Rating Scale (PR-SRS) for eligibility of the subject for the study.
The Blinded Live Evaluator (BLE) at screening will evaluate the subject's perioral rhytids severity using the PR-SRS in order to confirm eligibility and to establish a pre-treatment (Baseline) score for assessment of effectiveness.
This is done independently of the TI, and exact concordance between the BLE and the TI is not necessary for eligibility of the subject in this study.
Enrolled subjects will be randomized to either the TEOSYAL RHA® Redensity treatment group or the "No-Treatment" control group (ratio 3:1).
The TI will administrate the study device, and if necessary, subjects will receive a touch-up treatment 14 days following the initial treatment to optimize the results.
The TI will conduct safety and effectiveness evaluations at study visits, which occurred at Week 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.
The Blinded Live Evaluator (BLE) will conduct assessments of effectiveness during the trial, including assessment of the primary endpoint at Week 8 after the last treatment (i.e., initial or touch-up treatment). The BLE will conduct effectiveness evaluations at Week 8, 12, 16, 24, 36, and 52 after the last treatment (i.e., initial or touch-up treatment).
All subjects will be followed for 52 weeks after the last treatment (i.e., initial treatment or touch-up), at which point they will be offered Repeat-Treatment (provided that the TI deems the treatment to be appropriate and the subject agrees) and will be then followed for 4 weeks after Repeat-Treatment before exiting the study.
If a subject returns to his pre-treatment PR-SRS score at Week 12 or Week 16 or Week 24 or Week 36 after initial treatment or touch up (as assessed by the TI), subjects are eligible for optional Early-Retreatment if necessary at 12 or 16 or 24 or 36 weeks after last treatment (provided that the TI deems the treatment appropriate, and the subject agrees).
Subjects will be then followed for an additional 4 weeks after Repeat-Treatment.
Subjects who will receive optional Early-Retreatment at Week 12 or Week 16 or Week 24 or Week 36 after the after initial treatment or touch-up, will be offered Repeat-Treatment at Week 52.
Subjects randomized to the "No-Treatment" control group will receive their first treatment after the primary endpoint evaluation (Week 8 after randomization) and then will be followed the same schedule as the initial treatment group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEOSYAL RHA Redensity | Experimental | Injection of TEOSYAL RHA Redensity into the perioral lines (n=150). Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks. |
|
| No Treatment | No Intervention | No treatment control group (n=52). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Device | A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 8 - Baseline score). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this primary outcome measure. | Week 8 after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. | The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely'). To calculate the FACE-Q score, outcomes from all 6 questions were pooled, data were transformed so that higher scores reflected a superior outcome and adapted to a 100- unit scale. The No-Treatment control group after treatment was not pooled for this secondary outcome measure. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 4 - Baseline score) and (Week 8 - Baseline score). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. |
Inclusion Criteria :
Exclusion Criteria :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34608092 | Derived | Sundaram H, Shamban A, Schlessinger J, Kaufman-Janette J, Joseph JH, Lupin M, Draelos Z, Carey W, Smith S, Eaton L. Efficacy and Safety of a New Resilient Hyaluronic Acid Filler in the Correction of Moderate-to-Severe Dynamic Perioral Rhytides: A 52-Week Prospective, Multicenter, Controlled, Randomized, Evaluator-Blinded Study. Dermatol Surg. 2022 Jan 1;48(1):87-93. doi: 10.1097/DSS.0000000000003238. |
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A total of 202 subjects were randomized with 150 subjects allocated to TEOSYAL RHA® Redensity and 52 subjects allocated to No-Treatment control.
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| ID | Title | Description |
|---|---|---|
| FG000 | TEOSYAL RHA Redensity | Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles. |
| FG001 | No Treatment | No treatment control group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
One subject randomized to No-Treatment control group (n initial =52) received, due to site error, injections with TEOSYAL RHA Redensity. This subject was only included in the SAFT population and censored of the effectiveness analysis. This resulted in an ITT population of 201 subjects (TEOSYAL RHA Redensity n=150, and no Treatment control n=51).
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| ID | Title | Description |
|---|---|---|
| BG000 | TEOSYAL RHA Redensity | Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 8 - Baseline score). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this primary outcome measure. | The Intent-to-Treat Population was used for this analysis. The ITT Population consisted of all subjects randomized in the TEOSYAL RHA® Redensity group and all subjects randomized in the No-Treatment control group (with the notable exception of 1 subject who received treatment with study device at Visit 1 and was censored from the ITT). | Posted | Count of Participants | Participants | Week 8 after last treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SAFT Population After Initial Treatment - V1/V1B to V9 | The SAFT Population consisted of all subjects who were randomized and received at least one treatment with the study device during the course of the study (i.e. all subjects in the No-Treatment control group and all subjects in the TEOSYAL RHA® Redensity treatment group). Of the 202 randomized subjects, 2 subjects did not receive any treatment during the whole study, resulting in a SAFT population of n=200. For this pooled analysis, only AEs onset on or after initial study treatment are included : from V1/V1B to V9 (W52 or 56 weeks for patients receiving a re-treatment at W52). Therefore, for No-Treatment group, all AEs with onset date before initial treatment, i.e. V1b date, are excluded from this summary table. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Cancer | Reproductive system and breast disorders | Systematic Assessment | unrelated to the study device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharitis | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Teoxane SA | +41(0) 22 344 96 36 | m.chenet@teoxane.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 27, 2017 | Apr 26, 2021 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2017 | Apr 26, 2021 | SAP_003.pdf |
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|
| Baseline, Weeks 4 and 8 after last treatment |
| Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the pre-injection baseline photograph. The No-Treatment control group after treatment was not pooled for this secondary outcome measure. | Weeks 4 and 8 after last treatment |
| Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the pre-injection baseline photograph. The No-Treatment control group after treatment was not pooled for this secondary outcome measure. | Week 8 after last treatment |
| Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment. | The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied). The No-Treatment control group after treatment was not pooled for this secondary outcome measure. | Week 8 after last treatment |
| Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity. | The Treating Investigator will assess adverse events and record details of seriousness, severity, duration, and action taken with the study device, and relationship to the study device. AEs will be reported from the time of consent until week 52 or to 1 month following the last treatment. | Baseline through Week 52 following the last treatment and 4 weeks following re-treatment |
| Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | The subjects will receive a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after treatment. The diary will be discussed during telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm). The subject diary captures the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and "other". The 14-day patient CTR diary includes a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate "other" if the subject experienced a sign/symptom that is not listed. The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR). | During 14 days after initial treatment and touch-up (2 weeks) |
| Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | The Injection Site Pain (during injection and post-injection) will be self-assessed by the subject using a 100 mm Visual Analog Scale (VAS). VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain. | Baseline, Weeks 2, 12, 16, 24, 36 and 52 |
| Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment. | Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment. |
| Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment. | Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment. |
| Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment. Lip sensation | Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment. |
| Weeks 4 and 8 after last treatment |
| Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the pre-injection baseline photograph. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. | Weeks 4 and 8 after last treatment |
| Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. Change = (Week 8 - Baseline score). | Week 8 after last treatment |
| Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score) and (Week 8 - Baseline score) | Weeks 4 and 8 after last treatment |
| Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. | Weeks 8, 12, 16, 24, 36 and 52 after last treatment |
| Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score), (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment |
| Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). For a given subject to be considered a responder, at least 2 of the 3 readers must have confirmed a 1-point improvement for that subject The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) | Weeks 8, 12, 16, 24, 36 and 52 after last treatment |
| Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) | Weeks 8, 12, 16, 24, 36 and 52 after last treatment |
| Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score), (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment |
| Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely'). To calculate the FACE-Q (Perioral Rhytids Domain) score, outcomes from all 6 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment |
| Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment |
| Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment. |
| Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. | Weeks 8, 12, 16, 24, 36 and 52 after last treatment |
| Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied). The No-Treatment control group after treatment was pooled for this exploratory outcome measure. | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment |
| Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | The natural look and feel of the perioral area was assessed by subjects using an 11-point scale (ranging from 0 to 10). The No-Treatment control group after treatment was pooled for this exploratory outcome measure. | Weeks 8, 12, 16, 24, 36 and 52 after last treatment |
| Santa Monica |
| California |
| United States |
| Coral Gables | Florida | United States |
| Omaha | Nebraska | United States |
| High Point | North Carolina | United States |
| Fairfax | Virginia | United States |
| Montreal | Canada |
| Victoria | Canada |
| BG001 | No Treatment | No treatment control group |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fitzpatrick Skin Type | The Fitzpatrick scale is a numerical classification schema for human skin color. Type I - always burns, never tans (pale white; blond or red hair; blue eyes; freckles). Type II - usually burns, tans minimally (white; fair; blond or red hair; blue, green, or hazel eyes) Type III - sometimes mild burn, tans uniformly (cream white; fair with any hair or eye color) Type IV - burns minimally, always tans well (moderate brown) Type V - very rarely burns, tans very easily (dark brown) Type VI - Never burns, never tans (deeply pigmented dark brown to darkest brown) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Smoking History | This demographic variable only count the population with a smoking history. 143 from 150 participants have a smoking history in the RHA Redensity (7 missing values). 50 from 51 participants have a smoking history in the no-treatment group (1 missing value). | Count of Participants | Participants |
|
| Sun Exposure | 143 from 150 participants have a Sun exposure in the RHA Redensity (7 missing values). 50 from 51 participants have a Sun exposure in the no-treatment group (1 missing values). | Count of Participants | Participants |
|
| Alcohol History | 143 from 150 participants have an alcohol history in the RHA Redensity (7 missing values). 50 from 51 participants have an alcohol history in the no-treatment group (1 missing values). | Count of Participants | Participants |
|
Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL). TEOSYAL RHA Redensity: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles. |
| OG001 | No Treatment | No treatment control group. |
|
|
|
| Secondary | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. | The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely'). To calculate the FACE-Q score, outcomes from all 6 questions were pooled, data were transformed so that higher scores reflected a superior outcome and adapted to a 100- unit scale. The No-Treatment control group after treatment was not pooled for this secondary outcome measure. | The Intent-to-Treat Population (n=150 for the TEOSYAL RHA Redensity group and n=51 for the No treatment group) was used for this analysis. Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 4 and 8 after last treatment |
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|
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| Secondary | Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the pre-injection baseline photograph. The No-Treatment control group after treatment was not pooled for this secondary outcome measure. | The Intent-to-Treat Population (n=150 for the Teosyal RHA Redensity group and n=51 for the No treatment group) was used for this analysis. Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available. | Posted | Count of Participants | Participants | Weeks 4 and 8 after last treatment |
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| Secondary | Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the pre-injection baseline photograph. The No-Treatment control group after treatment was not pooled for this secondary outcome measure. | The Intent-to-Treat Population (n=150 for the Teosyal RHA Redensity group and n=51 for the No treatment group) was used for this analysis. Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available. | Posted | Count of Participants | Participants | Week 8 after last treatment |
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|
|
| Secondary | Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment. | The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied). The No-Treatment control group after treatment was not pooled for this secondary outcome measure. | The Intent-to-Treat Population (n=150 for the Teosyal RHA Redensity group and n=51 for the No treatment group) was used for this analysis. Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available. | Posted | Count of Participants | Participants | Week 8 after last treatment |
|
|
|
| Secondary | Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity. | The Treating Investigator will assess adverse events and record details of seriousness, severity, duration, and action taken with the study device, and relationship to the study device. AEs will be reported from the time of consent until week 52 or to 1 month following the last treatment. | Posted | Count of Participants | Participants | Baseline through Week 52 following the last treatment and 4 weeks following re-treatment |
|
|
|
| Secondary | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | The subjects will receive a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after treatment. The diary will be discussed during telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm). The subject diary captures the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and "other". The 14-day patient CTR diary includes a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate "other" if the subject experienced a sign/symptom that is not listed. The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR). | All numbers are based on the number of total number of subjects who provided diary answers after their treatment. | Posted | Number | number of subjects | During 14 days after initial treatment and touch-up (2 weeks) |
|
|
|
| Secondary | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | The Injection Site Pain (during injection and post-injection) will be self-assessed by the subject using a 100 mm Visual Analog Scale (VAS). VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain. | All numbers are based on the total number of subjects where the data were available. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 2, 12, 16, 24, 36 and 52 |
|
|
|
| Secondary | Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment. | All percentages are based on the total number of subjects where the data were available. | Posted | Mean | Standard Deviation | Proportion of words pronounced correctly | Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment. |
|
|
|
| Secondary | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment. | The following results reports data from subjects who received only the initial treatment (and if applicable, touch-up treatment) in order to confounding recovery with the effect of the new injection cycle(s). | Posted | Mean | Standard Deviation | Proportion of touchpoints with sensation | Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment. |
|
|
|
| Secondary | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment. Lip sensation | The following results reports data from subjects who received only the initial treatment (and if applicable, touch-up treatment) in order to confounding recovery with the effect of the new injection cycle(s). | Posted | Mean | Standard Deviation | Proportion of touchpoints with sensation | Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment. |
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|
|
| Other Pre-specified | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 4 - Baseline score) and (Week 8 - Baseline score). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. | The Intent-to-Treat Population was used for this analysis. For this outcome measure, missing data were imputed using a LOCF (Last Observation Carried Forward) method. | Posted | Count of Participants | Participants | Weeks 4 and 8 after last treatment |
|
|
|
| Other Pre-specified | Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the pre-injection baseline photograph. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. | The Intent-to-Treat Population was used for this analysis. The ITT Population consisted of all subjects randomized in the TEOSYAL RHA® Redensity group and all subjects randomized in the No-Treatment control group (with the notable exception of 1 subject who received treatment with study device at Visit 1 and was censored from the ITT). | Posted | Count of Participants | Participants | Weeks 4 and 8 after last treatment |
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|
|
| Other Pre-specified | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. Change = (Week 8 - Baseline score). | The Intent-to-Treat Population was used for this analysis. The ITT Population consisted of all subjects randomized in the TEOSYAL RHA® Redensity group and all subjects randomized in the No-Treatment control group (with the notable exception of 1 subject who received treatment with study device at Visit 1 and was censored from the ITT). | Posted | Count of Participants | Participants | Week 8 after last treatment |
|
|
|
| Other Pre-specified | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score) and (Week 8 - Baseline score) | The Intent-to-Treat Population was used for this analysis. The ITT Population consisted of all subjects randomized in the TEOSYAL RHA® Redensity group and all subjects randomized in the No-Treatment control group (with the notable exception of 1 subject who received treatment with study device at Visit 1 and was censored from the ITT). | Posted | Count of Participants | Participants | Weeks 4 and 8 after last treatment |
|
|
|
| Other Pre-specified | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. | Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199). | Posted | Count of Participants | Participants | Weeks 8, 12, 16, 24, 36 and 52 after last treatment |
|
|
|
| Other Pre-specified | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score), (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) | Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199). | Posted | Count of Participants | Participants | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment |
|
|
|
| Other Pre-specified | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). For a given subject to be considered a responder, at least 2 of the 3 readers must have confirmed a 1-point improvement for that subject The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) | Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199). | Posted | Count of Participants | Participants | Weeks 8, 12, 16, 24, 36 and 52 after last treatment |
|
|
|
| Other Pre-specified | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) | Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199). | Posted | Count of Participants | Participants | Weeks 8, 12, 16, 24, 36 and 52 after last treatment |
|
|
|
| Other Pre-specified | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score), (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) | Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199). | Posted | Count of Participants | Participants | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment |
|
|
|
| Other Pre-specified | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely'). To calculate the FACE-Q (Perioral Rhytids Domain) score, outcomes from all 6 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. | Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199). | Posted | Mean | Standard Deviation | score on a scale | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment |
|
|
|
| Other Pre-specified | Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. | Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199). | Posted | Count of Participants | Participants | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment |
|
|
|
| Other Pre-specified | Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. | Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199). | Posted | Count of Participants | Participants | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment. |
|
|
|
| Other Pre-specified | Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. | Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199). | Posted | Count of Participants | Participants | Weeks 8, 12, 16, 24, 36 and 52 after last treatment |
|
|
|
| Other Pre-specified | Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied). The No-Treatment control group after treatment was pooled for this exploratory outcome measure. | Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199). | Posted | Count of Participants | Participants | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment |
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|
|
| Other Pre-specified | Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | The natural look and feel of the perioral area was assessed by subjects using an 11-point scale (ranging from 0 to 10). The No-Treatment control group after treatment was pooled for this exploratory outcome measure. | Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199). | Posted | Count of Participants | Participants | Weeks 8, 12, 16, 24, 36 and 52 after last treatment |
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|
|
| Secondary | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment. | The following results reports data from subjects who received only the initial treatment (and if applicable, touch-up treatment), in order to confounding recovery with the effect of the new injection cycle(s). | Posted | Count of Participants | Participants | Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment. |
|
|
|
| 0 |
| 200 |
| 7 |
| 200 |
| 120 |
| 200 |
| EG001 | No Treatment - V1 to V4 | No-Treatment group, before receiving initial treatment. For this pooled analysis, only AEs of subjects from the non-treatment group from V1(Baseline) to V4 (Week 8) are included. | 0 | 49 | 0 | 49 | 7 | 49 |
| EG002 | Treatment Group - V1 to V4 | RHA Redensity group (Treatment group) from V1(Baseline) to V4 (Week 8) are included. | 0 | 151 | 1 | 151 | 74 | 151 |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | unrelated to the study device |
|
| Palpitations | Cardiac disorders | Systematic Assessment | unrelated to the study device |
|
| Pharyngeal Abscess | Infections and infestations | Systematic Assessment | unrelated to the study device |
|
| Intraductal Proliferative Breast Lesion | Reproductive system and breast disorders | Systematic Assessment | unrelated to the study device |
|
| Fallopian Tube Cancer | Reproductive system and breast disorders | Systematic Assessment | unrelated to the study device |
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| Vision Blurred | Eye disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
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| Lip dry | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Injection site bruising | General disorders | Systematic Assessment |
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| Injection site discolouration | General disorders | Systematic Assessment |
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| Injection dryness | General disorders | Systematic Assessment |
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| Injection erythema | General disorders | Systematic Assessment |
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| Injection site hypoaesthesia | General disorders | Systematic Assessment |
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| Injection site induration | General disorders | Systematic Assessment |
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| Injection site mass | General disorders | Systematic Assessment |
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| Injection site movement impairment | General disorders | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
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| Injection site pruritus | General disorders | Systematic Assessment |
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| Injection site scab | General disorders | Systematic Assessment |
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| Injection site swelling | General disorders | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Oral Herpes | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Needle track marks | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Skin wrinkling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin discolouration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Actinic keratosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Melanocytic Naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| hypoaesthesia | Nervous system disorders | Systematic Assessment |
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| Needle track marks | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Week 4 Face-Q Score |
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| Face-Q Change from Baseline to Week 4 |
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| Week 8 Face-Q Score |
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| Face-Q Change from Baseline to Week 8 |
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| Missing values |
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| Week 8 |
|
| Missing values |
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| Missing values |
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| Title | Measurements |
|---|---|
|
| Any Treatment Related Serious Adverse Event |
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| Any Unexpected Adverse Device Effects |
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| Initial Treatment : Tenderness |
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| Initial Treatment : Firmess |
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| Initial Treatment : Swelling |
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| Initial Treatment : Lumps/Bumps |
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| Initial Treatment : Bruising |
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| Initial Treatment : Itching |
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| Initial Treatment : Discoloration |
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| Touch-up Treatment : Redness |
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| Touch-up Treatment : Pain |
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| Touch-up Treatment : Tenderness |
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| Touch-up Treatment : Firmess |
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| Touch-up Treatment : Swelling |
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| Touch-up Treatment : Lumps/Bumps |
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| Touch-up Treatment : Bruising |
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| Touch-up Treatment : Itching |
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| Touch-up Treatment : Discoloration |
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| Week 2 VAS pain score during injection |
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| Week 2 VAS pain score 15 minutes after |
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| Week 12 VAS pain score during injection |
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| Week 12 VAS pain score 15 minutes after |
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| Week 16 VAS pain score during injection |
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| Week 16 VAS pain score 15 minutes after |
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| Week 24 VAS pain score during injection |
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| Week 24 VAS pain score 15 minutes after |
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| Week 36 VAS pain score during injection |
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| Week 36 VAS pain score 15 minutes after |
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| Week 52 VAS pain score during injection |
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| Week 52 VAS pain score 15 minutes after |
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| Week 2 - pre-injection |
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| Week 2 - post-injection |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 24 |
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| Week 36 |
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| Week 52 |
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| Week 2 - pre-injection |
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| Week 2 - post-injection |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 24 |
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| Week 36 |
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| Week 52 |
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| Week 2 - pre-injection |
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| Week 2 - post-injection |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 24 |
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| Week 36 |
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| Week 52 |
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| Missing values |
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| Week 8 |
|
| Missing values |
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| Week 8 |
|
| Missing values |
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| Missing values |
|
| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 24 |
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| Week 36 |
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| Week 52 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 24 |
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| Week 36 |
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| Week 52 |
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| Week 12 |
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| Week 16 |
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| Week 24 |
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| Week 36 |
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| Week 52 |
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| Week 12 |
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| Week 16 |
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| Week 24 |
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| Week 36 |
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| Week 52 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 24 |
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| Week 36 |
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| Week 52 |
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| Face-Q Change from Baseline to Week 4 |
|
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| Week 8 Face-Q Score |
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| Face-Q Change from Baseline to Week 8 |
|
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| Week 12 |
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| Face-Q Change from Baseline to Week 12 |
|
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| Week 16 |
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| Face-Q Change from Baseline to Week 16 |
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| Week 24 |
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| Face-Q Change from Baseline to Week 24 |
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| Week 36 |
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| Face-Q Change from Baseline to Week 36 |
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| Week 52 |
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| Face-Q Change from Baseline to Week 52 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 24 |
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| Week 36 |
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| Week 52 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 24 |
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| Week 36 |
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| Week 52 |
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| Week 12 |
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| Week 16 |
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| Week 24 |
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| Week 36 |
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| Week 52 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 24 |
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| Week 36 |
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| Week 52 |
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| Week 8 : Natural Look and Feel score > and = 7 |
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| Week 12 : Natural Look and Feel score > and = 7 |
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| Week 16 : Natural Look and Feel score > and = 7 |
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| Week 24 : Natural Look and Feel score > and = 7 |
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| Week 36 : Natural Look and Feel score > and = 7 |
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| Week 52 : Natural Look and Feel score > and = 7 |
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| Baseline - post-injection |
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| Week 2 - pre-injection |
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| Week 2 - post-injection |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 24 |
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| Week 36 |
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| Week 52 |
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