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To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Dermal Filler | Experimental | hyaluronic acid |
|
| Dermal Filler | Active Comparator | hyaluronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Dermal Filler | Device | hyaluronic acid |
| |
| Device: FDA Approved Dermal Filler |
| Measure | Description | Time Frame |
|---|---|---|
| Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS) | The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness (grades 0-5, with a higher score reflecting greater lip fullness) was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline at 8 weeks after last injection of New Dermal Filler or Dermal Filler (control). | 8 weeks after last injection |
| Measure | Description | Time Frame |
|---|---|---|
| Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness (grades 0-5, with a higher score reflecting greater lip fullness) was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline at X weeks after last injection of New Dermal Filler. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate All Reported Adverse Events | 48 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Testing of Bevelry Hills | Encino | California | 91436 | United States | ||
| Cosmetic Laser Dermatology |
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| ID | Title | Description |
|---|---|---|
| FG000 | New Dermal Filler | hyaluronic acid New Dermal Filler: hyaluronic acid |
| FG001 | Dermal Filler | hyaluronic acid Device: FDA Approved Dermal Filler: hyaluronic acid |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One subject randomized to control (Dermal Filler) group but received New Dermal filler in error; therefore they are included in the New Dermal Filler group.Three subjects had baseline MLFS = 5 and were excluded from ITT population.
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| ID | Title | Description |
|---|---|---|
| BG000 | New Dermal Filler | hyaluronic acid New Dermal Filler: hyaluronic acid |
| BG001 | Dermal Filler | hyaluronic acid Device: FDA Approved Dermal Filler: hyaluronic acid |
| 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 | Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS) | The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness (grades 0-5, with a higher score reflecting greater lip fullness) was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline at 8 weeks after last injection of New Dermal Filler or Dermal Filler (control). | Posted | Mean | Standard Deviation | Change in MLFS score from baseline | 8 weeks after last injection |
|
1 year
One subject randomized to the dermal filler group received the new dermal filler in error. This subject is included in the new dermal filler group for safety analysis.
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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 | New Dermal Filler | hyaluronic acid New Dermal Filler: hyaluronic acid | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | MedDRA (10.0) | Systematic Assessment | Related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | QMedAB | (817) 961-5000 | aestheticclinicaltrials@galderma.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 | Aug 17, 2017 | May 21, 2020 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 25, 2018 | May 21, 2020 | SAP_003.pdf |
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| Device |
hyaluronic acid |
|
| 16, 24, 32, 40, and 48 weeks after last injection |
| Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Based on Response Rates (defined as at least 1 point improvement from baseline) after treatment with New Dermal Filler | 16, 24, 32, 40, and 48 weeks |
| Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Based on Change from Baseline, New Dermal Filler using WAS. Scoring of the upper perioral rhytids and oral commissures was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Scoring of fold severity was based on visual assessment of the length and apparent depth of the wrinkle at a certain time-point and measured on a 6-point scale, with 0 being no wrinkle and 5 being very deep wrinkle/redundant fold. | 8, 16, 24, 32, 40, and 48 weeks after last injection |
| Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Based on Response Rates (defined as at least 1 point improvement from baseline), New Dermal Filler using WAS. Scoring of the upper perioral rhytids and oral commissures was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Scoring of fold severity was based on visual assessment of the length and apparent depth of the wrinkle at a certain time-point and measured on a 6-point scale, with 0 being no wrinkle and 5 being very deep wrinkle/redundant fold. . | 8, 16, 24, 32, 40, and 48 weeks |
| Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment | Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by subject, upper and lower lip combined, New Dermal Filler | 8, 16, 24, 32, 40, and 48 weeks |
| Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator | Determined by Response Rates, Treating Investigator Assessment, New Dermal Filler | 8, 16, 24, 32, 40, and 48 weeks |
| Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer | Proportion of Improvement (Responders) Based on Independent Photographic Reviewer Assessment by Weeks after Last Injection, New Dermal Filler | 8, 24, 40, and 48 weeks |
| Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q | Subjects' satisfaction using the validated FACE-Q scales Satisfaction with Lips and Appraisal of Lines: Lips at baseline and at Week 8, 16, 24, 32, 40, and 48 weeks after last injection based on individual questions in each questionnaire as well as the Rasch transformed total scores and the change from baseline in the Rasch transformed scores. Rasch-transformed total score (0-100) according the FACE-Q manual; the higher total score indicated greater subject satisfaction.A positive change from baseline indicates an improvement. Baseline is defined as the last observation before initial treatment takes place at the baseline visit on Day 1. | 8, 16, 24, 32, 40, and 48 weeks |
| San Diego |
| California |
| 92121 |
| United States |
| Art of Skin MD | Solana Beach | California | 92075 | United States |
| Skin Research Institute, LLC | Coral Gables | Florida | 33146 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Research Institute of SouthEast | West Palm Beach | Florida | 33401 | United States |
| Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta | Georgia | 30022 | United States |
| Maryland Dermatology, Laser, Skin & Vein Institute | Hunt Valley | Maryland | 21030 | United States |
| SkinCare Physicians | Chestnut Hill | Massachusetts | 02467 | United States |
| BOYD | Birmingham | Michigan | 48009 | United States |
| Laser & Skin Surgery Center of New York | New York | New York | 10016 | United States |
| Aesthetic Solutions, PA | Chapel Hill | North Carolina | 27517 | United States |
| Brian S. Biesman, MD | Nashville | Tennessee | 37203 | United States |
| Center for Advanced Clinical Research | Dallas | Texas | 75254 | United States |
| moved out of state |
|
| could not complete final visit |
|
| 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 (FST) | I (White, very fair, red or blond hair, blue eyes, freckles) II (White, fair, red or blond hair; blue, hazel or geen eyes) III (Cream white, fair with any eye or hair color, very common) IV (Brown, typical Mediterranean Caucasian skin) V (Dark brown, Middle Eastern skin type) VI (Black) | Count of Participants | Participants |
|
hyaluronic acid Device: FDA Approved Dermal Filler: hyaluronic acid |
|
|
| Secondary | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness (grades 0-5, with a higher score reflecting greater lip fullness) was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline at X weeks after last injection of New Dermal Filler. | Observed cases at each visit, New Dermal Filler | Posted | Mean | Standard Deviation | score on a scale | 16, 24, 32, 40, and 48 weeks after last injection |
|
|
|
| Secondary | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Based on Response Rates (defined as at least 1 point improvement from baseline) after treatment with New Dermal Filler | Responder is defined as subjects with at least one point improvement from baseline MLFS (blinded evaluator). Response in both lips concurrently. | Posted | Count of Participants | Participants | 16, 24, 32, 40, and 48 weeks |
|
|
|
| Secondary | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Based on Change from Baseline, New Dermal Filler using WAS. Scoring of the upper perioral rhytids and oral commissures was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Scoring of fold severity was based on visual assessment of the length and apparent depth of the wrinkle at a certain time-point and measured on a 6-point scale, with 0 being no wrinkle and 5 being very deep wrinkle/redundant fold. | Number observed at each visit, New Dermal Filler | Posted | Mean | Standard Deviation | change in WAS score from baseline | 8, 16, 24, 32, 40, and 48 weeks after last injection |
|
|
|
| Secondary | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Based on Response Rates (defined as at least 1 point improvement from baseline), New Dermal Filler using WAS. Scoring of the upper perioral rhytids and oral commissures was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Scoring of fold severity was based on visual assessment of the length and apparent depth of the wrinkle at a certain time-point and measured on a 6-point scale, with 0 being no wrinkle and 5 being very deep wrinkle/redundant fold. . | Observed cases at each visit | Posted | Count of Participants | Participants | 8, 16, 24, 32, 40, and 48 weeks |
|
|
|
| Secondary | Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment | Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by subject, upper and lower lip combined, New Dermal Filler | Observed cases at each visit, New Dermal Filler | Posted | Count of Participants | Participants | 8, 16, 24, 32, 40, and 48 weeks |
|
|
|
| Secondary | Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator | Determined by Response Rates, Treating Investigator Assessment, New Dermal Filler | Observed cases at each visit | Posted | Count of Participants | Participants | 8, 16, 24, 32, 40, and 48 weeks |
|
|
|
| Secondary | Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer | Proportion of Improvement (Responders) Based on Independent Photographic Reviewer Assessment by Weeks after Last Injection, New Dermal Filler | Observed cases at each visit. Response is defined as an improvement from baseline assessed via random, blinded pairing and review of the baseline and post-baseline photographs | Posted | Count of Participants | Participants | 8, 24, 40, and 48 weeks |
|
|
|
| Secondary | Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q | Subjects' satisfaction using the validated FACE-Q scales Satisfaction with Lips and Appraisal of Lines: Lips at baseline and at Week 8, 16, 24, 32, 40, and 48 weeks after last injection based on individual questions in each questionnaire as well as the Rasch transformed total scores and the change from baseline in the Rasch transformed scores. Rasch-transformed total score (0-100) according the FACE-Q manual; the higher total score indicated greater subject satisfaction.A positive change from baseline indicates an improvement. Baseline is defined as the last observation before initial treatment takes place at the baseline visit on Day 1. | Observed cases at each visit, New Dermal Filler | Posted | Mean | Standard Deviation | score on a scale | 8, 16, 24, 32, 40, and 48 weeks |
|
|
|
| Other Pre-specified | Evaluate All Reported Adverse Events | Safety population, Initial and Touch-up Treatment. One subject randomized to the dermal filler group received the new dermal filler in error. This subject is included in the new dermal filler group for safety analysis | Posted | Count of Participants | Participants | 48 weeks |
|
|
|
| 185 |
| 2 |
| 185 |
| 43 |
| 185 |
| EG001 | Dermal Filler | hyaluronic acid Device: FDA Approved Dermal Filler: hyaluronic acid | 0 | 88 | 0 | 88 | 25 | 88 |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| injection site mass | General disorders | MedDRA (10.0) | Systematic Assessment | Related |
|
| injection site nodule | General disorders | MedDRA (10.0) | Systematic Assessment | Related |
|
PIs agree not to present or publish any data or reports collected individually or by subgroup of sites prior to full, initial publication based on all data obtained from all sites.
|
| Upper lip Week 24 |
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| Lower lip Week 24 |
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| Upper lip Week 32 |
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| Lower lip Week 32 |
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| Upper lip Week 40 |
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| Lower lip Week 40 |
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| Upper lip Week 48 |
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| Lower lip Week 48 |
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| Week 32 |
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| Week 40 |
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| Week 48 |
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| Upper Perioral Lines, Week 24 |
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| Upper Perioral Lines, Week 32 |
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| Upper Perioral Lines, Week 40 |
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| Upper Perioral Lines, Week 48 |
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| Left oral commissure Week 8 |
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| Right oral commissure Week 8 |
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| Left oral commissure Week 16 |
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| Right oral commissure Week 16 |
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| Left oral commissure Week 24 |
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| Right oral commissure Week 24 |
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| Left oral commissure Week 32 |
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| Right oral commissure Week 32 |
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| Left oral commissure Week 40 |
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| Right oral commissure Week 40 |
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| Left oral commissure Week 48 |
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| Right oral commissure Week 48 |
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| Upper Perioral Lines, Week 24 |
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| Upper Perioral Lines, Week 32 |
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| Upper Perioral Lines, Week 40 |
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| Upper Perioral Lines, Week 48 |
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| Left oral commissure Week 8 |
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| Left oral commissure Week 16 |
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| Left oral commissure Week 24 |
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| Left oral commissure Week 32 |
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| Left oral commissure Week 40 |
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| Left oral commissure Week 48 |
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| Right oral commissure Week 8 |
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| Right oral commissure Week 16 |
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| Right oral commissure Week 24 |
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| Right oral commissure Week 32 |
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| Right oral commissure Week 40 |
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| Right oral commissure Week 48 |
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| Week 24 |
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| Week 32 |
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| Week 40 |
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| Week 48 |
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| Upper and lower lip combined, Week 24 |
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| Upper and lower lip combined, Week 32 |
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| Upper and lower lip combined, Week 40 |
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| Upper and lower lip combined, Week 48 |
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| Upper lip, Week 24 |
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| Lower lip, Week 24 |
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| Upper lip, Week 40 |
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| Lower lip, Week 40 |
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| Upper lip, Week 48 |
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| Lower lip, Week 48 |
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| Week 16 |
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| Week 24 |
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| Week 32 |
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| Week 40 |
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| Week 48 |
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| TEAE related to product and/or injection procedure |
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| Serious TEAEs, related |
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| Unrelated TEAE |
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| No TEAEs |
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