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| Name | Class |
|---|---|
| Symbio, LLC | INDUSTRY |
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To evaluate the safety and efficacy of retreatment with PN40082 for lip augmentation.
This is a multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation who received treatment with either PN40082 or Restylane Silk in prior Protocol PRO 2018-02 (NCT04032977). Subjects meeting the inclusion/exclusion criteria will receive a single additional treatment with PN40082
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PN40082 | Experimental | All subjects in this study will receive one open-label treatment with PN40082. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PN40082 | Device | PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Lip Fullness Grading Scale | Lip Fullness Grading Scale is a validated 5-point photonumeric rating scale with 0 being very thin lips (worse outcome) up to 4 full lips (best outcome) | Visit 1/Day 1 to Visit 3/Month 2, 56 Days |
| Change From Baseline in Perioral Lines Severity Scale | Change from baseline in the perioral lines rating scale (POL), a 4 point rating scale with 0 as a mouth with no perioral lines (better outcome) to 3 a mouth with many deep lines or crevices (worse outcome). | Visit 1/Day 1 to Visit 3/Month 2, 56 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Patient Global Aesthetic Improvement | Change from baseline for the patient Global Aesthetic Improvement scale, a 5 point scale with 1= the appearance is worse than the original condition (worse outcome) up to 5 very much improved optimal cosmetic result (better outcome) | Visit 1/Day 1 to Visit 3/Month 2, 56 days |
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Inclusion Criteria:
Exclusion Criteria:
1. Women who are pregnant, lactating, or planning a pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Stacy R. Smith, MD | California Dermatology & Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | United States | ||
| International Dermatology Research, Inc |
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| ID | Title | Description |
|---|---|---|
| FG000 | PN40082 | All subjects in this study will receive one open-label treatment with PN40082. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PN40082 | All subjects in this study will receive one open-label treatment with PN40082. PN40082: PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w. |
| 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 Lip Fullness Grading Scale | Lip Fullness Grading Scale is a validated 5-point photonumeric rating scale with 0 being very thin lips (worse outcome) up to 4 full lips (best outcome) | Change from Baseline in Overall Lips Fullness Grading Scale at Visit3/Month 2. | Posted | Mean | Standard Deviation | score on a scale | Visit 1/Day 1 to Visit 3/Month 2, 56 Days |
|
Adverse events were collected from the time the subject signed informed consent until discharged from the study, approximately 3 months. Follow-up procedures related to pregnancy, AEs, SAEs or AESIs could continue beyond the end of the study, an average of 6 months.
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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 | PN40082 | All subjects in this study will receive one open-label treatment with PN40082. PN40082: PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Beta Hemolytic Streptococcal Infection | Infections and infestations | MedDRA (20) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Bruising | General disorders | MedDRA (20) | Systematic Assessment |
There were no limitations of the trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Affairs | Prollenium Medical Technologies | 1-905-508-1469 | , clinicaltrials@prolleniumus.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 | Nov 13, 2018 | Jun 24, 2021 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2019 | Jun 24, 2021 | SAP_003.pdf |
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multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation
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Open Label
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| Number of Participants With Investigator Global Aesthetic Improvement |
Change from baseline in the Investigator Global Aesthetic Improvement score, a 5 point scale with 1= the appearance is worse than the original condition (worse outcome) up to 5 = very much improved optimal cosmetic result (better outcome) |
| Visit 1/Day 1 to Visit 3/Month 2, 56 days |
| Number of Subjects With Decreased Swelling | Swelling Assessment at Visit 3/Month 2, a 4 point scale with 0 = no swelling (better outcome) up to 4= Severe Swelling (worse outcome) | Visit 1/Day 1 to Visit 3/Month 2, 56 days |
| Miami |
| Florida |
| 33144 |
| United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| Schweiger Dermatology, PLLC | New York | New York | 10022 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Skintastic | Plano | Texas | 75093 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Change From Baseline in Perioral Lines Severity Scale | Change from baseline in the perioral lines rating scale (POL), a 4 point rating scale with 0 as a mouth with no perioral lines (better outcome) to 3 a mouth with many deep lines or crevices (worse outcome). | Change from baseline to Visit 3/Month 2 in the perioral lines rating scale for the 17 subjects who had perioral lines treated. | Posted | Mean | Standard Deviation | score on a scale | Visit 1/Day 1 to Visit 3/Month 2, 56 Days |
|
|
|
| Secondary | Number of Participants With Patient Global Aesthetic Improvement | Change from baseline for the patient Global Aesthetic Improvement scale, a 5 point scale with 1= the appearance is worse than the original condition (worse outcome) up to 5 very much improved optimal cosmetic result (better outcome) | Change from baseline in the Patient Global Aesthetic Improvement scale with 5 being much improved optimal cosmetic results (better outcome) and 1 being the appearance is worse than the original condition (worse outcome) | Posted | Count of Participants | Participants | Visit 1/Day 1 to Visit 3/Month 2, 56 days |
|
|
|
| Secondary | Number of Participants With Investigator Global Aesthetic Improvement | Change from baseline in the Investigator Global Aesthetic Improvement score, a 5 point scale with 1= the appearance is worse than the original condition (worse outcome) up to 5 = very much improved optimal cosmetic result (better outcome) | Change from baseline in the Investigator Global Aesthetic Improvement score with 1 being appearance is worse than the original condition (worse outcome) up to 5 being very much improved optimal cosmetic result (better outcome) | Posted | Count of Participants | Participants | Visit 1/Day 1 to Visit 3/Month 2, 56 days |
|
|
|
| Secondary | Number of Subjects With Decreased Swelling | Swelling Assessment at Visit 3/Month 2, a 4 point scale with 0 = no swelling (better outcome) up to 4= Severe Swelling (worse outcome) | Swelling assessment at Visit 3/Month 2 with 0 = no swelling (better outcome) up to 4 = severe swelling (worse outcome) | Posted | Count of Participants | Participants | Visit 1/Day 1 to Visit 3/Month 2, 56 days |
|
|
|
| 0 |
| 84 |
| 1 |
| 84 |
| 61 |
| 84 |
| Stenosis in Sigmoid Colon | Gastrointestinal disorders | MedDRA (20) | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA (20) | Systematic Assessment |
|
| Injection site mass | General disorders | MedDRA (20) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (20) | Systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA (20) | Systematic Assessment |
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| Facial Asymmetry | Musculoskeletal and connective tissue disorders | MedDRA (20) | Systematic Assessment |
|
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| No change (2) |
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| Worse (1) |
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| No Change (2) |
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| Worse (1) |
|