A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation
- Conditions
- Lip Augmentation
- Registration Number
- NCT04029519
- Lead Sponsor
- Prollenium Medical Technologies Inc.
- Brief Summary
To evaluate the safety and efficacy of retreatment with PN40082 for lip augmentation.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- In Protocol PRO 2018-02, the subject was in the per-protocol population, i.e., met all inclusion/exclusion criteria; received study device, completed Visit 5 within the specified window; had LFGS score by the Blinded Evaluating Investigator at Visit 3/Month 2, and had no significant protocol violations that would affect the treatment evaluation.
- If female and of childbearing potential, a negative urine pregnancy test at Visit 1/Day 1 and the subject agrees to use adequate contraception during the study period
- Willing to give written informed consent
- Women who are pregnant, lactating, or planning a pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change From Baseline in Lip Fullness Grading Scale Visit 1/Day 1 to Visit 3/Month 2, 56 Days 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 Perioral Lines Severity Scale Visit 1/Day 1 to Visit 3/Month 2, 56 Days 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).
- Secondary Outcome Measures
Name Time Method Number of Participants With Patient Global Aesthetic Improvement Visit 1/Day 1 to Visit 3/Month 2, 56 days 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)
Number of Participants With Investigator Global Aesthetic Improvement Visit 1/Day 1 to Visit 3/Month 2, 56 days 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)
Number of Subjects With Decreased Swelling Visit 1/Day 1 to Visit 3/Month 2, 56 days Swelling Assessment at Visit 3/Month 2, a 4 point scale with 0 = no swelling (better outcome) up to 4= Severe Swelling (worse outcome)
Trial Locations
- Locations (6)
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
International Dermatology Research, Inc
🇺🇸Miami, Florida, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States
Schweiger Dermatology, PLLC
🇺🇸New York, New York, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Skintastic
🇺🇸Plano, Texas, United States
California Dermatology & Clinical Research Institute🇺🇸Encinitas, California, United States