A Multicenter, Double-blind, Randomized, Controlled, Roll-over Retreatment Study of the Safety and Pain Associated With Injections of PN40082, RV001 With Topical Anesthetic or RV001 for Lip Augmentation
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Lip Augmentation
- Sponsor
- Prollenium Medical Technologies Inc.
- Enrollment
- 5
- Locations
- 5
- Primary Endpoint
- Number of Participants With Improved Pain Score From Baseline at Visit 2
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety of repeat injections and pain associated with injection of PN40082 and comparative pain associated with RV001 with a topical anesthetic and RV001 for lip augmentation.
Detailed Description
This is a multicenter, double-blind, randomized, controlled, roll-over retreatment 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), and PN40082 in prior Protocol PRO 2018-03 (NCT04029519). Subjects meeting the inclusion/exclusion criteria will receive a single additional treatment with either RV001, RV001 with a topical anesthetic, or PN40082. The Evaluating Investigator will be blinded to the treatment. Injections of the study device will be performed by an unblinded Treating Investigator.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Completed Protocol PRO 2018-03 OR Protocol PRO 2018-02 and did not enroll in Protocol PRO 2018-
- •Men or non-pregnant or non-breastfeeding women over 21 years of age
- •At PRO 2018-02 baseline visit had an overall score of very thin, or thin on the LFGS, as agreed upon by the Treating and Evaluating Investigators, and desires at least a 1-point improvement in overall LFGS score; OR Had a Fitzpatrick skin phototype IV, V or VI and has an LFGS score of thick or full, as agreed upon by the Treating and Evaluating Investigators, and desires treatment to the vermilion body of 1 or both lips
- •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.
Exclusion Criteria
- •Women who are pregnant, lactating, or planning a pregnancy.
- •Subjects with a known history of allergy, anaphylaxis or hypersensitivity to injectable hyaluronic acid products, local anesthetics of the amide type such as lidocaine, or to latex.
- •Subjects with a significant ongoing adverse event from PRO 2018-02 or PRO 2018-03 that in the opinion of the investigator could be worsened by participation in this study.
- •Subjects that experienced an SAE, AESI, visual changes or other serious medical conditions during PRO 2018-02 or PRO 2018-03
- •Subjects who are unable to withhold thrombolytics, or inhibitors of platelet aggregation or nonsteroidal anti inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or gingko) within 10 days before AND after any injection session.
- •Subjects with clinically significant organic disease including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, preclude participation in the trial.
- •Subjects with lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments.
- •Subjects with abnormal lip function, with inability to effectively sip water through a straw.
- •Subjects with abnormal lip sensation with inability to feel a 0.4G monofilament or a cotton wisp at any site on the lip.
- •Subjects with moderate or severe abnormal lip asymmetry.
Outcomes
Primary Outcomes
Number of Participants With Improved Pain Score From Baseline at Visit 2
Time Frame: Visit 1/Day 1 through Visit 2/Month 1, 28 days
Compare subject pain scores with a 100 mm visual analog scale with 00 being no pain (better outcome) and 100 being worst possible pain (worse outcome)