Safety and Effectiveness of PN40082 for Lip Augmentation

NCT04032977 | Completed Results

• 1 other identifier: PRO 2018-02
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the safety and efficacy profile of PN40082 versus Restylane Silk Injectable Gel with 0.3% lidocaine (Restylane Silk) for lip augmentation in approximately 158 subjects.

Conditions

Lip Augmentation

Outcome Measures

Primary Outcomes (1)

• Change in Overall Lip Fullness Grading Scale

  The Lip Fullness Grading Scale is a 5 point photonumeric rating scale with 0 being very thin lips (worse outcome) up to 4 being full lips (better outcome)

  Visit 1 baseline to Visit 3 Month 2, 56 days

Secondary Outcomes (4)

• Treatment Success Lip Fullness Grading Scale

  Visit 1 baseline to Visit 3 Month 2, 56 days

• Treatment Success Perioral Lines Severity Scale

  Visit 1 baseline to Visit 4 Month 3, 84 days

• Change From Baseline to Visit 4/Month 3 in Overall Lip Fullness Grading Scale

  Visit 1 baseline to Visit 4 Month 3, 84 days

• Change From Baseline to Visit 5/Month 6 in Overall Lip Fullness Grading Scale

  Visit 1 baseline to Visit 5 Month 6, 168 days

Study Arms (2)

PN40082

EXPERIMENTAL

Test 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

Device: PN40082; Device: Restylane Silk

Restylane Silk

ACTIVE COMPARATOR

Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.

Device: PN40082; Device: Restylane Silk

Interventions

PN40082 DEVICE

To provide a 1-point improvement in the lip fullness grading scale score of subjects with very thin or thin lips or subjects with Fitzpatrick IV, V or VI to improve the LFGS score by 1 for 1 or both lips

PN40082; Restylane Silk

Restylane Silk DEVICE

To provide a 1-point improvement in the lip fullness grading scale score of subjects with very thin or thin lips or subjects with Fitzpatrick IV, V or VI to improve the LFGS score by 1 for 1 or both lips

PN40082; Restylane Silk

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or non-pregnant or non-breastfeeding women over 21 years of age
• If female and of childbearing potential, a negative urine pregnancy test at Baseline (Day 1) and the subject agrees to use adequate contraception during the study period
• Has 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 Has 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
• Willing to give written informed consent

You may not qualify if:

• Women who are pregnant, lactating, or planning a pregnancy
• History of allergy, anaphylaxis or hypersensitivity to injectable hyaluronic acid products, local anesthetics of the amide type such as lidocaine, or to latex, or is planning to undergo desensitization therapy during the study
• Has lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
• Has abnormal lip function, with inability to effectively sip water through a straw
• Has abnormal lip sensation, with inability to feel a 0.4G monofilament or a cotton wisp at any site on the lip
• Has moderate or severe abnormal lip asymmetry
• Has any mass formation on the lip
• Has undergone facial plastic surgery or received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene, polyacrylamide, lifting threads) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
• Has undergone semi-permanent dermal filler treatment (e.g., calcium hydroxylapatite, poly-L-lactic acid) in the lower face (below the orbital rim) within 12 months before enrollment or is planning to undergo such treatment during the study
• Has undergone facial tissue augmentation with fat injections, botulinum toxin injections in the lower face (below the orbital rim), mesotherapy, or cosmetic procedures in the face or neck (e.g., face-lift, laser, photo-modulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, microneedling, or other ablative procedures) within 9 months before enrollment or is planning to undergo any of these procedures during the study
• Has used ANY lip filling agents within 12 months of study enrollment (hyaluronic acid products, collagen-based products, etc.)
• Has used any lip plumping products or devices within 10 days before enrollment or is planning to use such products during the study
• Has begun using any over-the-counter (OTC) or prescription oral or topical anti wrinkle products for the lips or around the mouth within 90 days before enrollment or is planning to begin using such products during the study (Subjects who have been on a stable regimen of such products for at least 90 days are eligible for the study and must continue their regimen throughout the study.)
• Is on an ongoing regimen of anticoagulation therapy (e.g., warfarin), 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 of undergoing study device injections. Subjects who will withhold such therapy for 10 days before AND after any injection session may participate
• Has a history or presence of bleeding disorders

Sponsors & Collaborators

• Prollenium Medical Technologies Inc.: lead
• Symbio, LLC: collaborator

Study Sites (1)

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Limitations and Caveats

Due to blinded randomization, no men were randomized into the PN40082 group. Pooled analysis was provided to the FDA from previous studies to demonstrate safety in men. Not enough subjects were randomized that required treatment of their perioral lines to demonstrate statistically non-inferiority.

Results Point of Contact

• Title: Director Clinical Affairs
• Organization: Prollenium Medical Technologies

clinicaltrials@prolleniumus.com

1-905-508-1469

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the unblinded treating investigator and unblinded assistant will be unblinded to the treatment. The remainder of study/site personnel remain blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, controlled, multicenter clinical study

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 25, 2019
• Study Start: July 13, 2018
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: July 12, 2021
• Results First Posted: July 12, 2021

Record last verified: 2021-05

Locations

US (1)