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

NCT04029545 | Terminated Phase 3 Results FDA Device

• 1 other identifier: PRO 2019-02
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 5

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.

Conditions

Lip Augmentation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Improved Pain Score From Baseline at Visit 2

  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)

  Visit 1/Day 1 through Visit 2/Month 1, 28 days

Study Arms (3)

PN40082

EXPERIMENTAL

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. The study device will be provided by the Sponsor.

Device: PN40082

RV001 with lidocaine cream

ACTIVE COMPARATOR

RV001 (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 to be used with LMX4, a topical lidocaine. The study device will be provided by the Sponsor. LMX4 will be provided in commercial stock packaging by the Sponsor

Device: PN40082

RV001

EXPERIMENTAL

RV001 (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 to be used alone. The study device will be provided by the Sponsor.

Device: PN40082

Interventions

PN40082 DEVICE

1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.

PN40082; RV001; RV001 with lidocaine cream

Eligibility Criteria

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

You may qualify if:

• Completed Protocol PRO 2018-03 OR Protocol PRO 2018-02 and did not enroll in Protocol PRO 2018-03.
• 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.

You may not qualify if:

• 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.
• Subjects with any mass formation on the lip.
• Subjects that have undergone facial plastic surgery or received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene, polyacrylamide, lifting threads) anywhere in the face or neck, or are planning to be implanted with any of these products during the study.
• Subjects that have 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 are planning to undergo such treatment during the study.
• Subjects that have 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 are planning to undergo any of these procedures during the study.
• that have used ANY lip filling agents within 12 months of study enrollment (hyaluronic acid products, collagen-based products, etc.) other than Investigational Device administered in PRO 2018-02 and PRO-2018-03.

Sponsors & Collaborators

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

Study Sites (5)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

International Dermatology Research, Inc

Miami, Florida, 33144, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Skintastic

Plano, Texas, 75093, United States

Location

Limitations and Caveats

Five subjects were enrolled. The study was placed on hold for the revision of the protocol. After the revision was completed, all eligible subjects had missed the time frame for inclusion in the study. The 5 subjects completed the study. No statistical analysis was performed

Results Point of Contact

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

clinicaltrials@prolleniumus.com

19055081469

Study Officials

• Stacy R Smith, MD

  California Dermatology & Clinical Research Institute

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Injections of the study device are performed by the unblinded Treating Investigator. The blinded Evaluating Investigator is not allowed to retrieve study supplies or to be present during opening of the study supplies or during the injections. The Treating Investigator is not to have any discussion with the Evaluating Investigator or subjects regarding the treatments. Subjects are blinded to treatment assignment. Subjects are physically masked (blindfolded) just prior to and during all injection procedures to prevent observation of the syringes containing study device. Subjects, investigators, the Sponsor's staff conducting the study, and members of the administrative team will not have access to individual subjects' treatment assignments. In the event of an emergency that requires breaking of the study blind, the randomization code will be maintained by each investigator that can be opened to reveal the study device.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 23, 2019
• Study Start: June 14, 2019
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: August 20, 2021
• Results First Posted: August 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)