A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation

NCT04029519 | Completed Phase 3 Results FDA Device

• 1 other identifier: PRO 2018-03
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 6

Brief Summary

To evaluate the safety and efficacy of retreatment with PN40082 for lip augmentation.

Conditions

Lip Augmentation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Number of Participants With Patient Global Aesthetic Improvement

  Visit 1/Day 1 to Visit 3/Month 2, 56 days

• Number of Participants With Investigator Global Aesthetic Improvement

  Visit 1/Day 1 to Visit 3/Month 2, 56 days

• Number of Subjects With Decreased Swelling

  Visit 1/Day 1 to Visit 3/Month 2, 56 days

Study Arms (1)

PN40082

EXPERIMENTAL

All subjects in this study will receive one open-label treatment with PN40082.

Device: PN40082

Interventions

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.

PN40082

Eligibility Criteria

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (6)

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

Schweiger Dermatology, PLLC

New York, New York, 10022, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Skintastic

Plano, Texas, 75093, United States

Location

Limitations and Caveats

There were no limitations of the trial.

Results Point of Contact

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

, clinicaltrials@prolleniumus.com

1-905-508-1469

Study Officials

• Stacy R. Smith, MD

  California Dermatology & Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 23, 2019
• Study Start: December 21, 2018
• Primary Completion: August 27, 2019
• Study Completion: August 27, 2019
• Last Updated: July 14, 2021
• Results First Posted: July 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)