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

Lip Augmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04029519
• Other study ID #: PRO 2018-03
• Status: Completed
• Phase: Phase 3
• Start date: December 21, 2018
• Est. completion date: August 27, 2019

Study information

• Verified date: June 2021
• Source: Prollenium Medical Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 27, 2019
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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

3. Willing to give written informed consent

Exclusion Criteria:

1. Women who are pregnant, lactating, or planning a pregnancy

Related Conditions & MeSH terms

• Lip Augmentation

Intervention

Device:
• PN40082
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.

Locations

Country	Name	City	State
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	International Dermatology Research, Inc	Miami	Florida
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Schweiger Dermatology, PLLC	New York	New York
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Skintastic	Plano	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Prollenium Medical Technologies Inc.	Symbio, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants With Patient Global Aesthetic Improvement	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)	Visit 1/Day 1 to Visit 3/Month 2, 56 days
Secondary	Number of Participants With Investigator Global Aesthetic Improvement	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)	Visit 1/Day 1 to Visit 3/Month 2, 56 days
Secondary	Number of Subjects With Decreased Swelling	Swelling Assessment at Visit 3/Month 2, a 4 point scale with 0 = no swelling (better outcome) up to 4= Severe Swelling (worse outcome)	Visit 1/Day 1 to Visit 3/Month 2, 56 days