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

Completed · Phase 3

Conditions studied: Lip Augmentation

In brief

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

Key facts

Study ID

NCT04029519

Run by

Prollenium Medical Technologies Inc.

People needed

84

Starts

2018-12-21

Expected to finish

2019-08-27

Last updated by the study team

2021-07-14

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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