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

Prollenium Medical Technologies

Status and phase: Completed; Phase 3

Conditions: Lip Augmentation

Treatments: Device: PN40082

Study type: Interventional

Funder types: Industry

Identifiers

NCT04029519

PRO 2018-03

Details and patient eligibility

About

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

Full 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

Enrollment: 84 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

PN40082

Experimental group

Description:

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

Treatment:

Device: PN40082