A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 84
- Locations
- 6
- Primary Endpoint
- Change From Baseline in Lip Fullness Grading Scale
Study Overview
Brief Summary
To evaluate the safety and efficacy of retreatment with PN40082 for lip augmentation.
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Open Label
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •Exclusion Criteria:
- •Women who are pregnant, lactating, or planning a pregnancy
Arms & Interventions
PN40082
All subjects in this study will receive one open-label treatment with PN40082.
Intervention: PN40082 (Device)
Outcomes
Primary Outcomes
Change From Baseline in Lip Fullness Grading Scale
Time Frame: Visit 1/Day 1 to Visit 3/Month 2, 56 Days
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)
Change From Baseline in Perioral Lines Severity Scale
Time Frame: Visit 1/Day 1 to Visit 3/Month 2, 56 Days
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).
Secondary Outcomes
- 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)