Phase 3
N=84
A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation
Lip Augmentation
Bottom Line
View on ClinicalTrials.gov: NCT04029519 ↗Enrolled (actual)
84
Serious AEs
1.2%
Results posted
Jul 2021
Primary outcome: Primary: Change From Baseline in Lip Fullness Grading Scale — .82 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PN40082 (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Prollenium Medical Technologies Inc.
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Lip Fullness Grading Scale |
.82 | — |
| PRIMARY Change From Baseline in Perioral Lines Severity Scale |
-0.75 | — |
| SECONDARY Number of Participants With Patient Global Aesthetic Improvement |
41; 19; 17; 2; 0 | — |
| SECONDARY Number of Participants With Investigator Global Aesthetic Improvement |
28; 30; 20; 1; 0 | — |
| SECONDARY Number of Subjects With Decreased Swelling |
79 | — |
Summary
To evaluate the safety and efficacy of retreatment with PN40082 for lip augmentation.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04029519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.