Trials / Completed
CompletedNCT04029519
A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- Prollenium Medical Technologies Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-12-21
- Primary completion
- 2019-08-27
- Completion
- 2019-08-27
- First posted
- 2019-07-23
- Last updated
- 2021-07-14
- Results posted
- 2021-07-14
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04029519. Inclusion in this directory is not an endorsement.