Trials / Completed
CompletedNCT03767153
Clinical Evaluation of Fractional Radiofrequency for the Treatment of Acne Scarring
Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Acne Scarring
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Venus Concept · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring. The study will evaluate 50 treatment sites in subjects requesting treatment of their acne scarring. The study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Venus Viva | The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits. |
Timeline
- Start date
- 2018-11-05
- Primary completion
- 2019-11-22
- Completion
- 2019-12-22
- First posted
- 2018-12-06
- Last updated
- 2021-03-23
- Results posted
- 2021-03-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03767153. Inclusion in this directory is not an endorsement.