Clinical Evaluation of Fractional Radiofrequency for the Treatment Acne Scarring
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03821324|
Recruitment Status : Active, not recruiting
First Posted : January 29, 2019
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acne Scars||Device: Venus Viva||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Blinded evaluation of photographs taken at baseline and at 6, 12 weeks post final treatment by independent evaluators.|
|Official Title:||Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Acne Scarring|
|Actual Study Start Date :||December 11, 2018|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
Device: Venus Viva
Device: Venus Viva
The Venus Viva™ fractional RF device 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.
- Acne Scar Improvement [ Time Frame: 6 and 12 Weeks Post-Final Treatment ]Change in acne scarring at 6 weeks and 12 weeks post-intervention compared to baseline as assessed by blinded evaluators by photographic assessment utilizing a 7 point Global Aesthetic Improvement Scale (GAIS) for acne scarring.
- Subject Satisfaction [ Time Frame: 6 and 12 Weeks Post- Final Treatment ]Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale at 6 weeks and 12 weeks post-treatment.
- Subject Scale - Visual Analog Scale for Pain [ Time Frame: Up to 3 Months Post Enrollment ]Subjects' assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS).
- Incidence of Treatment-Related Adverse Events [ Time Frame: Up to 12 Weeks Post-Final Treatment ]Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment.
- Subject Scale - 5 Point Scale for Treatment Tolerability [ Time Frame: Up to 3 Months Post Enrollment ]Subjects' assessment of treatment tolerability as measured by a 5 point scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821324
|United States, New York|
|Sadick Research Group|
|New York, New York, United States, 10075|
|Study Director:||Paul Cardarelli||Venus Concept|