VBeam Prima for Treatment of Photoaged Facial Skin
|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: NCT03383705|
Recruitment Status : Unknown
Verified December 2017 by Syneron Medical.
Recruitment status was: Recruiting
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Photoaged Facial Skin||Device: VBeam Prima||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||VBeam Prima for Treatment of Photoaged Facial Skin|
|Actual Study Start Date :||November 15, 2017|
|Estimated Primary Completion Date :||November 15, 2018|
|Estimated Study Completion Date :||November 15, 2018|
|Experimental: Treatment arm||
Device: VBeam Prima
Up to four treatments will be performed every 4-6 (±1) weeks.
- Global Improvement Scale [ Time Frame: 1 or 3 months post last treatment ]Overall improvement using Global Improvement Scale (0=no response; 4=excellent response).
- Wrinkle and Elastosis Score [ Time Frame: Pre Tx.4, 1 month and 3 months post final treatment ]Improvement using Fitzpatrick Wrinkle Class and Elastosis Score
- Treatment discomfort based on NRS Scale [ Time Frame: Immediately post treatment ]Evaluate treatment discomfort based on NRS Scale as reported by study subjects
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): NCT03383705
|Contact: Gilly Munavalli, MD||(704) firstname.lastname@example.org|
|Contact: Cindy Tucker, RN-C||(704) email@example.com|
|United States, North Carolina|
|Dermatology, Laser & Vein Specialists of the Carolinas||Recruiting|
|Charlotte, North Carolina, United States, 28207|
|Contact: Cindy Tucker, RN-C 704-375-6766|