Clinical Trial: A Study of Nutritional Supplementation in Altering Ecchymosis, Erythema and Health Outcomes Associated With Aesthetic Procedures
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Double-blinded, Randomized Placebo Controlled Study to Assess the Efficacy of Nutritional Supplementation in Altering Ecchymosis, Erythema and Health Outcomes Associated
Brief Summary: Nutritional supplementation is more effective than placebo in the reduction of redness and bruising following facial ablative laser resurfacing treatments and following soft tissue filler injections to the lips and/or malar areas.
Detailed Summary:
Sponsor: DeNova Research
Current Primary Outcome: Canfield Vectra Photography [ Time Frame: baseline, within 30 minutes post injection/laser, Day 1, Day 3, Day 7 and Day 30. ]
The Primary objective of this study is to determine the efficacy of nutritional supplements for the reduction of ecchymosis and erythema associated with aesthetic procedures.
Reduction in ecchymosis and erythema will be determined by evaluation of red, green and blue color values of 3D patient photography using the Canfield Vectra.
Original Primary Outcome: Same as current
Current Secondary Outcome: Heatherton & Polivy State Self-Esteem (HPSS) Scale, (SkinReplica) at Day 30 as compared to baseline (ablative laser group only, Global Aesthetic Improvement Scale (GAIS, [ Time Frame: 30 min post injections- 30 days ]
Original Secondary Outcome: Same as current
Information By: DeNova Research
Dates:
Date Received: August 7, 2013
Date Started: July 2013
Date Completion: October 2014
Last Updated: August 7, 2013
Last Verified: August 2013