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 ]

to evaluate the effects of nutritional supplementation with the following assessments: Improvement in self-esteem at all follow-up visits compared to baseline as assessed using the Heatherton & Polivy State Self-Esteem (HPSS) Scale Improvement in fine lines and wrinkles in the crow's feet area as assessed using silicon profilometry (SkinReplica) at Day 30 as compared to baseline (ablative laser group only) Improvement in aesthetic appearance at all follow-up visits as assessed by the subject's assessments of photography from the Canfield Vectra 3D Imaging Severity of ecchymosis assessed using a 5-point categorical scale within 30 minutes post injection/laser and all subsequent follow up visits Severity of erythema as assessed using a 4-point scale within 30 minutes post injection/laser and all subsequent follow up visits Subject satisfaction with healing assessed at Day 7 and 30 Severity and duration of adverse events measured by 30-day patient diary


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