A Study of Nutritional Supplementation in Altering Ecchymosis, Erythema and Health Outcomes Associated With Aesthetic Procedures
- Conditions
- Ecchymosis and Erythema Commonly Associated With Soft Tissue Filler Injections
- Interventions
- Dietary Supplement: Multizyme Cellular Vitality Cyruta Plus SHEP
- Registration Number
- NCT01919359
- Lead Sponsor
- DeNova Research
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Soft Tissue filler sugar pill Multizyme Cellular Vitality Cyruta Plus SHEP Placebo Analog 2tabs 2 times/day between meals; Day of tx for 30 days; Placebo Analog 1tab 3 times/day 30 days before and after tx or Placebo Analog (A) 2 1cap 2 times/day between meals; Day of Tx for 30 days Placebo Analog (B) 2caps 2 times/day 30 days before and after Tx Placebo Analog (C) 1cap 3 times/day 30 days before and after Tx Facial filler w/vitamin,Placebo/Resurfacing w/vitamin, placebo Multizyme Cellular Vitality Cyruta Plus SHEP Multizyme 150C 2 caps 2 times/day between meals Day of tx for 30 days Cyruta Plus 90T 1 cap 3 times/day 30 days before and after tx or Multizyme 150C 2caps 2 times/day between meals Day of Tx for 30 days; SHEP 2caps 2 times/day 30 days before and after Tx Cellular Vitality 90C 1cap 3 times/day 30 days before and after Tx
- Primary Outcome Measures
Name Time Method Canfield Vectra Photography 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.
- Secondary Outcome Measures
Name Time Method Heatherton & Polivy State Self-Esteem (HPSS) Scale, (SkinReplica) at Day 30 as compared to baseline (ablative laser group only, Global Aesthetic Improvement Scale (GAIS, 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
Trial Locations
- Locations (1)
DeNova Research
🇺🇸Chicago, Illinois, United States