A Study of Nutritional Supplementation in Altering Ecchymosis, Erythema and Health Outcomes Associated With Aesthetic Procedures

NCT01919359 | Completed

• 1 other identifier: PS-SUP-12
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Ecchymosis and Erythema Commonly Associated With Soft Tissue Filler Injections

Keywords

ablative laser; soft tissue filler

Outcome Measures

Primary Outcomes (1)

• Canfield Vectra Photography

  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.

  baseline, within 30 minutes post injection/laser, Day 1, Day 3, Day 7 and Day 30.

Secondary Outcomes (1)

• 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

Study Arms (2)

Facial filler w/vitamin,Placebo/Resurfacing w/vitamin, placebo

EXPERIMENTAL

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

Dietary Supplement: Multizyme Cellular Vitality Cyruta Plus SHEP

Soft Tissue filler sugar pill

PLACEBO COMPARATOR

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

Dietary Supplement: Multizyme Cellular Vitality Cyruta Plus SHEP

Interventions

Multizyme Cellular Vitality Cyruta Plus SHEP DIETARY_SUPPLEMENT

Facial filler w/vitamin,Placebo/Resurfacing w/vitamin, placebo; Soft Tissue filler sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 18 or greater.
• Subjects requesting full facial ablative laser resurfacing treatment or soft tissue filler augmentation to the lips and/or malar areas.
• Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:
• postmenopausal for at least 12 months prior to study drug administration
• without a uterus and/or both ovaries
• has had a bilateral tubal ligation for at least 6 months prior to study drug administration.
• absence of an other physical condition according to the PI's discretion
• Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
• Willingness and ability to provide written informed consent prior to performance of any study related procedure.
• Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
• Subjects with a known allergy or sensitivity to any component of the study treatment or anesthesia.
• Subjects who have had prior exposure to any permanent filler in the area(s) to be treated.
• Ablative skin resurfacing on the malar area within the previous 6 months.
• Current history of nutritional supplementation (14 day washout period)
• Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the malar area within 2 weeks prior to study participation or during the study.

Sponsors & Collaborators

• DeNova Research: lead
• Standard Process Inc.: collaborator

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Ecchymosis

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Steven H Dayan, MD FACS

  DeNova Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 9, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2015
• Last Updated: June 1, 2018

Record last verified: 2018-05

Locations

US (1)