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

Primary Purpose

Ecchymosis and Erythema Commonly Associated With Soft Tissue Filler Injections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multizyme Cellular Vitality Cyruta Plus SHEP
Sponsored by
DeNova Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ecchymosis and Erythema Commonly Associated With Soft Tissue Filler Injections focused on measuring ablative laser, soft tissue filler

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  1. Males and females aged 18 or greater.
  2. Subjects requesting full facial ablative laser resurfacing treatment or soft tissue filler augmentation to the lips and/or malar areas.
  3. Subjects willing to abstain from exclusionary procedures in the treatment area (i.e., injectable fillers, laser or chemical resurfacing, botulinum toxin type A, facial cosmetic surgery).
  4. Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
  5. 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
  6. Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
  7. Willingness and ability to provide written informed consent prior to performance of any study related procedure.

Exclusionary Criteria

  1. Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
  2. Subjects with a known allergy or sensitivity to any component of the study treatment or anesthesia.
  3. Subjects who have had prior exposure to any permanent filler in the area(s) to be treated.
  4. Ablative skin resurfacing on the malar area within the previous 6 months.
  5. Current history of nutritional supplementation (14 day washout period)
  6. Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the malar area within 2 weeks prior to study participation or during the study.
  7. Active infection in the malar area (e.g., acute acne lesions or ulcers).
  8. Current history of chronic drug or alcohol abuse.
  9. History of autoimmune disease.
  10. Current history of blood thinners (aspirin, ibuprofen, naprosyn, herbal supplements, Vitamin E, etc.)
  11. Current history of tobacco use
  12. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
  13. Subjects who anticipate the need for surgery or overnight hospitalization during the study.
  14. Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability.
  15. Enrollment in any active study involving the use of investigational devices or drugs.

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Sites / Locations

  • DeNova Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

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

Soft Tissue filler sugar pill

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Heatherton & Polivy State Self-Esteem (HPSS) Scale, (SkinReplica) at Day 30 as compared to baseline (ablative laser group only, Global Aesthetic Improvement Scale (GAIS,
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

Full Information

First Posted
August 7, 2013
Last Updated
May 30, 2018
Sponsor
DeNova Research
Collaborators
Standard Process Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01919359
Brief Title
A Study of Nutritional Supplementation in Altering Ecchymosis, Erythema and Health Outcomes Associated With Aesthetic Procedures
Official Title
A Double-blinded, Randomized Placebo Controlled Study to Assess the Efficacy of Nutritional Supplementation in Altering Ecchymosis, Erythema and Health Outcomes Associated With Aesthetic Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DeNova Research
Collaborators
Standard Process Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ecchymosis and Erythema Commonly Associated With Soft Tissue Filler Injections
Keywords
ablative laser, soft tissue filler

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Facial filler w/vitamin,Placebo/Resurfacing w/vitamin, placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Soft Tissue filler sugar pill
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Multizyme Cellular Vitality Cyruta Plus SHEP
Primary Outcome Measure Information:
Title
Canfield Vectra Photography
Description
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.
Time Frame
baseline, within 30 minutes post injection/laser, Day 1, Day 3, Day 7 and Day 30.
Secondary Outcome Measure Information:
Title
Heatherton & Polivy State Self-Esteem (HPSS) Scale, (SkinReplica) at Day 30 as compared to baseline (ablative laser group only, Global Aesthetic Improvement Scale (GAIS,
Description
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
Time Frame
30 min post injections- 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria 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 willing to abstain from exclusionary procedures in the treatment area (i.e., injectable fillers, laser or chemical resurfacing, botulinum toxin type A, facial cosmetic surgery). Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. 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. Exclusionary Criteria 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. Active infection in the malar area (e.g., acute acne lesions or ulcers). Current history of chronic drug or alcohol abuse. History of autoimmune disease. Current history of blood thinners (aspirin, ibuprofen, naprosyn, herbal supplements, Vitamin E, etc.) Current history of tobacco use Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication. Subjects who anticipate the need for surgery or overnight hospitalization during the study. Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability. Enrollment in any active study involving the use of investigational devices or drugs. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven H Dayan, MD FACS
Organizational Affiliation
DeNova Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
DeNova Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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