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

NCT ID: NCT01919359

Last Updated: 2018-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

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

Group Type: EXPERIMENTAL

Multizyme Cellular Vitality Cyruta Plus SHEP

Intervention Type: DIETARY_SUPPLEMENT

Soft Tissue filler sugar pill

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

Group Type: PLACEBO_COMPARATOR

Multizyme Cellular Vitality Cyruta Plus SHEP

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Multizyme Cellular Vitality Cyruta Plus SHEP

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Standard Process Inc.

INDUSTRY

Sponsor Role: collaborator

DeNova Research

OTHER

Sponsor Role: lead

Responsible Party

Steven H. Dayan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven H Dayan, MD FACS

Role: PRINCIPAL_INVESTIGATOR

DeNova Research

Locations

DeNova Research

Chicago, Illinois, United States

Countries

United States

Other Identifiers

PS-SUP-12

Identifier Type: -

Identifier Source: org_study_id