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

Completed · Not applicable · Has a placebo group

Conditions studied: Ecchymosis and Erythema Commonly Associated With Soft Tissue Filler Injections

In brief

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.

Key facts

Study ID

NCT01919359

Run by

DeNova Research

People needed

108

Starts

2013-07-01

Expected to finish

2015-10-01

Last updated by the study team

2018-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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 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.

Where it is running

• DeNova Research — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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