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

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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