A Study of Nutritional Supplementation in Altering Ecchymosis, Erythema and Health Outcomes Associated With Aesthetic Procedures
Status: | Completed |
---|---|
Conditions: | Hematology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery, Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/3/2018 |
Start Date: | July 2013 |
End Date: | October 2015 |
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
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.
bruising following facial ablative laser resurfacing treatments and following soft tissue
filler injections to the lips and/or malar areas.
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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