Revlite Laser System Compared to the Candela Alex TriVantage System Refractory Mixed Type Melasma



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/1/2014
Start Date:July 2012
End Date:July 2013
Contact:Kauvar Nurses
Phone:212-249-9440

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This proof of concept study will be conducted to assess the aesthetic improvement in
refractory mixed type melasma in subjects treated with two FDA 510K approved devices: Q
Switched Nd: YAG Laser vs. Alex TriVantage


Inclusion Criteria:

1. Subjects with Fitzpatrick Skin Type III-VI

2. Subjects with mixed (epidermal and dermal) type melasma diagnosed by Wood's Lamp.

3. Subjects who are over the age of 18 years of age

4. The subject is willing and able to comply with study instructions and return to the
clinic for required visits.

5. The subject's melasma has persisted for greater than 6 months and has failed to
respond to conventional treatment with hydroquinone cream or other topical lightening
agents.

Exclusion Criteria:

1. The subject is female and pregnant, has been pregnant within the last 3 months, is
currently breast feeding or planning a pregnancy during the study period.

2. The subject has a history of cutaneous photosensitization, porphyria, and
hypersensitivity to porphyrins or photodermatosis.

3. The subject has any skin pathology or condition that could interfere with the
evaluation or requires the use of interfering topical or systemic therapy.

4. The subject has an uncorrected coagulation defect or is currently using
anti-coagulation medication (including but not limited to heavy aspirin therapy).

5. The subject has any condition which, in the investigator's opinion, would make it
unsafe for the subject to participate in this research study.

6. The subject is currently enrolled in an investigational drug or device trial, or has
received an investigational drug or been treated with an investigational device
within 30 days prior to entering this study.

7. The subject has used photosensitizing drugs (e.g., Declomycin, sulfa antibiotics,
phenothiazines, etc.) within a timeframe where photosensitization from these drugs
may still be present.

8. The subject has the need to be exposed to artificial tanning devices or excessive
sunlight during the trial.

9. The subject has had prior treatment with parenteral gold therapy (gold sodium
thiomalate).

10. The subject has Diabetes Type 1 or 2.

11. The subject has a sensitivity to hydroquinone or Retin-A.

12. The subject has evidence of a compromised immune system or hepatitis.

13. Has had microdermabrasion in past 3 months, other laser or Intense Pulsed Light
treatment or chemical peels to the face in past 6 months, injectable fillers, topical
retinoids, over-the-counter anti-aging products past 2 weeks.

14. Has a history of keloids or hypertrophic scarring

15. Has permanent make-up and/or is unwilling to refrain from using semi-permanent
cosmetics during study
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