Melasma
Conditions
Brief summary
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
Interventions
DEVICERevlite Q switched Nd:YAG
Revlite Q switched Nd:YAG 1064nm
DEVICETrivantage Q switched Nd: YAG
Trivantage Q switched Nd: YAG 1064nm
Sponsors
Cynosure, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
This was a comparative study where the device was used outside of the recommended treatment usage. It was used to assess the Revlite device for feasibility and not health outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Melasma Determined by Physician | 3 months post last treatment | The Global Aesthetic Improvement scale was used to determine the amount of improvement. This scale ranges from 1 to 5, where 1 is very much improved, 2 is much improved, 3 is improved, 4 is no change, and 5 is worsened. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Universal Pain Scale for Subject Tolerability | 3 months post last treatment | The subject pain tolerability was assessed using the Universal Pain Scale. This scale ranges from 0 (no pain) to 10 (worst pain possible). |
Countries
United States
Outcome results
None listed