Study of Laser Treatment of Melasma

Cynosure

Status: Completed

Conditions: Refractory Mixed Type Melasma

Treatments: Drug: Retin-A and microdermabrasion; Device: Q-Switched Nd:YAG Laser (RevLite)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01335581

C69-10-M

Details and patient eligibility

About

The purpose of this study is to evaluate the RevLite laser in the treatment of refractory mixed type melasma.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fitzpatrick Skin Type III-VI
• mixed (epidermal and dermal) melasma diagnosed by Wood's Lamp exam
• age 18 or older
• melasma persisting for greater than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents
• written and verbal informed consent
• willing and able to comply with study instructions and return to the clinic for required visits

Exclusion criteria

• Pregnancy, breastfeeding, taking birth control pills or plans to become pregnant during the study
• history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis
• any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy
• uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
• any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study
• currently enrolled in an investigational drug or device trial, or has received an investigational drug or has been treated with an investigational device within 30 days prior to entering this study
• inability to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
• unreliability for the study (this includes subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits)
• use of photosensitizing drugs within a timeframe where photosensitization from these drugs may still be present
• need to be exposed to artificial tanning devices or excessive sunlight during the trial
• Diabetes Type I or II
• sensitivity to hydroquinone or Retin-A
• evidence of a compromised immune system or hepatitis
• use of bleaching creams or retinoids within the last 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Laser treatment

Experimental group

Description:

Laser treatment and microdermabrasion and topical lightening agent regimen

Treatment:

Device: Q-Switched Nd:YAG Laser (RevLite)

Drug: Retin-A and microdermabrasion

Control

Active Comparator group

Description:

Microdermabrasion and topical lightening agent regimen

Treatment:

Drug: Retin-A and microdermabrasion