Study of Laser Treatment of Melasma

NCT ID: NCT01335581

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-03-31

Brief Summary

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

Conditions

Refractory Mixed Type Melasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser treatment

Laser treatment and microdermabrasion and topical lightening agent regimen

Group Type: EXPERIMENTAL

Q-Switched Nd:YAG Laser (RevLite)

Intervention Type: DEVICE

Laser treatment added to a microdermabrasion and topical lightening agent regimen

Retin-A and microdermabrasion

Intervention Type: DRUG

Microdermabrasion and topical lightening agent regimen

Control

Microdermabrasion and topical lightening agent regimen

Group Type: ACTIVE_COMPARATOR

Retin-A and microdermabrasion

Intervention Type: DRUG

Microdermabrasion and topical lightening agent regimen

Interventions

Q-Switched Nd:YAG Laser (RevLite)

Laser treatment added to a microdermabrasion and topical lightening agent regimen

Intervention Type: DEVICE

Retin-A and microdermabrasion

Microdermabrasion and topical lightening agent regimen

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ConBio, a Cynosure Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arielle Kauvar, MD

Role: PRINCIPAL_INVESTIGATOR

New York Laser and Skin Care

Locations

New York Laser and Skin Care

New York, New York, United States

Countries

United States

Other Identifiers

C69-10-M

Identifier Type: -

Identifier Source: org_study_id