Study of Laser Treatment of Melasma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01335581
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : March 26, 2014
Information provided by (Responsible Party):
Cynosure, Inc. ( ConBio, a Cynosure Company )

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

Condition or disease Intervention/treatment Phase
Refractory Mixed Type Melasma Device: Q-Switched Nd:YAG Laser (RevLite) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of the RevLite Q-Switched Nd:YAG Laser System With Smart Infinite (SI) Handpiece for the Treatment of Refractory Mixed Type Melasma
Study Start Date : April 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Experimental: Laser treatment
Laser treatment added to microdermabrasion and topical lightening agent regimen
Device: Q-Switched Nd:YAG Laser (RevLite)
Laser treatment added to a microdermabrasion and topical lightening agent regimen

Primary Outcome Measures :
  1. Melasma Area Severity Assessment (MASI) [ Time Frame: 3 Months ]
    The severity of the melasma is assessed based on a photographic scale.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01335581

United States, New York
New York Laser and Skin Care
New York, New York, United States, 10028
Sponsors and Collaborators
ConBio, a Cynosure Company
Principal Investigator: Arielle Kauvar, MD New York Laser and Skin Care

Responsible Party: ConBio, a Cynosure Company Identifier: NCT01335581     History of Changes
Other Study ID Numbers: C69-10-M
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases