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Study of Laser Treatment of Melasma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc. ( ConBio, a Cynosure Company )
ClinicalTrials.gov Identifier:
NCT01335581
First received: April 12, 2011
Last updated: April 26, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention
Refractory Mixed Type Melasma
 Device: Q-Switched Nd:YAG Laser (RevLite)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Further study details as provided by Cynosure, Inc.:

Primary Outcome Measures:
  • Melasma Area Severity Assessment (MASI) [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    The severity of the melasma is assessed based on a photographic scale.


Enrollment: 18
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335581

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

No publications provided

Responsible Party: Cynosure, Inc. ( ConBio, a Cynosure Company )
ClinicalTrials.gov Identifier: NCT01335581     History of Changes
Other Study ID Numbers: C69-10-M
Study First Received: April 12, 2011
Last Updated: April 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013