Study of Laser Treatment of Melasma

Brief Summary

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”

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

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: March 2012

Interventions Used in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Laser treatment
    • Laser treatment added to microdermabrasion and topical lightening agent regimen

Outcome Measures for this Clinical Trial

Primary Measures

  • Melasma Area Severity Assessment (MASI)
    • Time Frame: 3 Months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • ConBio, a Cynosure Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Arielle Kauvar, MD, Principal Investigator, New York Laser and Skin Care

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01335581