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OpenTrials
Completed

NCT Number: NCT01335581

Study of Laser Treatment of Melasma

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Laser and Skin Care

New York, 10028, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Q-Switched Nd:YAG Laser (RevLite)

Device

Laser treatment added to a microdermabrasion and topical lightening agent regimen

Retin-A and microdermabrasion

Drug

Microdermabrasion and topical lightening agent regimen

Primary outcomes

  1. Melasma Area Severity Assessment (MASI) Score Change From Baseline to Follow Up

    Time frame: 3 Months

    The severity of the melasma is assessed based on a photographic scale. The scale ranges from 0 to 48, with 48 being the most severe. A decrease in the MASI score from the baseline to the follow up corresponds with decreasing severity.

Sponsors and collaborators

Lead sponsor

ConBio, a Cynosure Company

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 14, 2011
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.