Study of Laser Treatment of Melasma

January 5, 2022 updated by: ConBio, a Cynosure Company

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10028
        • New York Laser and Skin Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser treatment
Laser treatment and microdermabrasion and topical lightening agent regimen
Device: Q-Switched Nd:YAG Laser (RevLite)
Laser treatment added to a microdermabrasion and topical lightening agent regimen
Drug: Retin-A and microdermabrasion
Microdermabrasion and topical lightening agent regimen
Active Comparator: Control
Microdermabrasion and topical lightening agent regimen
Drug: Retin-A and microdermabrasion
Microdermabrasion and topical lightening agent regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ConBio, a Cynosure Company

Investigators

  • Principal Investigator: Arielle Kauvar, MD, New York Laser and Skin Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

April 13, 2011

First Posted (Estimate)

April 14, 2011

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C69-10-M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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