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Study of Laser Treatment of Melasma

Primary Purpose

Refractory Mixed Type Melasma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Q-Switched Nd:YAG Laser (RevLite)
Retin-A and microdermabrasion
Sponsored by
ConBio, a Cynosure Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Mixed Type Melasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Laser and Skin Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser treatment

Control

Arm Description

Laser treatment and microdermabrasion and topical lightening agent regimen

Microdermabrasion and topical lightening agent regimen

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 12, 2011
Last Updated
January 5, 2022
Sponsor
ConBio, a Cynosure Company
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1. Study Identification

Unique Protocol Identification Number
NCT01335581
Brief Title
Study of Laser Treatment of Melasma
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 Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ConBio, a Cynosure Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Mixed Type Melasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser treatment
Arm Type
Experimental
Arm Description
Laser treatment and microdermabrasion and topical lightening agent regimen
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Microdermabrasion and topical lightening agent regimen
Intervention Type
Device
Intervention Name(s)
Q-Switched Nd:YAG Laser (RevLite)
Intervention Description
Laser treatment added to a microdermabrasion and topical lightening agent regimen
Intervention Type
Drug
Intervention Name(s)
Retin-A and microdermabrasion
Intervention Description
Microdermabrasion and topical lightening agent regimen
Primary Outcome Measure Information:
Title
Melasma Area Severity Assessment (MASI) Score Change From Baseline to Follow Up
Description
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.
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arielle Kauvar, MD
Organizational Affiliation
New York Laser and Skin Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Laser and Skin Care
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States

12. IPD Sharing Statement

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Study of Laser Treatment of Melasma

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