A Study of the RevLite Laser System for the Treatment of Refractory Mixed Type Melasma

The purpose of this study is to compare a hydroquinone skin care regimen alone to a combination of Revlite Laser treatment with a hydroquinone skin care regimen for the treatment of melasma.

Study Overview

• Status: Completed
• Conditions: Melasma
• Intervention / Treatment: Device: Revlite Laser System with hydroquinone skin care regimen; Other: Hydroquinone skin care regimen

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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:

• Subjects with Fitzpatrick Skin Type III-VI
• Subjects with mixed (epidermal and dermal) type melasma diagnosed by Wood's Lamp.
• Subjects who are over the age of 18 years of age
• The subject is willing and able to comply with study instructions and return to the clinic for required visits.
• The subject's melasma has persisted for greater than 6 months

Exclusion Criteria:

• The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
• The subject has a history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis.
• The subject has any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy.
• The subject has an uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy).
• The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
• The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days prior to entering this study.
• The subject has used photosensitizing drugs (e.g., Declomycin, sulfa antibiotics, phenothiazines, etc.) within a timeframe where photosensitization from these drugs may still be present.
• The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
• The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
• The subject has Diabetes Type 1 or 2.
• The subject has a sensitivity to hydroquinone or Retin-A.
• The subject has evidence of a compromised immune system or hepatitis.
• Has had microdermabrasion in past 3 months, other laser or Intense Pulsed Light treatment or chemical peels to the face in past 6 months, injectable fillers, topical retinoids, over-the-counter anti-aging products past 2 weeks.
• Has a history of keloids or hypertrophic scarring
• Has permanent make-up and/or is unwilling to refrain from using semi-permanent cosmetics during study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Revlite Laser System with Topical; Revlite Laser System for the Treatment of Melasma and hydroquinone skin care regimen	Device: Revlite Laser System with hydroquinone skin care regimen; Revlite Laser System with hydroquinone skin care regimen for the Treatment of Melasma
Active Comparator: Topical; Hydroquinone skin care regimen	Other: Hydroquinone skin care regimen; Hydroquinone skin care regimen for the Treatment of Melasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of Adverse Events Among Patients	Adverse events were collected and reported to test the safety and efficacy of the device.	From study baseline to completion, approximately 1 year. However, adverse events not resolved by then will be followed up with until they are resolved.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction Questionnaire	Physician and subject satisfaction will be ranked on a scale from 1 to 5, where 1 is extremely dissatisfied and 6 is extremely satisfied.	1 month post last treatment
Photographic Evaluation using the Global Aesthetic Improvement Scale	Photos will be a taken at baseline and post treatment and then improvement assessed using the Global Aesthetic Improvement Scale. This scale ranges from 0 to 3, where 0 is 0-25% clearance from baseline photograph, 1 is 25-50% clearance from baseline photograph, 2 is 50-75% clearance from baseline photograph, and 3 is 75-100% clearance from baseline photograph.	1 month post last treatment

Collaborators and Investigators

• Sponsor: Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Radiation-Protective Agents; Hydroquinone
• Other Study ID Numbers: CYN13-REV-TOP-MEL-AK