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

Primary Purpose

Melasma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Revlite Laser System with hydroquinone skin care regimen

Hydroquinone skin care regimen

About this trial

This is an interventional device feasibility trial for Melasma

Eligibility Criteria

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

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

Sites / Locations

NY Laser and Skin Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Revlite Laser System with Topical

Topical

Arm Description

Revlite Laser System for the Treatment of Melasma and hydroquinone skin care regimen

Hydroquinone skin care regimen

Outcomes

Primary Outcome Measures

Rates of Adverse Events Among Patients

Adverse events were collected and reported to test the safety and efficacy of the device.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02110134

First Posted

April 8, 2014

Last Updated

November 16, 2020

Sponsor

Cynosure, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02110134

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cynosure, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melasma

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Revlite Laser System with Topical

Arm Type

Experimental

Arm Description

Revlite Laser System for the Treatment of Melasma and hydroquinone skin care regimen

Arm Title

Topical

Arm Type

Active Comparator

Arm Description

Hydroquinone skin care regimen

Intervention Type

Device

Intervention Name(s)

Revlite Laser System with hydroquinone skin care regimen

Intervention Description

Revlite Laser System with hydroquinone skin care regimen for the Treatment of Melasma

Intervention Type

Other

Intervention Name(s)

Hydroquinone skin care regimen

Intervention Description

Hydroquinone skin care regimen for the Treatment of Melasma

Primary Outcome Measure Information:

Title

Rates of Adverse Events Among Patients

Description

Adverse events were collected and reported to test the safety and efficacy of the device.

Time Frame

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 Measure Information:

Title

Satisfaction Questionnaire

Description

Physician and subject satisfaction will be ranked on a scale from 1 to 5, where 1 is extremely dissatisfied and 6 is extremely satisfied.

Time Frame

1 month post last treatment

Title

Photographic Evaluation using the Global Aesthetic Improvement Scale

Description

Time Frame

1 month post last treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patricia Krantz

Organizational Affiliation

Cynosure, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

NY Laser and Skin Care

City

New York

State/Province

New York

ZIP/Postal Code

10028

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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