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

NCT02110134 | Completed

• 1 other identifier: CYN13-REV-TOP-MEL-AK
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Satisfaction Questionnaire

  1 month post last treatment

• Photographic Evaluation using the Global Aesthetic Improvement Scale

  1 month post last treatment

Study Arms (2)

Revlite Laser System with Topical

EXPERIMENTAL

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

Device: Revlite Laser System with hydroquinone skin care regimen

Topical

ACTIVE COMPARATOR

Hydroquinone skin care regimen

Other: Hydroquinone skin care regimen

Interventions

Revlite Laser System with hydroquinone skin care regimen DEVICE

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

Revlite Laser System with Topical

Hydroquinone skin care regimen OTHER

Hydroquinone skin care regimen for the Treatment of Melasma

Topical

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

NY Laser and Skin Care

New York, New York, 10028, United States

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Patricia Krantz

  Cynosure, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: December 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

US (1)