Study of Laser Treatment of Melasma

NCT01335581 | Completed Results

• 1 other identifier: C69-10-M
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Refractory Mixed Type Melasma

Outcome Measures

Primary Outcomes (1)

• 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.

  3 Months

Study Arms (2)

Laser treatment

EXPERIMENTAL

Laser treatment and microdermabrasion and topical lightening agent regimen

Device: Q-Switched Nd:YAG Laser (RevLite); Drug: Retin-A and microdermabrasion

Control

ACTIVE COMPARATOR

Microdermabrasion and topical lightening agent regimen

Drug: Retin-A and microdermabrasion

Interventions

Q-Switched Nd:YAG Laser (RevLite) DEVICE

Laser treatment added to a microdermabrasion and topical lightening agent regimen

Laser treatment

Retin-A and microdermabrasion DRUG

Microdermabrasion and topical lightening agent regimen

Control; Laser treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ConBio, a Cynosure Company: lead

Study Sites (1)

New York Laser and Skin Care

New York, New York, 10028, United States

Location

MeSH Terms

Interventions

Tretinoin

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Jamie Trimper
• Organization: Cynosure

jamie.trimper@cynosure.com

800-886-2966

Study Officials

• Arielle Kauvar, MD

  New York Laser and Skin Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 14, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 13, 2022
• Results First Posted: December 28, 2020

Record last verified: 2022-01

Locations

US (1)