A Pilot Study Testing 1064nm Q-switch Laser Versus Glycolic Acid Peels for the Treatment of Melasma

NCT01976273 | Completed Results DMC

• 1 other identifier: STU84150
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out the safety and effectiveness of 1064 Q-Switch Laser Therapy compared to Glycolic Acid Chemical Peels for the treatment of melasma.

Conditions

Melanosis

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10

  The primary outcome was a blinded rating of improvement of the treatment area (1064nm Q-switch Laser Versus Glycolic Acid Peels) using a Visual Analog Scale (VAS). A dermatologist blindly evaluated the treated areas of each side from live subjects at baseline on the final follow up visit (week 10). The VAS of improvement was rated on a scale of 0 to10, with 0 being no improvement and 10 being the most improvement seen by the treatment.

  Week 10

Study Arms (2)

1064nm Q-switch Laser

ACTIVE COMPARATOR

The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.

Device: 1064nm Q-switch Laser

Glycolic Acid Peels

ACTIVE COMPARATOR

A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin's outermost layer.

Other: Glycolic Acid Peels

Interventions

1064nm Q-switch Laser DEVICE

1064nm Q-switch Laser

Glycolic Acid Peels OTHER

Glycolic Acid Peels

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 18 years or older
• Subjects with at least a 2 x 2 cm patch of melasma on each side of the face (forehead or cheek)
• Subjects in general good health
• Subjects must be willing and able to understand and provide informed consent for the use of their tissue and communicate with the investigator
• Subjects must be willing to not apply other treatment options for melasma during the course of the study

You may not qualify if:

• Subjects under 18 years of age
• Subjects who are pregnant and/or lactating
• Subjects who are unable to understand the protocol or to give informed consent
• Subjects diagnosed with mental illness
• Subjects who have concurrent active uncontrolled disease to facial area (i.e uncontrolled acne)
• Subjects who have had a chemical peel in the past 3 months
• Subjects who have used a prescribed retinoid in the past 3 months
• Subjects with a bleeding disorder
• Subjects with a history of abnormal wound healing
• Subjects with a history of abnormal scarring
• Subjects who report being allergic to glycolic acid

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Murad Alam
• Organization: Northwestern University

m-alam@northwestern.edu

312-695-4761

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: November 5, 2013
• Study Start: October 1, 2013
• Primary Completion: January 7, 2015
• Study Completion: January 7, 2015
• Last Updated: December 6, 2021
• Results First Posted: June 14, 2017

Record last verified: 2021-12

Locations

US (1)