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

NCT ID: NCT01976273

Last Updated: 2021-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-01-07

Brief Summary

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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.

Detailed Description

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Participants in this study will be patients at the dermatology clinic who are clinically diagnosed with at least a 2X2 cm patch of melasma on each side of their face (forehead or cheek). Starting at 2 weeks before treatment (week 2), both sides will be pretreated and primed with 4% hydroquinone with, if necessary, 2.5% hydrocortisone cream BID. On the treatment day (2-weeks) and 6-weeks one half of the subject's face will receive glycolic acid peels and the other half of the face will receive 1064nm Q-switch laser. This study is a pilot study designed to determine feasibility of these procedures.

Conditions

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Melanosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1064nm Q-switch Laser

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

Group Type ACTIVE_COMPARATOR

1064nm Q-switch Laser

Intervention Type DEVICE

Glycolic Acid Peels

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.

Group Type ACTIVE_COMPARATOR

Glycolic Acid Peels

Intervention Type OTHER

Interventions

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1064nm Q-switch Laser

Intervention Type DEVICE

Glycolic Acid Peels

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU84150

Identifier Type: -

Identifier Source: org_study_id