Azelaic Acid Versus Hydroquinone in Melasma

NCT ID: NCT00927771

Last Updated: 2009-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-12-31

Brief Summary

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The purpose of this study is to compare the safety and effectiveness of Azelaic Acid Gel to Hydroquinone Cream in the treatment of melasma.

Detailed Description

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Melasma is a chronic condition in which dark areas appear on the forehead, cheeks, and upper lips. Hydroquinone is a skin lightener (or fade cream) and is one of the most commonly used medications for the treatment of melasma. Azelaic acid gel is currently used to treat acne and rosacea.

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

DOUBLE

Participants Investigators

Study Groups

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Azelaic Acid

Group Type EXPERIMENTAL

azelaic acid gel

Intervention Type DRUG

azelaic acid 15% gel twice a day for 6 months

Hydroquinone

Group Type ACTIVE_COMPARATOR

hydroquinone cream

Intervention Type DRUG

hydroquinone 4% cream twice a day for 6 months

Interventions

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azelaic acid gel

azelaic acid 15% gel twice a day for 6 months

Intervention Type DRUG

hydroquinone cream

hydroquinone 4% cream twice a day for 6 months

Intervention Type DRUG

Other Intervention Names

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Finacea Gel Claripel Lustra

Eligibility Criteria

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Inclusion Criteria

* must have stable moderate-severe epidermal or mixed melasma involving the face
* all races
* males and females
* persons taking birth control medication, hormone replacement therapy or any other hormone altering medication may participate only if they have not started or stopped the medication within the last 3 months

Exclusion Criteria

* if the person has only dermal melasma
* pregnancy, breastfeeding, a positive pregnancy test in the office or plans to become pregnant
* a known allergy or sensitivity ot azelaic acid or hydroquinone
* the use of photosensitizing medications (ex. tetracycline) within 3 months of the study.
* starting or stopping hormonal medication within 3 months
* chemical peels, microdermabrasion, or laser treatment within 6 months
* worsening or improving melasma
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Callender Center for Clinical Research

OTHER

Sponsor Role lead

Responsible Party

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Callender Center for Clinical Research

Principal Investigators

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Valerie D Callender, MD

Role: PRINCIPAL_INVESTIGATOR

Howard University

Locations

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Callender Center for Clinical Research

Mitchellville, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tracy Brooks

Role: CONTACT

301.249.0970

Cherie Young, MD

Role: CONTACT

301.249.0970

Facility Contacts

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Tracy Brooks

Role: primary

301-249-0970

Other Identifiers

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09-01-01

Identifier Type: -

Identifier Source: org_study_id

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