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Azelaic Acid Versus Hydroquinone in Melasma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00927771
Recruitment Status : Unknown
Verified June 2009 by Callender Center for Clinical Research.
Recruitment status was:  Recruiting
First Posted : June 25, 2009
Last Update Posted : June 25, 2009
Information provided by:
Callender Center for Clinical Research

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

Condition or disease Intervention/treatment Phase
Melanosis Drug: azelaic acid gel Drug: hydroquinone cream Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma
Study Start Date : June 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Azelaic Acid Drug: azelaic acid gel
azelaic acid 15% gel twice a day for 6 months
Other Name: Finacea Gel

Active Comparator: Hydroquinone Drug: hydroquinone cream
hydroquinone 4% cream twice a day for 6 months
Other Names:
  • Claripel
  • Lustra

Primary Outcome Measures :
  1. Improvement of melasma [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00927771

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Contact: Tracy Brooks 301.249.0970
Contact: Cherie Young, MD 301.249.0970

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United States, Maryland
Callender Center for Clinical Research Recruiting
Mitchellville, Maryland, United States, 20721
Contact: Tracy Brooks    301-249-0970   
Principal Investigator: Valerie D Callender, MD         
Sub-Investigator: Cheshana Kindred, MD, MBA         
Sub-Investigator: Cherie Young, MD         
Sponsors and Collaborators
Callender Center for Clinical Research
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Principal Investigator: Valerie D Callender, MD Howard University

Additional Information:
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Responsible Party: Valerie D. Callender, MD, Callender Center for Clinical Research Identifier: NCT00927771     History of Changes
Other Study ID Numbers: 09-01-01
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: June 25, 2009
Last Verified: June 2009
Keywords provided by Callender Center for Clinical Research:
azelaic acid
Additional relevant MeSH terms:
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Pigmentation Disorders
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents