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Azelaic Acid Versus Hydroquinone in Melasma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Callender Center for Clinical Research.
Recruitment status was:  Recruiting
Information provided by:
Callender Center for Clinical Research Identifier:
First received: June 23, 2009
Last updated: June 24, 2009
Last verified: June 2009
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 Intervention Phase
Melanosis Drug: azelaic acid gel Drug: hydroquinone cream Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Callender Center for Clinical Research:

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

Estimated Enrollment: 30
Study Start Date: June 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00927771

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

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
Principal Investigator: Valerie D Callender, MD Howard University
  More Information

Additional Information:
Responsible Party: Valerie D. Callender, MD, Callender Center for Clinical Research Identifier: NCT00927771     History of Changes
Other Study ID Numbers: 09-01-01
Study First Received: June 23, 2009
Last Updated: June 24, 2009

Keywords provided by Callender Center for Clinical Research:
azelaic acid

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents processed this record on September 21, 2017