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Azelaic Acid Versus Hydroquinone in Melasma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Callender Center for Clinical Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Callender Center for Clinical Research
ClinicalTrials.gov Identifier:
NCT00927771
First received: June 23, 2009
Last updated: June 24, 2009
Last verified: June 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Improvement of melasma [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927771

Contacts
Contact: Tracy Brooks 301.249.0970 clinicalresearch@callenderskin.com
Contact: Cherie Young, MD 301.249.0970 clinicalresearch@callenderskin.com

Locations
United States, Maryland
Callender Center for Clinical Research Recruiting
Mitchellville, Maryland, United States, 20721
Contact: Tracy Brooks     301-249-0970     clinicalresearch@callenderskin.com    
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
Investigators
Principal Investigator: Valerie D Callender, MD Howard University
  More Information

Additional Information:
Home page to the Callender Skin & Laser Center that includes the link "Research Studies" to the research page  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Valerie D. Callender, MD, Callender Center for Clinical Research
ClinicalTrials.gov Identifier: NCT00927771     History of Changes
Other Study ID Numbers: 09-01-01
Study First Received: June 23, 2009
Last Updated: June 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Callender Center for Clinical Research:
melanosis
melasma
azelaic acid
hydroquinone

Additional relevant MeSH terms:
Hyperpigmentation
Melanosis
Pigmentation Disorders
Skin Diseases
Hydroquinone
Azelaic acid
Radiation-Protective Agents
Protective Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013