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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

June 23, 2009
June 24, 2009
June 2009
June 2010   (final data collection date for primary outcome measure)
Improvement of melasma [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00927771 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Azelaic Acid Versus Hydroquinone in Melasma
Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Melanosis
  • Drug: azelaic acid gel
    azelaic acid 15% gel twice a day for 6 months
    Other Name: Finacea Gel
  • Drug: hydroquinone cream
    hydroquinone 4% cream twice a day for 6 months
    Other Names:
    • Claripel
    • Lustra
  • Experimental: Azelaic Acid
    Intervention: Drug: azelaic acid gel
  • Active Comparator: Hydroquinone
    Intervention: Drug: hydroquinone cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 89 Years
No
Contact: Tracy Brooks 301.249.0970 clinicalresearch@callenderskin.com
Contact: Cherie Young, MD 301.249.0970 clinicalresearch@callenderskin.com
United States
 
NCT00927771
09-01-01
No
Valerie D. Callender, MD, Callender Center for Clinical Research
Callender Center for Clinical Research
Not Provided
Principal Investigator: Valerie D Callender, MD Howard University
Callender Center for Clinical Research
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP