Azelaic Acid Versus Hydroquinone in Melasma
Overview[ - collapse ][ - ]
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. |
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Condition | Melanosis |
Intervention | Drug: azelaic acid gel Drug: hydroquinone cream |
Phase | Phase 4 |
Sponsor | Callender Center for Clinical Research |
Responsible Party | Callender Center for Clinical Research |
ClinicalTrials.gov Identifier | NCT00927771 |
First Received | June 23, 2009 |
Last Updated | June 24, 2009 |
Last verified | June 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | June 23, 2009 |
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Last Updated Date | June 24, 2009 |
Start Date | June 2009 |
Estimated Primary Completion Date | December 2010 |
Current Primary Outcome Measures | Improvement of melasma [Time Frame: 6 months] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Azelaic Acid Versus Hydroquinone in Melasma |
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Official Title | Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma |
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. |
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. |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Melanosis |
Intervention | Drug: azelaic acid gel azelaic acid 15% gel twice a day for 6 months Other Names: Finacea GelDrug: hydroquinone cream hydroquinone 4% cream twice a day for 6 months Other Names:
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Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 30 |
Estimated Completion Date | December 2010 |
Estimated Primary Completion Date | June 2010 |
Eligibility 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Tracy Brooks 301.249.0970 clinicalresearch@callenderskin.com |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00927771 |
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Other Study ID Numbers | 09-01-01 |
Has Data Monitoring Committee | No |
Information Provided By | Callender Center for Clinical Research |
Study Sponsor | Callender Center for Clinical Research |
Collaborators | Not Provided |
Investigators | Principal Investigator: Valerie D Callender, MD Howard University |
Verification Date | June 2009 |
Locations[ + expand ][ + ]
Callender Center for Clinical Research | Mitchellville, Maryland, United States, 20721 Contact: Tracy Brooks | 301-249-0970 | clinicalresearch@callenderskin.comPrincipal Investigator: Valerie D Callender, MD Recruiting |
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