Azelaic Acid Versus Hydroquinone in Melasma

Phase 4

• Conditions: Melanosis
• Interventions: Drug: azelaic acid gel; Drug: hydroquinone cream

• Registration Number: NCT00927771
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2009-06
• Study Start: 2009-06
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-24
• Last Update Submitted: 2009-06-24
• Study First Posted: 2009-06-25
• Last Update Posted: 2009-06-25
• Primary Completion: 2010-06
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Azelaic Acid	azelaic acid gel	-
Hydroquinone	hydroquinone cream	-

Primary Outcome Measures

Name	Time	Method
Improvement of melasma	6 months

Trial Locations

Locations (1)

Callender Center for Clinical Research; 🇺🇸 Mitchellville, Maryland, United States