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Azelaic Acid Versus Hydroquinone in Melasma

Phase 4
Conditions
Melanosis
Interventions
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.

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
GroupInterventionDescription
Azelaic Acidazelaic acid gel-
Hydroquinonehydroquinone cream-
Primary Outcome Measures
NameTimeMethod
Improvement of melasma6 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Callender Center for Clinical Research

🇺🇸

Mitchellville, Maryland, United States

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