Trial | NCT00927771  Report issue

Title

Azelaic Acid Versus Hydroquinone in Melasma
Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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.
Study Started
Jun 30
2009
Primary Completion
Jun 30
2010
Anticipated
Study Completion
Dec 31
2010
Anticipated
Last Update
Jun 25
2009
Estimate

Drug azelaic acid gel

azelaic acid 15% gel twice a day for 6 months

  • Other names: Finacea Gel

Drug hydroquinone cream

hydroquinone 4% cream twice a day for 6 months

  • Other names: Claripel, Lustra

Azelaic Acid Experimental

Hydroquinone Active Comparator

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
No Results Posted