Azelaic Acid Versus Hydroquinone in Melasma

Callender Center for Clinical Research

Status and phase

Unknown

Phase 4

Conditions

Melanosis

Treatments

Drug: azelaic acid gel

Drug: hydroquinone cream

Study type

Interventional

Funder types

Other

Identifiers

NCT00927771

09-01-01

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

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