Azelaic Acid Versus Hydroquinone in Melasma

Sponsor

Callender Center for Clinical Research (Other)

Overall Status

Unknown status

CT.gov ID

NCT00927771

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanosis	Drug: azelaic acid gel Drug: hydroquinone cream	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2010

Anticipated Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Azelaic Acid	Drug: azelaic acid gel azelaic acid 15% gel twice a day for 6 months Other Names: Finacea Gel
Active Comparator: Hydroquinone	Drug: hydroquinone cream hydroquinone 4% cream twice a day for 6 months Other Names: Claripel Lustra

Arm

Intervention/Treatment

Experimental: Azelaic Acid

Drug: azelaic acid gel

azelaic acid 15% gel twice a day for 6 months

Other Names:

Finacea Gel

Active Comparator: Hydroquinone

Drug: hydroquinone cream

hydroquinone 4% cream twice a day for 6 months

Other Names:

Claripel

Lustra

Outcome Measures

Primary Outcome Measures

Improvement of melasma [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts 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