Azelaic Acid Versus Hydroquinone in Melasma

Melanosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00927771
• Other study ID #: 09-01-01
• Status: Recruiting
• Phase: Phase 4
• First received: June 23, 2009
• Last updated: June 24, 2009
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2009
• Source: Callender Center for Clinical Research
• Contact: Tracy Brooks
• Phone: 301.249.0970
• Email: clinicalresearch[@]callenderskin.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanosis

Intervention

Drug:
• azelaic acid gel
azelaic acid 15% gel twice a day for 6 months
• hydroquinone cream
hydroquinone 4% cream twice a day for 6 months

Locations

Country	Name	City	State
United States	Callender Center for Clinical Research	Mitchellville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Callender Center for Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of melasma		6 months	Yes

External Links

•   Home page to the Callender Skin & Laser Center that includes the link "Research Studies" to the research page