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Azelaic Acid Versus Hydroquinone in Melasma

Information source: Callender Center for Clinical Research
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Melanosis

Intervention: azelaic acid gel (Drug); hydroquinone cream (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Callender Center for Clinical Research

Official(s) and/or principal investigator(s):
Valerie D Callender, MD, Principal Investigator, Affiliation: Howard University

Overall contact:
Tracy Brooks, Phone: 301.249.0970, Email: clinicalresearch@callenderskin.com

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.

Clinical Details

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

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

Primary outcome: Improvement 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.

Eligibility

Minimum age: 18 Years. Maximum age: 89 Years. Gender(s): Both.

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

Locations and Contacts

Tracy Brooks, Phone: 301.249.0970, Email: clinicalresearch@callenderskin.com

Callender Center for Clinical Research, Mitchellville, Maryland 20721, United States; Recruiting
Tracy Brooks, Phone: 301-249-0970, Email: clinicalresearch@callenderskin.com
Valerie D Callender, MD, Principal Investigator
Cheshana Kindred, MD, MBA, Sub-Investigator
Cherie Young, MD, Sub-Investigator
Additional Information

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

Starting date: June 2009
Last updated: June 24, 2009

Page last updated: November 27, 2014

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