Azelaic Acid Versus Hydroquinone in Melasma

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2009 by Callender Center for Clinical Research. Recruitment status was Recruiting

First Received on June 23, 2009. Last Updated on June 24, 2009 History of Changes

Sponsor:	Callender Center for Clinical Research
Information provided by:	Callender Center for Clinical Research
ClinicalTrials.gov Identifier:	NCT00927771

Purpose

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	Intervention	Phase
Melanosis	Drug: azelaic acid gel Drug: hydroquinone cream	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma

Resource links provided by NLM:

Drug Information available for: 1,4-Benzenediol Azelaic acid

U.S. FDA Resources

Further study details as provided by Callender Center for Clinical Research:

Primary Outcome Measures:

Improvement of melasma [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	June 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Azelaic Acid	Drug: azelaic acid gel azelaic acid 15% gel twice a day for 6 months Other Name: Finacea Gel
Active Comparator: Hydroquinone	Drug: hydroquinone cream hydroquinone 4% cream twice a day for 6 months Other Names: Claripel Lustra

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

Ages Eligible for Study:	18 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927771

Contacts

Contact: Tracy Brooks	301.249.0970	clinicalresearch@callenderskin.com
Contact: Cherie Young, MD	301.249.0970	clinicalresearch@callenderskin.com

Locations

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

Sponsors and Collaborators

Callender Center for Clinical Research

Investigators

Principal Investigator:

Valerie D Callender, MD

Howard University

More Information

Additional Information:

Home page to the Callender Skin & Laser Center that includes the link "Research Studies" to the research page This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Valerie D. Callender, MD, Callender Center for Clinical Research
ClinicalTrials.gov Identifier:	NCT00927771 History of Changes
Other Study ID Numbers:	09-01-01
Study First Received:	June 23, 2009
Last Updated:	June 24, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Callender Center for Clinical Research:

melanosis
melasma
azelaic acid
hydroquinone

Additional relevant MeSH terms:

Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Hydroquinone
Azelaic acid
Radiation-Protective Agents
Protective Agents

Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012