Azelaic Acid Versus Hydroquinone in Melasma
Information source: Callender Center for Clinical Research
ClinicalTrials.gov processed this data on August 23, 2015 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
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