Azelaic Acid Versus Hydroquinone in Melasma

Overview[ - collapse ][ - ]

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.
ConditionMelanosis
InterventionDrug: azelaic acid gel
Drug: hydroquinone cream
PhasePhase 4
SponsorCallender Center for Clinical Research
Responsible PartyCallender Center for Clinical Research
ClinicalTrials.gov IdentifierNCT00927771
First ReceivedJune 23, 2009
Last UpdatedJune 24, 2009
Last verifiedJune 2009

Tracking Information[ + expand ][ + ]

First Received DateJune 23, 2009
Last Updated DateJune 24, 2009
Start DateJune 2009
Estimated Primary Completion DateDecember 2010
Current Primary Outcome MeasuresImprovement of melasma [Time Frame: 6 months] [Designated as safety issue: Yes]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleAzelaic Acid Versus Hydroquinone in Melasma
Official TitleEfficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma
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.
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 TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionMelanosis
InterventionDrug: azelaic acid gel
azelaic acid 15% gel twice a day for 6 months
Other Names:
Finacea GelDrug: hydroquinone cream
hydroquinone 4% cream twice a day for 6 months
Other Names:
  • Claripel
  • Lustra
Study Arm (s)
  • Experimental: Azelaic Acid
  • Active Comparator: Hydroquinone

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment30
Estimated Completion DateDecember 2010
Estimated Primary Completion DateJune 2010
Eligibility 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Tracy Brooks
301.249.0970
clinicalresearch@callenderskin.com
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00927771
Other Study ID Numbers09-01-01
Has Data Monitoring CommitteeNo
Information Provided ByCallender Center for Clinical Research
Study SponsorCallender Center for Clinical Research
CollaboratorsNot Provided
Investigators Principal Investigator: Valerie D Callender, MD Howard University
Verification DateJune 2009

Locations[ + expand ][ + ]

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