Azelaic Acid Versus Hydroquinone in Melasma
Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 23, 2009
CompletedFirst Posted
Study publicly available on registry
June 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJune 25, 2009
June 1, 2009
1 year
June 23, 2009
June 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement of melasma
6 months
Study Arms (2)
Azelaic Acid
EXPERIMENTALHydroquinone
ACTIVE COMPARATORInterventions
azelaic acid 15% gel twice a day for 6 months
hydroquinone 4% cream twice a day for 6 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Callender Center for Clinical Research
Mitchellville, Maryland, 20721, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valerie D Callender, MD
Howard University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 23, 2009
First Posted
June 25, 2009
Study Start
June 1, 2009
Primary Completion
June 1, 2010
Study Completion
December 1, 2010
Last Updated
June 25, 2009
Record last verified: 2009-06