Back to resultsAzelaic Acid Versus Hydroquinone in Melasma
Primary Purpose
Melanosis
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
azelaic acid gel
hydroquinone cream
Sponsored by
About this trial
This is an interventional treatment trial for Melanosis focused on measuring melanosis, melasma, azelaic acid, hydroquinone
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
Sites / Locations
- Callender Center for Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Azelaic Acid
Hydroquinone
Arm Description
Outcomes
Primary Outcome Measures
Improvement of melasma
Secondary Outcome Measures
Full Information
NCT ID
NCT00927771
First Posted
June 23, 2009
Last Updated
June 24, 2009
Sponsor
Callender Center for Clinical Research
1. Study Identification
Unique Protocol Identification Number
NCT00927771
Brief Title
Azelaic Acid Versus Hydroquinone in Melasma
Official Title
Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Callender Center for Clinical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanosis
Keywords
melanosis, melasma, azelaic acid, hydroquinone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Azelaic Acid
Arm Type
Experimental
Arm Title
Hydroquinone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
azelaic acid gel
Other Intervention Name(s)
Finacea Gel
Intervention Description
azelaic acid 15% gel twice a day for 6 months
Intervention Type
Drug
Intervention Name(s)
hydroquinone cream
Other Intervention Name(s)
Claripel, Lustra
Intervention Description
hydroquinone 4% cream twice a day for 6 months
Primary Outcome Measure Information:
Title
Improvement of melasma
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy Brooks
Phone
301.249.0970
Email
clinicalresearch@callenderskin.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cherie Young, MD
Phone
301.249.0970
Email
clinicalresearch@callenderskin.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie D Callender, MD
Organizational Affiliation
Howard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Callender Center for Clinical Research
City
Mitchellville
State/Province
Maryland
ZIP/Postal Code
20721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy Brooks
Phone
301-249-0970
Email
clinicalresearch@callenderskin.com
First Name & Middle Initial & Last Name & Degree
Valerie D Callender, MD
First Name & Middle Initial & Last Name & Degree
Cheshana Kindred, MD, MBA
First Name & Middle Initial & Last Name & Degree
Cherie Young, MD
12. IPD Sharing Statement
Links:
URL
http://www.callenderskin.com
Description
Home page to the Callender Skin & Laser Center that includes the link "Research Studies" to the research page
Learn more about this trial
Azelaic Acid Versus Hydroquinone in Melasma
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