Azelaic Acid Versus Hydroquinone in Melasma

June 24, 2009 updated by: Callender Center for Clinical Research

Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma

The purpose of this study is to compare the safety and effectiveness of Azelaic Acid Gel to Hydroquinone Cream in the treatment of melasma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Mitchellville, Maryland, United States, 20721
        • Recruiting
        • Callender Center For Clinical Research
        • Contact:
        • Principal Investigator:
          • Valerie D Callender, MD
        • Sub-Investigator:
          • Cheshana Kindred, MD, MBA
        • Sub-Investigator:
          • Cherie Young, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Azelaic Acid
Drug: azelaic acid gel
azelaic acid 15% gel twice a day for 6 months
Other Names:
  • Finacea Gel
Active Comparator: Hydroquinone
Drug: hydroquinone cream
hydroquinone 4% cream twice a day for 6 months
Other Names:
  • Claripel
  • Lustra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of melasma
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Callender Center for Clinical Research

Investigators

  • Principal Investigator: Valerie D Callender, MD, Howard University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimate)

June 25, 2009

Study Record Updates

Last Update Posted (Estimate)

June 25, 2009

Last Update Submitted That Met QC Criteria

June 24, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-01-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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