Recruiting

Azelaic Acid vs. Hydroquinone

Sponsor:

Callender Center for Clinical Research

Code:

NCT00927771

Conditions

Melanosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

azelaic acid gel

hydroquinone cream

Study Details

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.

Conditions

Melanosis

Study ID

NCT00927771

Start date

Jun, 2009

Status verified date

Jun, 2009

Completion date

Dec, 2010

Anticipated

Primary completion date

Jun, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Azelaic Acid

active comparator: Hydroquinone

Interventions

azelaic acid gel

azelaic acid 15% gel twice a day for 6 months

hydroquinone cream

hydroquinone 4% cream twice a day for 6 months

Primary outcome measure

  • Improvement of melasma [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Tracy Brooks

301.249.0970clinicalresearch@callenderskin.com

Cherie Young, MD

301.249.0970clinicalresearch@callenderskin.com

Locations

Callender Center for Clinical Research

Recruiting

Mitchellville, Maryland, United States, 20721

Contacts

Tracy Brooks

301-249-0970clinicalresearch@callenderskin.com

Principal Investigator:

Valerie D Callender, MD

More Information

Sponsor

Callender Center for Clinical Research

Last update posted

Jun 25, 2009

Last verified

Jun, 2009

Keywords

  • melanosis
  • melasma
  • azelaic acid
  • hydroquinone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Callender Center for Clinical Research on 2009-06-25.