Official Title: “The Efficacy of Salicylic Acid Peels Combined With 4% Hydroquinone Cream Versus 4% Hydroquinone Cream Alone in the Treatment of Hispanic Women With Moderate to Severe Melasma”

This study will enroll 20 adult Hispanic women. Participants will apply 4% hydroquinone cream twice daily to affected areas on the face for 14 weeks and half the face will be peeled with 20-30% salicylic acid every two weeks for a total of 4 peels. The first two peels will be 20% salicylic acid and the second two peels will be with 30% salicylic acid. The purpose of the study will be to evaluate the safety and efficacy of salicylic acid combined with 4% hydroquinone versus 4% hydroquinone alone.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: 20-30% Salicylic Acid peels to the right side of the face
  • Two 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the right side of the face.
• Drug: 20-30% Salicylic Acid peels to the left side of the face
  • Two 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the left side of the face

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
• Active Comparator: B
  • Subjects randomized to have the left side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.

Primary Measures

• Improvement of melasma based on mexameter readings.
  • Time Frame: 14 weeks
    Safety Issue?: No

Secondary Measures

• Improvement of melasma based on MASI scores, melasma severity assessment, and physician and patient global improvement compared with the opposite side.
  • Time Frame: 14 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Hispanic women ages 18-65 years of age with moderate to severe melasma
• English and Spanish-speaking women

Exclusion Criteria:

• Pregnant or breast-feeding women
• Subjects who have used 4% hydroquinone within 3 months of study start
• Subjects who have used chemical peels, microdermabrasion or facial laser treatments within 9 months of study start

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Texas Southwestern Medical Center

Overall Clinical Trial Officials and Contacts

Amit Pandya, M.D. Principal Investigator UT Southwestern Medical Center at Dallas - Department of Dermatology  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00616239

Study ID Number: 082007-078

ClinicalTrials.gov Identifier: NCT00616239

Health Authority: United States: Institutional Review Board