Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women

• ClinicalTrials.gov Identifier: NCT00616239
• Recruitment Status: Completed
• First Posted: February 15, 2008
• Results First Posted: December 30, 2013
• Last Update Posted: February 7, 2014
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Amit Pandya, University of Texas Southwestern Medical Center

Tracking Information

• First Submitted Date: February 4, 2008
• First Posted Date: February 15, 2008
• Results First Submitted Date: August 26, 2013
• Results First Posted Date: December 30, 2013
• Last Update Posted Date: February 7, 2014
• Study Start Date: January 2008
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 9, 2014)

Number of Participants Showing Improvement of Melasma Based on Mexameter Readings [ Time Frame: 14 weeks ]

The degree of participants pigmentation was measured from the affected and unaffected skin on both sides of the face using a narrowband reflectance spectrophotometer.

• Original Primary Outcome Measures (submitted: February 14, 2008): Improvement of Melasma Based on Mexameter Readings. [ Time Frame: 14 weeks ]
• Current Secondary Outcome Measures (submitted: February 14, 2008): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women
• 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Melasma

Intervention

• 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.
  Other Name: Chemical Peels
• 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
  Other Name: Chemical Peels

Study Arms

• 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.
  Intervention: Drug: 20-30% Salicylic Acid peels to the right side of the face
• 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.
  Intervention: Drug: 20-30% Salicylic Acid peels to the left side of the face

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 14, 2008): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2008
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00616239
• Other Study ID Numbers: 082007-078; IRB File 082007-078
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Amit Pandya, University of Texas Southwestern Medical Center
• Study Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Texas Southwestern Medical Center
• Verification Date: January 2014