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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00616239
First Posted: February 15, 2008
Last Update Posted: February 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amit Pandya, University of Texas Southwestern Medical Center
February 4, 2008
February 15, 2008
August 26, 2013
December 30, 2013
February 7, 2014
January 2008
June 2008   (Final data collection date for primary outcome measure)
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.
Improvement of Melasma Based on Mexameter Readings. [ Time Frame: 14 weeks ]
Complete list of historical versions of study NCT00616239 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Melasma
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00616239
082007-078
IRB File 082007-078
No
Not Provided
Not Provided
Amit Pandya, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Amit Pandya, M.D. UT Southwestern Medical Center at Dallas - Department of Dermatology
University of Texas Southwestern Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP