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Phase 4 N=20 Randomized Single-blind Treatment

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

Melasma

Bottom Line

View on ClinicalTrials.gov: NCT00616239 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Number of Participants Showing Improvement of Melasma Based on Mexameter Readings — 18 participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
20-30% Salicylic Acid peels to the right side of the face (Drug); 20-30% Salicylic Acid peels to the left side of the face (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
University of Texas Southwestern Medical Center
Primary completion
Mar 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Showing Improvement of Melasma Based on Mexameter Readings		 18 —

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00616239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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