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Clinical Trial of Hydroquinone Versus Miconazol in Melasma

NCT01661556 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-12-02

No results posted yet for this study

Summary

Melasma is an acquired discoloration of the skin characterized by brown colour changes commonly on the face.The duration of this double-blind clinical trial will be 12 weeks. The control group will receive treatment with topical Hydroquinone (4%), and the other group topical miconazole. Miconazol has antimelanotic properties and can be used as treatment for melasma patients. The estimated number of subjects to be recruited and randomized for the study is at least 30. The purpose of this study is determine if there is a difference in the effectiveness of these two agents. Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, and 12. Photographs, colorimetry and histological assessment will be also evaluated. Occurrence of adverse effects will also be recorded.

Conditions

  • Melasma

Interventions

DRUG

Miconazole

Miconazole 2% cream will be applied twice a day for 9 weeks. The affected surface will be washed and dried before application with a thin layer of the emulsion as indicated on the affected areas of the face.

DRUG

Hydroquinone

Hydroquinone 4% cream (Topical use), will be applied twice a day for 9 weeks. The affected surface will be washed and dried before application with a thin layer of the emulsion on affected areas of the face.

Sponsors & Collaborators

  • Hospital Central "Dr. Ignacio Morones Prieto"

    collaborator OTHER

  • Universidad Autonoma de San Luis Potosí

    lead OTHER

Principal Investigators

  • Juan P Castanedo-Cazares, M.D. · Hospital Central "Dr. Ignacio Morones Prieto". UASLP

  • Amalia Reyes-Herrera, M.D. · Hospital Central "Dr. Ignacio Morones Prieto". UASLP

  • Bertha Torres-Alvarez, M.D. · Hospital Central "Dr. Ignacio Morones Prieto". UASLP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-02-28
Completion
2015-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01661556 on ClinicalTrials.gov