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Ultraviolet and UV-Visible Light Photoprotection for the Treatment of Melasma

NCT01695356 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

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 a Broad spectrum UV sunscreen. The experimental group, 4% topical hydroquinone and a Broad spectrum UV-visible light sunscreen. Visible light has melanotic properties and avoiding it can be part of the treatment for melasma patients. The estimated number of subjects to be recruited and randomized for the study is at least 25 per group. The purpose of this study is determine if there is a difference in the improvement between these two sunscreens types. 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

290-400 nm sunscreen

A broad UV spectrum sunscreen will be applied every 3 hours for 12 weeks. The affected surface will be covered with a 2 mg/cm\^2 layer of the product as indicated on the affected areas of the face.

DRUG

290-800 nm sunscreen

A UV-visible light spectrum sunscreen will be applied every 3 hours for 12 weeks. The affected surface will be covered with a 2 mg/cm\^2 layer of the product as indicated on the 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

  • Diana Hernandez-Blanco, MD · Hospital Central "Dr. Ignacio Morones Prieto"

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

  • Bertha Torres-Alvarez, MD · Hospital Central "Dr. Ignacio Morones Prieto"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-10-31
Completion
2013-11-30

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 NCT01695356 on ClinicalTrials.gov