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

December 1, 2014 updated by: Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí

A Double Blind Randomized Study Comparing the Ultraviolet (UV) Photoprotection With UV Plus Visible Light Photoprotection in the Treatment of Melasma.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Melasma is a common acquired hypermelanosis in dark skin populations, usually characterized by symmetrical, irregular macules occurring in photo-exposed areas such as face. Treatment with sunscreens and depigmenting compounds such as hydroquinone, are still the gold standard in this condition.

Visible light has pigmenting properties that could be interfering with the treatment in melasma patients. So, the primary objective of this study is to compare the depigmenting adjuvant effect of using a UV-visible blocking sunscreen against a UV sunscreen.

Patients who are included in the study will be randomly assigned to receive one of the sunscreen type, which should use for 12 weeks. The sun blocking agents should be applied in the affected regions every 3 hours from 8AM to 5PM. The evaluation of clinical improvement will be done in a blinded modality by means of the MASI score, the Global Physician Assessment, as well as colorimetry and histological melanin content. Evaluations will be held on visits at 4, 8 and 12 weeks. Skin biopsy will be taken at onset and at 12 weeks.

At the end of the study, data will be compared concerning the former parameters. All side effects will be recorded and analysed.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • San Luis Potosi, Mexico, 78210
        • Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Signed informed consent
  • Women over 25 years of age
  • Dermatologic diagnostic of melasma
  • Phototype III or more

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Postbirth, abortion in the past 6 months
  • Having an endocrine or autoimmune disease
  • Under hormonal therapy of any kind including contraceptives or it´s use in the past 6 months
  • Currently under treatment for melasma including sunscreens
  • Currently under radiation therapy, chemotherapy, immunosuppressants of any kind or phototherapy or it´s use in the past 6 months
  • Having used or are consuming photosensitizing substances, oral or topical

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 290-400 nm sunscreen

Sunscreen containing Mexoryl SX, Mexoryl XL, Titanium Dioxide, Octocrylene, Tinosorb S, Avobenzone, and Ethylhexyl triazone.

Fluid vehicle administered daily, from 8AM to 5PM every 3 hr, for 12 weeks.
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.
Other Names:
  • Octocrylene
  • Titanium dioxide
  • Butyl methoxydibenzoylmethane
  • Bis-ethylhexyloxyphenol methoxyphenyl triazine
  • Drometrizole trisiloxane
  • Ethylhexyl triazone
  • Terephthalylidene dicamphor sulfonic acid
Experimental: 290-800 nm sunscreen

Sunscreen containing Benzophenone-3, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide, and iron oxide.

Fluid vehicle administered daily, from 8AM to 5PM every 3 hr, for 12 weeks.
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.
Other Names:
  • Octocrylene
  • Benzophenone-3
  • Octinoxate
  • Titanium Dioxide
  • Zinc Oxide
  • Iron oxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depigmentation of melasma lesions by Colorimetry
Time Frame: 12 weeks
Quantification of the colour change in the melasma lesions by means of the L axis of the CIE system. 0 value is pure white, 100 value is total black.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Physician Assessment
Time Frame: 12 weeks
Clinical improvement is assessed by means of digital photographic registration (frontal, right, and left views). An independent observer clinically graded the global improvement as poor (0-25%), mild (26-50%), good (51-75%), and excellent (>75%).
12 weeks
MASI (Melasma Area Severity Index)
Time Frame: 12 weeks
It is a clinical instrument of melasma measurement. The total score would range from 0-24, involving the forehead (30%), right malar (30%), left malar (30%) and chin (10%), and using area of involvement (0=absent, 1=<10%, 2=10%-29%, 3=30%-49%, 4=50%-69%, 5=70%-89% and 6=90%-100%) and darkness (0=absent, 1=slight, 2=mild, 3=marked and 4=severe). Computation would be as follows: 0.3 A(f) D(f) + 0.3 A(lm) D(lm) + 0.3 A(rm) D(rm) + 0.1 A(c) D(c).
12 weeks
Melanin content by histologic quantification.
Time Frame: 12 weeks
The Fontana-Masson Stain is specific for melanin, this histochemical reaction reveals accumulations of black material wherever melanin is located. A skin biopsy of lesions will be taken initially and at the end of study. The melanin content will be quantified by a software image analysis of the slides.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de San Luis Potosí

Collaborators

Hospital Central "Dr. Ignacio Morones Prieto"

Investigators

  • Study Chair: Bertha Torres-Alvarez, MD, Hospital Central "Dr. Ignacio Morones Prieto"
  • Principal Investigator: Diana Hernandez-Blanco, MD, Hospital Central "Dr. Ignacio Morones Prieto"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

September 25, 2012

First Submitted That Met QC Criteria

September 27, 2012

First Posted (Estimate)

September 28, 2012

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VISUV-melasma

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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