Clinical Trial of Hydroquinone Versus Miconazol in Melasma

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

Double Blind Randomized Study of 2% Miconazol Versus 4% Hydroquinone in the Treatment for 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 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.

Study Overview

Status

Unknown

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 depigmenting compounds such as hydroquinone, are still the gold standard in this condition. Miconazol has depigmented properties that could be used as part of the treatment in melasma patients. This effect is exerted by inhibiting the tyrosinase enzyme. So, the primary objective of this study is to compare the depigmenting activity of miconazole against hydroquinone.

Patients who are included in the study will be randomly assigned to receive one of the treatments, which should use for 12 weeks. The medications should be applied in the affected regions twice a day.

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 (Anticipated)

60

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 Contact

  • Name: Amalia Reyes-Herrera, M.D.
  • Phone Number: 52014448342795

Study Contact Backup

  • Name: Juan P Castanedo-Cazares, M.D.
  • Phone Number: 52014448342795
  • Email: castanju@yahoo.com

Study Locations

  • Mexico
      • San Luis Potosí, Mexico, 78210
        • Recruiting
        • Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
        • Contact:
          • Juan Pablo Castanedo-Cazares, M.D.
          • Phone Number: 52014448342795
          • Email: castanju@yahoo.com
        • Contact:

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

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Signed informed consent
  • Mexican women over 18 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 sunblock
  • 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Miconazole
OTC topical prescription used for fungal treatment that can be useful to the treatment of melasma due to its depigmenting properties.
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.
Other Names:
  • Canesten
  • Monistat
  • Micatin
Active Comparator: Hydroquinone
Hydroquinone 4% cream (Topical use) a depigmenting agent used as reference will be used as control. It will be applied twice a day for 9 weeks.
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.
Other Names:
  • Eldoquin
  • Melanex
Placebo Comparator: Placebo
Moisturizer cream without pharmacological effects will be used as a control.

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 is pure white, 100 y total dark.
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
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 Fontana Masson stain
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 Director: Juan P Castanedo-Cazares, M.D., Hospital Central "Dr. Ignacio Morones Prieto". UASLP
  • Principal Investigator: Amalia Reyes-Herrera, M.D., Hospital Central "Dr. Ignacio Morones Prieto". UASLP
  • Study Chair: Bertha Torres-Alvarez, M.D., Hospital Central "Dr. Ignacio Morones Prieto". UASLP

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

October 1, 2011

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 7, 2012

First Submitted That Met QC Criteria

August 7, 2012

First Posted (Estimate)

August 9, 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

  • MICHQ

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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