Clinical Trial of Hydroquinone Versus Miconazol in Melasma

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Universidad Autonoma de San Luis Potosí
Sponsor:
Collaborator:
Hospital Central "Dr. Ignacio Morones Prieto"
Information provided by (Responsible Party):
Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:
NCT01661556
First received: August 7, 2012
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Melasma
Drug: Miconazole
Drug: Hydroquinone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind Randomized Study of 2% Miconazol Versus 4% Hydroquinone in the Treatment for Melasma.

Resource links provided by NLM:


Further study details as provided by Universidad Autonoma de San Luis Potosí:

Primary Outcome Measures:
  • Depigmentation of melasma lesions by Colorimetry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Global Physician Assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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%).

  • MASI (Melasma Area Severity Index) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Melanin content by Fontana Masson stain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661556

Contacts
Contact: Amalia Reyes-Herrera, M.D. 52014448342795
Contact: Juan P Castanedo-Cazares, M.D. 52014448342795 castanju@yahoo.com

Locations
Mexico
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto" Recruiting
San Luis Potosí, Mexico, 78210
Contact: Juan Pablo Castanedo-Cazares, M.D.    52014448342795    castanju@yahoo.com   
Contact: Bertha Torres-Alvarez, M.D.    52014448342795    torresmab@yahoo.com.mx   
Sponsors and Collaborators
Universidad Autonoma de San Luis Potosí
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
  More Information

Publications:
Responsible Party: Juan Pablo Castanedo-Cazares, Clinical Professor. Dermatology department., Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier: NCT01661556     History of Changes
Other Study ID Numbers: MICHQ
Study First Received: August 7, 2012
Last Updated: December 9, 2013
Health Authority: Mexico: Ministry of Health

Keywords provided by Universidad Autonoma de San Luis Potosí:
Melasma, miconazole, hydroquinone

Additional relevant MeSH terms:
Hyperpigmentation
Melanosis
Pigmentation Disorders
Skin Diseases
Miconazole
Clotrimazole
Hydroquinone
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Antioxidants
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents

ClinicalTrials.gov processed this record on August 19, 2014