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Clinical Trial of Hydroquinone Versus Miconazol in Melasma

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ClinicalTrials.gov Identifier: NCT01661556
Recruitment Status : Unknown
Verified December 2014 by Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí.
Recruitment status was:  Recruiting
First Posted : August 9, 2012
Last Update Posted : December 2, 2014
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Melasma Drug: Miconazole Drug: Hydroquinone Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind Randomized Study of 2% Miconazol Versus 4% Hydroquinone in the Treatment for Melasma.
Study Start Date : October 2011
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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%).

  2. 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).

  3. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661556

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

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"
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

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
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí:
Melasma, miconazole, hydroquinone

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Protective Agents
Radiation-Protective Agents