Clinical Trial of Hydroquinone Versus Miconazol in Melasma

Study Description

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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

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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

Arms and Interventions

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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

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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

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Navarrete-Solís J, Castanedo-Cázares JP, Torres-Álvarez B, Oros-Ovalle C, Fuentes-Ahumada C, González FJ, Martínez-Ramírez JD, Moncada B. A Double-Blind, Randomized Clinical Trial of Niacinamide 4% versus Hydroquinone 4% in the Treatment of Melasma. Dermatol Res Pract. 2011;2011:379173. doi: 10.1155/2011/379173. Epub 2011 Jul 21.

Torres-Álvarez B, Mesa-Garza IG, Castanedo-Cázares JP, Fuentes-Ahumada C, Oros-Ovalle C, Navarrete-Solis J, Moncada B. Histochemical and immunohistochemical study in melasma: evidence of damage in the basal membrane. Am J Dermatopathol. 2011 May;33(3):291-5. doi: 10.1097/DAD.0b013e3181ef2d45.

Moncada B, Sahagún-Sánchez LK, Torres-Alvarez B, Castanedo-Cázares JP, Martínez-Ramírez JD, González FJ. Molecular structure and concentration of melanin in the stratum corneum of patients with melasma. Photodermatol Photoimmunol Photomed. 2009 Jun;25(3):159-60. doi: 10.1111/j.1600-0781.2009.00425.x.

Hernández-Barrera R, Torres-Alvarez B, Castanedo-Cazares JP, Oros-Ovalle C, Moncada B. Solar elastosis and presence of mast cells as key features in the pathogenesis of melasma. Clin Exp Dermatol. 2008 May;33(3):305-8. doi: 10.1111/j.1365-2230.2008.02724.x.

Espinal-Perez LE, Moncada B, Castanedo-Cazares JP. A double-blind randomized trial of 5% ascorbic acid vs. 4% hydroquinone in melasma. Int J Dermatol. 2004 Aug;43(8):604-7.

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
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:

Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Miconazole; Hydroquinone; 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; Antioxidants; Protective Agents; Radiation-Protective Agents