Clinical Trial of Hydroquinone Versus Miconazol in Melasma
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| ClinicalTrials.gov Identifier: NCT01661556 |
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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
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Melasma | Drug: Miconazole Drug: Hydroquinone | Phase 4 |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Miconazole
OTC topical prescription used for fungal treatment that can be useful to the treatment of melasma due to its depigmenting properties.
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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:
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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.
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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:
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Placebo Comparator: Placebo
Moisturizer cream without pharmacological effects will be used as a control.
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- 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.
- 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%).
- 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).
- 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.
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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
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 |
| 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 | |
| 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:
| 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:
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Melasma, miconazole, hydroquinone |
Additional relevant MeSH terms:
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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 |