Clinical Trial of Hydroquinone Versus Miconazol in Melasma

Universidad Autonoma de San Luis Potosí

Status and phase: Unknown; Phase 4

Conditions: Melasma

Treatments: Drug: Hydroquinone; Drug: Miconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01661556

MICHQ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Miconazole

Experimental group

Description:

OTC topical prescription used for fungal treatment that can be useful to the treatment of melasma due to its depigmenting properties.

Treatment:

Drug: Miconazole

Hydroquinone

Active Comparator group

Description:

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.

Treatment:

Drug: Hydroquinone

Placebo

Placebo Comparator group

Description:

Moisturizer cream without pharmacological effects will be used as a control.