Clinical Trial of Hydroquinone Versus Miconazol in Melasma

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Autonoma de San Luis Potosí
• Collaborator: Hospital Central "Dr. Ignacio Morones Prieto"
• Treatments: Hydroquinone; Miconazole

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