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Study aim
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Examining efficacy and safety of lipid nanostructures loaded with dutasteride and pumpkin seed oil on volunteers with androgenic alopecia
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Design
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Two arm parallel group, not randomized, not blinded, trial with phase 2-3 on 24 healthy valunteers
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Settings and conduct
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Applied Pharmaceutical Research Center of Tabriz Medical Sciences. 24 healthy male volunteers, aged 20 to 70, who have mild to moderate androgenic alopecia. The front of the volunteer's head is divided into two parts, in one area of oil formulation and in one area of nano formulation, it is used once every three days for 6 months. Volunteers will be selected from among friends, acquaintances and relatives
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: male volunteers diagnosed with mild to moderate androgenic alopecia. Be between 20-70 years old. People who agreed to the informed consent form. Exclusion criteria: receiving any prescription of finasteride and its anti-androgen properties 8 weeks before starting Dutasteride, history of malignancy other than
non-melanotic cancers, any diagnosis of global hair thinning or any other scalp or hair disease, history of infertility and varicocele, simultaneous use of Over-the-counter corticosteroids, anabolic steroids, or "hair restorers." Light or laser treatment of the scalp in the last 3 months, previous correction of hair loss surgery, scars, sensitivity and local infections in the scalp
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Intervention groups
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Volunteers use topical oily and nano formulations for 6 months; At the beginning, in the third month and in the sixth month, they fill out a questionnaire, an imaging of the head area is done, and they are examined by a doctor
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Main outcome variables
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New hair growth; Area hair density; Hair thickness; Hair growth rate