A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia

Inclusion Criteria:

• Being a Turkish citizen
• Clinical diagnosis of AGA with Norwood-Hamilton Classification score of 3V or 4
• Willing to inform females, with whom they may interact, that they are using a topicalinvestigational product and direct contact should be avoided as potential harm to afetus is unknown
• Willing and able to attend all study visits
• Willing to maintain the same hair style and length as at the study start for theduration of the study
• Willing to not use semi-permanent hair products (e.g., color, texturizers, relaxers)for the duration of the study; daily styling products (e.g., hair gel, mousse, stylingspray) will be allowed on non-study visit days
• Willing to use mild non-medicated shampoo and conditioner for the duration of thestudy
• Able to read and understand Turkish
• Ability to comprehend and willing to sign an informed consent form

Exclusion Criteria:

• Males who are sexually active, and have a partner who is capable of becoming pregnant,if neither has had surgery to become sterilized, and/or who are not willing to usecondom or whose partner is not using a highly effective method of birth control thatincludes double barrier, intrauterine device, or hormonal contraceptive combined withsingle barrier, or abstinence during the study treatment period until 90 days postlast dose of study medication
• Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
• Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
• History of surgical correction (e.g., hair transplantation, scalp reduction) of hairloss on the scalp
• Previous exposure to SM04554
• Use of any products (e.g., finasteride, minoxidil, platelet rich plasma, biotin) ordevices (e.g., laser light therapy) purported to promote scalp hair growth within 24weeks prior to the start of the study
• Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproteroneacetate, cimetidine) within 12 weeks prior to the start of the study
• Use of medications that potentially cause drug-induced hair loss (e.g.,depotestosterone, haloperidol, methotrexate, methylprednisolone, prednisone,testosterone, divalproex sodium) within 12 weeks prior to the start of the study
• Current use of an occlusive wig, hair extensions, or hair weaves
• History of hypersensitivity or allergies to any ingredient of the study medication
• Participation in any other investigational drug or medical device trial, whichincludes or included administration of an investigational study medication or medicaldevice, within 30 days or 5 half-lives of the investigational agent, whichever islonger, prior to the start of the study
• Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30days prior to the start of the study
• Use of medicated shampoo or conditioner (medicated shampoo and conditioner refers toany prescription shampoo or conditioner as well as any over-the-counter medicatedshampoo or conditioner, such as those for treatment of dandruff or promoting hairgrowth) within 30 days prior to the start of the study
• Subjects who are immediate family members (spouse, parent, child, or sibling;biological or legally adopted) of personnel directly affiliated with the study at theinvestigative site, or are directly affiliated with the study at the investigativesite
• Subjects employed by Samumed, LLC or Samumed Turkey, or any of its affiliates ordevelopment partners (i.e., an employee, temporary contract worker, or designee)responsible for the conduct of the study