Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biosplice Therapeutics, Inc.
Age
18–65
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Clinical diagnosis of AGA with Norwood-Hamilton Classification score of 4, 5, 5A, 5V, or 6
In good general health, as determined by the Investigator
Willing and able to attend all study visits
Willing to undergo two punch biopsies of the scalp
Willing to inform females, with whom they may interact, that they are using a topical investigational product and direct contact should be avoided as potential harm to a fetus is unknown
Willing to not use permanent or semi-permanent hair products (e.g., color, texturizers, relaxers) for the duration of the study; daily styling products will be allowed on non-study visit days (e.g., hair gel, mousse, styling spray)
Willing to use sponsor-supplied shampoo and conditioner in place of regular shampoo and conditioner, for the duration of the study; use of sponsor-supplied conditioner is optional for subjects who do not use conditioner
You may not be if
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
Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized, that are not using a highly effective method of birth control and are not willing to use a highly effective method of birth control during the study treatment period until 90 days post last dose of study medication
Current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, seborrheic dermatitis, actinic keratosis), cuts and/or abrasions on the scalp or hands or condition (e.g., sunburn, tattoos) on the treatment area or hands that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations
History of or current skin cancer (e.g., melanoma, basal cell carcinoma, squamous cell carcinoma) located anywhere on the body
History of surgical correction of hair loss on the scalp
Previous exposure to SM04554
Use of blood thinners (e.g., Coumadin, Plavix, Lovenox, and aspirin \>81mg); low dose aspirin (e.g., ≤81 mg) is allowable
Use of any products or devices clinically proven to promote scalp hair growth (e.g., finasteride or minoxidil) within 24 weeks prior to study start
Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine) within 12 weeks prior to study start
Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30 days prior to study start
Use of medicated shampoo or conditioner (medicated shampoo and conditioner refer to any prescription shampoo or conditioner as well as any over-the-counter medicated shampoo or conditioner, such as those for treatment of dandruff or promoting hair growth) within 30 days prior to study start
History of hair transplants
Current use of an occlusive wig, hair extensions, or hair weaves
Participation in any other investigational drug or medical device trial which included administration of an investigational study medication or medical device, within 30 days or 5 half-lives of the investigational agent, whichever is longer, prior to study start
Poor peripheral venous access
Subjects unwilling to refrain from sperm donation during the study treatment period until 90 days post last dose of study medication
Subjects with pregnant partners at study start
Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study
Clareo Health | A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing
