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
18–55
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Clinical diagnosis of AGA
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 maintain the same hair style as at study start for the duration 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 will be allowed (e.g., hair gel, mousse, styling spray).
Willing to use a mild non-medicated shampoo and conditioner for the duration of the study
Willing to receive a small scalp tattoo
Able to read and understand English
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 an effective method of birth control and are not willing to use an 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, skin cancer, eczema, sun damage, seborrheic dermatitis), cuts and/or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations
History of surgical correction of hair loss on the scalp
Previous exposure to SM04554
Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 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
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
Subjects with a history of clinically significant cardiac arrhythmia as determined by the Investigator
Subjects with clinically significant findings from medical history, clinical laboratory tests, electrocardiogram (ECG), or vital signs that, in the opinion of the Investigator, could interfere with the objectives of the study or put the subject at risk
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
Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30 days prior to study start
Use of medicated shampoo or conditioner within 30 days prior to study start
Clareo Health | A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)
