None listed
Conditions
Brief summary
The main purpose of this study is to assess how safe and how well a topical solution, which is applied to the scalp of male participants who have a condition called male pattern baldness is tolerated. The secondary purpose is to assess how effective the topical solution is and also to assess the way the body absorbs, distributes and gets rid of the drug SM04554. .
Interventions
The study drug is a topical SM04554 solution. SM04554 is a small molecule that may activate the wnt pathway. The dosage amounts are: 0.05%; 0.15%; and 0.45%. Administration of the study drug will be once daily for 14 days at the study clinic; study drug is applied topically to the scalp. There are three cohorts of 10 participants. Cohort 1 will be administered the 0.05% solution, Cohort 2 will be administered the 0.15% solution and Cohort 3 will be administered the 0.45% solution. Participants w
The study drug is a topical SM04554 solution. SM04554 is a small molecule that may activate the wnt pathway. The dosage amounts are: 0.05%; 0.15%; and 0.45%. Administration of the study drug will be once daily for 14 days at the study clinic; study drug is applied topically to the scalp. There are three cohorts of 10 participants. Cohort 1 will be administered the 0.05% solution, Cohort 2 will be administered the 0.15% solution and Cohort 3 will be administered the 0.45% solution. Participants will complete a series of tests prior to the start of the study. During the study the participants’ scalp will be assessed by the study doctor on a daily basis and prior to administration of the study drug. Hair growth assessments will also be completed by the study doctor and the participant 1 day following the completion of the treatment and 14 days following completion of the treatment.
Sponsors
Samumed LLC
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Males between 18 and 60 years of age, inclusive Diagnosed with androgenetic (AGA) alopecia with a Norwood-Hamilton Classification score of 4, 5, 6 or 7. In good general health Willing and able to attend study visits Willing to maintain same hair style for the duration of the study Willing to use a sponsor supplied shampoo and conditioner for the duration of the study Able to comprehend and willing to sign an informed consent form
Exclusion criteria
Clinical diagnosis of alopecia areata or other non-AGA form 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 that is capable of becoming pregnant, neither of which have had surgery to become sterilized, who are not using an effective method of birth control (e.g., surgically implanted hormonal therapy, intrauterine devices or oral birth control with barrier method). 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. Use of finasteride or dutasteride within the 12 weeks prior to the Screening Visit. Use of minoxidil within the 12 weeks prior to the Screening Visit. Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyperoterone acetate, cimetidine) within 12 weeks prior to the Screening Visit. Use of any scalp hair growth products within the 12 weeks prior to the Screening Visit. History of hair transplants. Current use of an occlusive wig, hair extensions or hair weaves History of hypersensitivity or allergies to any ingredient of the study medications. Participation in any other investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to the Screening Visit. Poor peripheral venous access. Subjects with a history of clinically significant cardiac arrhythmia as determined by the principal investigator. Subjects with clinically significant findings from medical history, clinical laboratory tests, ECG and vital signs that, in the opinion of the investigator, could interfere with the objectives of the study or put the subject at risk.
Outcome results
None listed