A Single-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety, Tolerability and Pharmacokinetics of Various Concentrations of Topical SM04554 Solution in Male Subjects with Androgenetic Alopecia.
- Conditions
- Androgenetic AlopeciaSkin - Dermatological conditions
- Registration Number
- ACTRN12613000974707
- Lead Sponsor
- Samumed LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 30
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>To characterize the safety and tolerability of topical SM04554 solution (0.05%, 0.15% and 0.45%) applied to the scalp of male subjects with Androgenetic Alopecia. This is assessed by the following:<br>1. Collection of adverse events following the first administration of the study drug and up until Day 28 (14 days post the final administration of the study drug);<br>2. Non fasting clinical laboratory analysis of Chemistry, Haematology and urinalysis during the screening visit and on the 14th day of treatment and 14 days following the end of the treatment;<br>3. Collection of Vital Signs each day of treatment;<br>4. Daily assessment of the participants’ scalp each day prior to treatment.<br>5. ECG at screening, Day 1 and Day 14, prior to treatment and 4 hours after treatment.<br>[Day 1 to Day 14.]
- Secondary Outcome Measures
Name Time Method To characterize the pharmacokinetics (PK) of topical SM04554 solution (0.05%, 0.15%, 0.45%) applied to the scalp of male subjects with AGA<br>[PK samples will be taken on Day 1 and 2 and on Day 14 and 15 at the following timepoints:<br>Pre dose; and at 1,2,4,6,9,12 and 24 hours post dose.<br>];To assess hair growth and quality based upon questionnaires completed by the physician and subject.<br>[Hair growth will be assessed by the PI using an 'Investigator assessment scale' at Day 15 and Day 28.<br>Hair growth will be assessed by the subject using a 'subject assessment of hair growth' questionnaire at Day 15 and Day 28. Scalp photography will be taken prior to study drug administration and then again at Day 15 and 28.]