Brief Title
A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia
Official Title
Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 0.15% & 0.25% Concentrations of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia
Brief Summary
This multi-center, randomized, double-blind, placebo-controlled study, conducted in Turkey,
will assess the efficacy and safety of topical SM04554 solution (0.15% and 0.25%) applied
daily to the scalp of male androgenetic alopecia (AGA) subjects.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Absolute non-vellus hair count in target area
Secondary Outcome
Absolute non-vellus hair count in target area
Condition
Androgenetic Alopecia
Intervention
Topical SM04554 solution
Study Arms / Comparison Groups
Topical SM04554 0.15% solution
Description: Topical SM04554 0.15% solution, once daily for up to 48 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
675
Start Date
November 1, 2018
Completion Date
December 31, 2020
Primary Completion Date
December 31, 2020
Eligibility Criteria
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 topical
investigational product and direct contact should be avoided as potential harm to a
fetus 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 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 (e.g., hair gel, mousse, styling
spray) will be allowed on non-study visit days
- Willing to use mild non-medicated shampoo and conditioner for the duration of the
study
- 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 use
condom or whose partner is not using a highly effective method of birth control that
includes double barrier, intrauterine device, or hormonal contraceptive combined with
single barrier, or abstinence during the study treatment period until 90 days post
last 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 hair
loss on the scalp
- Previous exposure to SM04554
- Use of any products (e.g., finasteride, minoxidil, platelet rich plasma, biotin) or
devices (e.g., laser light therapy) purported to promote scalp hair growth within 24
weeks prior to the start of the study
- Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone
acetate, 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, which
includes or 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 the start of the study
- Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30
days prior to the start of the study
- Use of medicated shampoo or conditioner (medicated shampoo and conditioner refers 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 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 the
investigative site, or are directly affiliated with the study at the investigative
site
- Subjects employed by Samumed, LLC or Samumed Turkey, or any of its affiliates or
development partners (i.e., an employee, temporary contract worker, or designee)
responsible for the conduct of the study
Gender
Male
Ages
18 Years - 45 Years
Accepts Healthy Volunteers
No
Contacts
Yusuf Yazici, M.D., ,
Location Countries
Turkey
Location Countries
Turkey
Administrative Informations
NCT ID
NCT03742518
Organization ID
SM04554-AGA-05
Responsible Party
Sponsor
Study Sponsor
Biosplice Therapeutics, Inc.
Study Sponsor
Yusuf Yazici, M.D., Study Director, Biosplice Therapeutics, Inc.
Verification Date
January 2021