A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia

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 Status

Drug

Estimated Enrollment

625

Start Date

November 1, 2018

Completion Date

January 2021

Primary Completion Date

January 2021

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

NCT ID

NCT03742518

Organization ID

SM04554-AGA-05

Responsible Party

Sponsor

Study Sponsor

Samumed LLC

Study Sponsor

Yusuf Yazici, M.D., Study Director, Samumed LLC

Verification Date

December 2019