A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing

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Brief Title

A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing

Official Title

A Phase 2, Multicenter, Randomized, Double-Blind Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia (AGA) Analyzed by Biopsy of the Scalp Prior To and Post Dosing

Brief Summary

      This study will assess the safety, tolerability, and efficacy of SM04554 at concentrations of
      0.15% and 0.25%. Improved knowledge of the changes in hair counts and immunohistochemical
      analysis associated with androgenetic alopecia (AGA) before and after treatment with SM04554
      and compared to placebo may lead to a greater understanding of the underlying mechanisms of
      action of SM04554.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in number of terminal hair follicles

Secondary Outcome

 Change in number of terminal hair follicles

Condition

Androgenetic Alopecia

Intervention

Topical SM04554 solution

Study Arms / Comparison Groups

 Experimental Arm 1
Description:  Topical SM04554 0.15% solution, once daily for approximately 90 days

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

49

Start Date

August 2015

Completion Date

April 2016

Primary Completion Date

April 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Clinical diagnosis of AGA with Norwood-Hamilton Classification score of 4, 5, 5A, 5V,
             or 6

          -  In good general health, as determined by the Investigator

          -  Willing and able to attend all study visits

          -  Willing to undergo two punch biopsies of the scalp

          -  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 not use permanent or semi-permanent hair products (e.g., color,
             texturizers, relaxers) for the duration of the study; daily styling products will be
             allowed on non-study visit days (e.g., hair gel, mousse, styling spray)

          -  Willing to use sponsor-supplied shampoo and conditioner in place of regular shampoo
             and conditioner, for the duration of the study; use of sponsor-supplied conditioner is
             optional for subjects who do not use conditioner

        Exclusion Criteria:

          -  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 a highly
             effective method of birth control and are not willing to use a highly 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, eczema, sun damage,
             seborrheic dermatitis, actinic keratosis), cuts and/or abrasions on the scalp or hands
             or condition (e.g., sunburn, tattoos) on the treatment area or hands that, in the
             opinion of the Investigator, might put the subject at risk or interfere with the study
             conduct or evaluations

          -  History of or current skin cancer (e.g., melanoma, basal cell carcinoma, squamous cell
             carcinoma) located anywhere on the body

          -  History of surgical correction of hair loss on the scalp

          -  Previous exposure to SM04554

          -  Use of blood thinners (e.g., Coumadin, Plavix, Lovenox, and aspirin >81mg); low dose
             aspirin (e.g., ≤81 mg) is allowable

          -  Use of any products or devices clinically proven to promote scalp hair growth (e.g.,
             finasteride or minoxidil) within 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

          -  Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30
             days prior to study start

          -  Use of medicated shampoo or conditioner (medicated shampoo and conditioner refer 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 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

          -  Poor peripheral venous access

          -  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

          -  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 any of its affiliates or development partners
             (that is, an employee, temporary contract worker, or designee) responsible for the
             conduct of the study
      

Gender

Male

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Yusuf Yazici, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02503137

Organization ID

SM04554-AGA-04


Responsible Party

Sponsor

Study Sponsor

Samumed LLC


Study Sponsor

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


Verification Date

February 2020