A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)

Brief Title

A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)

Official Title

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle- Controlled Study of the Safety, Tolerability, and Efficacy of 0.15% and 0.25% Concentrations of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)

Brief Summary

      The purpose of this study is to characterize the safety, tolerability, and efficacy of
      topical SM04554 solution (0.15% and 0.25%) applied to the scalp of male subjects with
      Androgenetic Alopecia (AGA).
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Change in non-vellus hair count

Secondary Outcome

 Change in hair growth as assessed by the investigator

Condition

Androgenetic Alopecia

Intervention

SM04554

Study Arms / Comparison Groups

 Active Arm 1

Description:  Topical SM04554 0.15% solution, applied once a day for 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 Status

Drug

Estimated Enrollment

310

Start Date

November 2014

Completion Date

November 2015

Primary Completion Date

November 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Clinical diagnosis of AGA

          -  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 maintain the same hair style as at 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 will be allowed (e.g., hair gel,
             mousse, styling spray).

          -  Willing to use a mild non-medicated shampoo and conditioner for the duration of the
             study

          -  Willing to receive a small scalp tattoo

          -  Able to read and understand English

        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 an effective
             method of birth control and are not willing to use an 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, 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

          -  Previous exposure to SM04554

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

          -  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

          -  Subjects with a history of clinically significant cardiac arrhythmia as determined by
             the Investigator

          -  Subjects with clinically significant findings from medical history, clinical
             laboratory tests, electrocardiogram (ECG), or vital signs that, in the opinion of the
             Investigator, could interfere with the objectives of the study or put the subject at
             risk

          -  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

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

          -  Use of medicated shampoo or conditioner within 30 days prior to study start
      

Gender

Male

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Yusuf Yazici, M.D., , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT02275351

Organization ID

SM04554-AGA-02

Responsible Party

Sponsor

Study Sponsor

Biosplice Therapeutics, Inc.

Study Sponsor

Yusuf Yazici, M.D., Study Director, Biosplice Therapeutics, Inc.

Verification Date

February 2020