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
Biosplice Therapeutics, Inc.
Study Sponsor
Yusuf Yazici, M.D., Study Director, Biosplice Therapeutics, Inc.
Verification Date
February 2020