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

• ClinicalTrials.gov Identifier: NCT03742518
• Recruitment Status: Completed
• First Posted: November 15, 2018
• Last Update Posted: December 28, 2021
• Sponsor: Biosplice Therapeutics, Inc.
• Information provided by (Responsible Party): Biosplice Therapeutics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Androgenetic Alopecia	Drug: Topical SM04554 solution; Drug: Topical vehicle solution	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 675 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: November 1, 2018
• Actual Primary Completion Date: December 31, 2020
• Actual Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Topical SM04554 0.15% solution; Topical SM04554 0.15% solution, once daily for up to 48 weeks	Drug: Topical SM04554 solution; Study medication application will be performed by the individual subject at approximately the same time each day.
Experimental: Topical SM04554 0.25% solution; Topical SM04554 0.25% solution, once daily for up to 48 weeks	Drug: Topical SM04554 solution; Study medication application will be performed by the individual subject at approximately the same time each day.
Placebo Comparator: Vehicle; Topical vehicle solution, once daily for up to 48 weeks	Drug: Topical vehicle solution; Vehicle solution application will be performed by the individual subject at approximately the same time each day.

Outcome Measures

Primary Outcome Measures :

1. Absolute non-vellus hair count in target area [ Time Frame: Week 48 ]
   Absolute non-vellus hair count in target area by phototrichogram (PTG) analysis

Secondary Outcome Measures :

1. Absolute non-vellus hair count in target area [ Time Frame: Weeks 12, 24, and 36 ]
   Absolute non-vellus hair count in target area by PTG analysis
2. Absolute vellus hair count in target area [ Time Frame: Weeks 12, 24, 36 and 48 ]
   Absolute vellus hair count in target area by PTG analysis
3. Absolute total hair count in target area [ Time Frame: Weeks 12, 24, 36 and 48 ]
   Absolute total hair count in target area by PTG analysis
4. Change from baseline in non-vellus hair count in target area [ Time Frame: Baseline, and Weeks 12, 24, 36 and 48 ]
   Change from baseline in non-vellus hair count in target area by PTG analysis
5. Change from baseline in vellus hair count in target area [ Time Frame: Baseline, and Weeks 12, 24, 36 and 48 ]
   Change from baseline in vellus hair count in target area by PTG analysis
6. Change from baseline in total hair count in target area [ Time Frame: Baseline, and Weeks 12, 24, 36 and 48 ]
   Change from baseline in total hair count in target area by PTG analysis
7. Change from baseline in average non-vellus hair shaft thickness in target area [ Time Frame: Baseline, and Weeks 12, 24, 36 and 48 ]
   Change from baseline in average non-vellus hair shaft thickness in target area by PTG analysis
8. Change from baseline in average non-vellus hair density in target area [ Time Frame: Baseline, and Weeks 12, 24, 36 and 48 ]
   Change from baseline in average non-vellus hair density (cumulative non-vellus hair shaft thickness) in target area by PTG analysis
9. Subject assessment of hair growth [ Time Frame: Weeks 6, 12, 18, 24, 30, 36, 42 and 48 ]
   Subjects will complete a questionnaire for hair growth while referencing the global scalp photograph taken at the visit as compared to their baseline global scalp photograph. The scale for the questionnaire ranges from -3 to +3 (-3 indicates the worst outcome and +3 indicates the best outcome).
10. Change from baseline in subject assessment of hair satisfaction [ Time Frame: Baseline, and Weeks 6, 12, 18, 24, 30, 36, 42 and 48 ]
    Subjects will complete a questionnaire for hair satisfaction while referencing the global scalp photograph taken at the visit as compared to their baseline global scalp photograph. The scale for the questionnaire ranges from -3 to +3 (-3 indicates the worst outcome and +3 indicates the best outcome).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Turkey

Research Site

Ankara, Turkey, 06100

Research Site

Ankara, Turkey, 06110

Research Site

Ankara, Turkey, 06680

Research Site

Bursa, Turkey, 16059

Research Site

Denizli, Turkey, 20070

Research Site

Istanbul, Turkey, 34098

Research Site

Istanbul, Turkey, 34668

Research Site

İzmir, Turkey, 35180

Research Site

Kayseri, Turkey, 38039

Research Site

Kocaeli, Turkey, 41380

Research Site

Mersin, Turkey, 33343

Research Site

Samsun, Turkey, 55139

Research Site 1

Trabzon, Turkey, 61080

Research Site 2

Trabzon, Turkey, 61080

Sponsors and Collaborators

Biosplice Therapeutics, Inc.

Investigators

• Study Director: Yusuf Yazici, M.D.; Biosplice Therapeutics, Inc.

More Information

• Responsible Party: Biosplice Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03742518
• Other Study ID Numbers: SM04554-AGA-05
• First Posted: November 15, 2018
• Last Update Posted: December 28, 2021
• Last Verified: December 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biosplice Therapeutics, Inc.:

male pattern baldness; SM04554; AGA

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical; Pharmaceutical Solutions