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

NCT03742518 | Completed Phase 2 FDA Drug

• 1 other identifier: SM04554-AGA-05
• Study Type: interventional
• Target: 675
• Locations: 1 country
• Sites: 14

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.

Conditions

Androgenetic Alopecia

Keywords

male pattern baldness; SM04554; AGA

Outcome Measures

Primary Outcomes (1)

• Absolute non-vellus hair count in target area

  Absolute non-vellus hair count in target area by phototrichogram (PTG) analysis

  Week 48

Secondary Outcomes (10)

• Absolute non-vellus hair count in target area

  Weeks 12, 24, and 36

• Absolute vellus hair count in target area

  Weeks 12, 24, 36 and 48

• Absolute total hair count in target area

  Weeks 12, 24, 36 and 48

• Change from baseline in non-vellus hair count in target area

  Baseline, and Weeks 12, 24, 36 and 48

• Change from baseline in vellus hair count in target area

  Baseline, and Weeks 12, 24, 36 and 48

Study Arms (3)

Topical SM04554 0.15% solution

EXPERIMENTAL

Topical SM04554 0.15% solution, once daily for up to 48 weeks

Drug: Topical SM04554 solution

Topical SM04554 0.25% solution

EXPERIMENTAL

Topical SM04554 0.25% solution, once daily for up to 48 weeks

Drug: Topical SM04554 solution

Vehicle

PLACEBO COMPARATOR

Topical vehicle solution, once daily for up to 48 weeks

Drug: Topical vehicle solution

Interventions

Topical SM04554 solution DRUG

Study medication application will be performed by the individual subject at approximately the same time each day.

Topical SM04554 0.15% solution

Topical vehicle solution DRUG

Vehicle solution application will be performed by the individual subject at approximately the same time each day.

Vehicle

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosplice Therapeutics, Inc.: lead

Study Sites (14)

Research Site

Ankara, 06100, Turkey (Türkiye)

Location

Research Site

Ankara, 06110, Turkey (Türkiye)

Location

Research Site

Ankara, 06680, Turkey (Türkiye)

Location

Research Site

Bursa, 16059, Turkey (Türkiye)

Location

Research Site

Denizli, 20070, Turkey (Türkiye)

Location

Research Site

Istanbul, 34098, Turkey (Türkiye)

Location

Research Site

Istanbul, 34668, Turkey (Türkiye)

Location

Research Site

Izmir, 35180, Turkey (Türkiye)

Location

Research Site

Kayseri, 38039, Turkey (Türkiye)

Location

Research Site

Kocaeli, 41380, Turkey (Türkiye)

Location

Research Site

Mersin, 33343, Turkey (Türkiye)

Location

Research Site

Samsun, 55139, Turkey (Türkiye)

Location

Research Site 1

Trabzon, 61080, Turkey (Türkiye)

Location

Research Site 2

Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yusuf Yazici, M.D.

  Biosplice Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 15, 2018
• Study Start: November 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

TU (14)