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

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ClinicalTrials.gov Identifier: NCT03742518
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 625 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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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.




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).



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742518


Contacts
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Contact: Samumed Clinical Trials 1-855-222-0515 clinicaltrials@samumed.com

Locations
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Turkey
Research Site Recruiting
Ankara, Turkey, 06100
Research Site Recruiting
Ankara, Turkey, 06110
Research Site Recruiting
Ankara, Turkey
Research Site Recruiting
Bursa, Turkey, 16059
Research Site Recruiting
Istanbul, Turkey, 34098
Research Site 2 Recruiting
Istanbul, Turkey, 34668
Research Site Recruiting
Kayseri, Turkey, 38039
Research Site Recruiting
Mersin, Turkey, 33343
Research Site Recruiting
Samsun, Turkey, 55139
Research Site Recruiting
Trabzon, Turkey, 61080
Sponsors and Collaborators
Samumed LLC
Investigators
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Study Director: Yusuf Yazici, M.D. Samumed LLC

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Responsible Party: Samumed LLC
ClinicalTrials.gov Identifier: NCT03742518     History of Changes
Other Study ID Numbers: SM04554-AGA-05
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019

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

Keywords provided by Samumed LLC:
male pattern baldness
SM04554
AGA

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Pharmaceutical Solutions