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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742518
Recruitment Status : Active, not recruiting
First Posted : November 15, 2018
Last Update Posted : December 27, 2019
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

Tracking Information
First Submitted Date  ICMJE November 13, 2018
First Posted Date  ICMJE November 15, 2018
Last Update Posted Date December 27, 2019
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
Absolute non-vellus hair count in target area [ Time Frame: Week 48 ]
Absolute non-vellus hair count in target area by phototrichogram (PTG) analysis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE
  • Drug: Topical SM04554 solution
    Study medication application will be performed by the individual subject at approximately the same time each day.
  • Drug: Topical vehicle solution
    Vehicle solution application will be performed by the individual subject at approximately the same time each day.
Study Arms  ICMJE
  • Experimental: Topical SM04554 0.15% solution
    Topical SM04554 0.15% solution, once daily for up to 48 weeks
    Intervention: Drug: Topical SM04554 solution
  • Experimental: Topical SM04554 0.25% solution
    Topical SM04554 0.25% solution, once daily for up to 48 weeks
    Intervention: Drug: Topical SM04554 solution
  • Placebo Comparator: Vehicle
    Topical vehicle solution, once daily for up to 48 weeks
    Intervention: Drug: Topical vehicle solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2018)
625
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03742518
Other Study ID Numbers  ICMJE SM04554-AGA-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samumed LLC
Study Sponsor  ICMJE Samumed LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yusuf Yazici, M.D. Samumed LLC
PRS Account Samumed LLC
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP