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A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)

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: NCT02275351
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

Tracking Information
First Submitted Date  ICMJE October 23, 2014
First Posted Date  ICMJE October 27, 2014
Last Update Posted Date July 26, 2018
Actual Study Start Date  ICMJE November 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2014)
  • Change in non-vellus hair count [ Time Frame: Baseline, Day 45, Day 90 ]
    Change in non-vellus hair count over time as compared to Baseline. Non-vellus hair count will be determined by macrophotography.
  • Change in subject assessment of hair growth and quality [ Time Frame: Day 45, Day 90 ]
    Change in Men's Hair Growth Questionnaire (MHGQ) over time as compared to Baseline. The MHGQ is a subject-completed assessment that asks the subject to evaluate his hair growth and quality since the start of the study.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02275351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2014)
  • Change in hair growth as assessed by the investigator [ Time Frame: Day 45, Day 90 ]
    Change in hair growth over time as compared to Baseline, as assessed by the investigator, using a 7-point scale from -3 (greatly decreased) to +3 (greatly increased).
  • Impact of AGA on quality of life [ Time Frame: Baseline, Day 45, Day 90 ]
    Change in subject responses to the Kingsley Alopecia Profile (KAP) questionnaire over time as compared to Baseline. The KAP is a 38-question survey completed by each subject that assesses his quality of life in relation to AGA.
  • Change in hair density [ Time Frame: Baseline, Day 45, Day 90 ]
    Change in hair density over time as compared to Baseline. Hair density will be measured using macrophotography.
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 of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)
Official Title  ICMJE A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle- Controlled Study of the Safety, Tolerability, and Efficacy of 0.15% and 0.25% Concentrations of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)
Brief Summary The purpose of this study is to characterize the safety, tolerability, and efficacy of topical SM04554 solution (0.15% and 0.25%) applied to the scalp of male subjects with Androgenetic Alopecia (AGA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE
  • Drug: SM04554
    Topical solution, applied once a day
  • Drug: Vehicle
    Topical solution, applied once a day
Study Arms  ICMJE
  • Experimental: Active Arm 1
    Topical SM04554 0.15% solution, applied once a day for 90 days
    Intervention: Drug: SM04554
  • Experimental: Active Arm 2
    Topical SM04554 0.25% solution, applied once a day for 90 days
    Intervention: Drug: SM04554
  • Placebo Comparator: Vehicle Arm
    Topical vehicle solution, applied once a day for 90 days
    Intervention: Drug: Vehicle
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 Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2015)
310
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2014)
300
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of AGA
  • 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 maintain the same hair style as at 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 will be allowed (e.g., hair gel, mousse, styling spray).
  • Willing to use a mild non-medicated shampoo and conditioner for the duration of the study
  • Willing to receive a small scalp tattoo
  • Able to read and understand English

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 an effective method of birth control and are not willing to use an 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, skin cancer, eczema, sun damage, seborrheic dermatitis), cuts and/or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations
  • History of surgical correction of hair loss on the scalp
  • Previous exposure to SM04554
  • Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 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
  • 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
  • Subjects with a history of clinically significant cardiac arrhythmia as determined by the Investigator
  • Subjects with clinically significant findings from medical history, clinical laboratory tests, electrocardiogram (ECG), or vital signs that, in the opinion of the Investigator, could interfere with the objectives of the study or put the subject at risk
  • 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
  • Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30 days prior to study start
  • Use of medicated shampoo or conditioner within 30 days prior to study start
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02275351
Other Study ID Numbers  ICMJE SM04554-AGA-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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 July 2018

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