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A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing

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: NCT02503137
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

Tracking Information
First Submitted Date  ICMJE July 16, 2015
First Posted Date  ICMJE July 20, 2015
Last Update Posted Date February 17, 2020
Study Start Date  ICMJE August 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • Change in number of terminal hair follicles [ Time Frame: Baseline and Day 91 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of terminal hair follicles over the treatment period.
  • Change in number of anagen hair follicles [ Time Frame: Baseline and Day 91 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of anagen hair follicles over the treatment period.
  • Change in number of telogen hair follicles [ Time Frame: Baseline and Day 91 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of telogen hair follicles over the treatment period.
  • Change in number of catagen hair follicles [ Time Frame: Baseline and Day 91 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of catagen hair follicles over the treatment period.
  • Change in number of vellus (vellus-like) miniaturized hair follicles [ Time Frame: Baseline and Day 91 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of vellus (vellus-like) miniaturized hair follicles over the treatment period.
  • Change in number of indeterminate hair follicles [ Time Frame: Baseline and Day 91 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of indeterminate hair follicles over the treatment period.
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2015)
  • Change in number of terminal hair bulbs [ Time Frame: Baseline and Day 90 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of terminal hair bulbs over the treatment period.
  • Change in number of terminal hairs [ Time Frame: Baseline and Day 90 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of terminal hairs over the treatment period.
  • Change in number of anagen hairs [ Time Frame: Baseline and Day 90 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of anagen hairs over the treatment period.
  • Change in number of telogen hairs [ Time Frame: Baseline and Day 90 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of telogen hairs over the treatment period.
  • Change in number of vellus (vellus-like) miniaturized hairs [ Time Frame: Baseline and Day 90 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of vellus (vellus-like) miniaturized hairs over the treatment period.
  • Change in number of indeterminate hairs [ Time Frame: Baseline and Day 90 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of indeterminate hairs over the treatment period.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • Change in number of terminal hair follicles [ Time Frame: Baseline, Day 91 and Day 135 ]
    Scalp biopsies obtained prior to initiating therapy, after 90 days of therapy, and after an additional 45 days off therapy will be compared to determine the change in the number of terminal hair follicles over the treatment and off-treatment periods.
  • Change in number of anagen hair follicles [ Time Frame: Baseline, Day 91 and Day 135 ]
    Scalp biopsies obtained prior to initiating therapy, after 90 days of therapy, and after an additional 45 days off therapy will be compared to determine the change in the number of anagen hair follicles over the treatment and off-treatment periods.
  • Change in number of telogen hair follicles [ Time Frame: Baseline, Day 91 and Day 135 ]
    Scalp biopsies obtained prior to initiating therapy, after 90 days of therapy, and after an additional 45 days off therapy will be compared to determine the change in the number of telogen hair follicles over the treatment and off-treatment periods.
  • Change in number of catagen hair follicles [ Time Frame: Baseline, Day 91 and Day 135 ]
    Scalp biopsies obtained prior to initiating therapy, after 90 days of therapy, and after an additional 45 days off therapy will be compared to determine the change in the number of catagen hair follicles over the treatment and off-treatment periods.
  • Change in number of vellus (vellus-like) miniaturized hair follicles [ Time Frame: Baseline, Day 91 and Day 135 ]
    Scalp biopsies obtained prior to initiating therapy, after 90 days of therapy, and after an additional 45 days off therapy will be compared to determine the change in the number of vellus (vellus-like) miniaturized hair follicles over the treatment and off-treatment periods.
  • Change in number of indeterminate hair follicles [ Time Frame: Baseline, Day 91 and Day 135 ]
    Scalp biopsies obtained prior to initiating therapy, after 90 days of therapy, and after an additional 45 days off therapy will be compared to determine the change in the number of indeterminate hair follicles over the treatment and off-treatment periods.
  • Change in density of hair follicles [ Time Frame: Baseline, Day 91 and Day 135 ]
    Scalp biopsies obtained prior to initiating therapy, after 90 days of therapy, and after an additional 45 days off therapy will be compared to determine the change in density of hair follicles over the treatment and off-treatment periods.
  • Ratio of terminal to miniaturized hair follicles (indeterminate hair and vellus hair follicles) [ Time Frame: Baseline, Day 91 and Day 135 ]
    Scalp biopsies obtained prior to initiating therapy, after 90 days of therapy, and after an additional 45 days off therapy will be used to determine the ratio of terminal to miniaturized hair follicles during the treatment and off-treatment periods.
  • Change in nuclear expression of beta-catenin [ Time Frame: Baseline, Day 91 and Day 135 ]
    Scalp biopsies obtained prior to initiating therapy, after 90 days of therapy, and after an additional 45 days off therapy will be compared to determine the change in nuclear expression of beta-catenin over the treatment and off-treatment periods.
  • Change in Ki-67 index in epidermis and hair follicles [ Time Frame: Baseline, Day 91 and Day 135 ]
    Scalp biopsies obtained prior to initiating therapy, after 90 days of therapy, and after an additional 45 days off therapy will be compared to determine the change in Ki-67 index in epidermis and hair follicles over the treatment and off-treatment periods.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2015)
  • Change in density of hair follicles [ Time Frame: Baseline and Day 90 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in density of hair follicles over the treatment period.
  • Ratio of terminal to miniaturized hairs (indeterminate hairs and vellus hairs) [ Time Frame: Baseline and Day 90 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be used to determine the ratio of terminal to miniaturized hairs at Baseline and Day 90.
  • Change in nuclear expression of beta-catenin [ Time Frame: Baseline and Day 90 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in nuclear expression of beta-catenin over the treatment period.
  • Change in nuclear expression of Ki-67 and Ki-67 index in epidermis and hair follicles [ Time Frame: Baseline and Day 90 ]
    Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in nuclear expression of Ki-67 and Ki-67 index in epidermis and hair follicles over the treatment period.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing
Official Title  ICMJE A Phase 2, Multicenter, Randomized, Double-Blind Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia (AGA) Analyzed by Biopsy of the Scalp Prior To and Post Dosing
Brief Summary This study will assess the safety, tolerability, and efficacy of SM04554 at concentrations of 0.15% and 0.25%. Improved knowledge of the changes in hair counts and immunohistochemical analysis associated with androgenetic alopecia (AGA) before and after treatment with SM04554 and compared to placebo may lead to a greater understanding of the underlying mechanisms of action of SM04554.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE
  • Drug: Topical SM04554 solution
  • Drug: Topical Vehicle solution
Study Arms  ICMJE
  • Experimental: Experimental Arm 1
    Topical SM04554 0.15% solution, once daily for approximately 90 days
    Intervention: Drug: Topical SM04554 solution
  • Experimental: Experimental Arm 2
    Topical SM04554 0.25% solution, once daily for approximately 90 days
    Intervention: Drug: Topical SM04554 solution
  • Placebo Comparator: Vehicle
    Topical vehicle solution, once daily for approximately 90 days
    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 Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2016)
49
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2015)
50
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of AGA with Norwood-Hamilton Classification score of 4, 5, 5A, 5V, or 6
  • In good general health, as determined by the Investigator
  • Willing and able to attend all study visits
  • Willing to undergo two punch biopsies of the scalp
  • 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 not use permanent or semi-permanent hair products (e.g., color, texturizers, relaxers) for the duration of the study; daily styling products will be allowed on non-study visit days (e.g., hair gel, mousse, styling spray)
  • Willing to use sponsor-supplied shampoo and conditioner in place of regular shampoo and conditioner, for the duration of the study; use of sponsor-supplied conditioner is optional for subjects who do not use conditioner

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 a highly effective method of birth control and are not willing to use a highly 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, eczema, sun damage, seborrheic dermatitis, actinic keratosis), cuts and/or abrasions on the scalp or hands or condition (e.g., sunburn, tattoos) on the treatment area or hands that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations
  • History of or current skin cancer (e.g., melanoma, basal cell carcinoma, squamous cell carcinoma) located anywhere on the body
  • History of surgical correction of hair loss on the scalp
  • Previous exposure to SM04554
  • Use of blood thinners (e.g., Coumadin, Plavix, Lovenox, and aspirin >81mg); low dose aspirin (e.g., ≤81 mg) is allowable
  • Use of any products or devices clinically proven to promote scalp hair growth (e.g., finasteride or minoxidil) within 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
  • Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30 days prior to study start
  • Use of medicated shampoo or conditioner (medicated shampoo and conditioner refer 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 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
  • Poor peripheral venous access
  • 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
  • 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 any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older 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 NCT02503137
Other Study ID Numbers  ICMJE SM04554-AGA-04
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 February 2020

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