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

NCT02503137 | Completed Phase 2 FDA Drug

• 1 other identifier: SM04554-AGA-04
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 5

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.

Conditions

Androgenetic Alopecia

Keywords

male pattern baldness; SM04554; AGA

Outcome Measures

Primary Outcomes (6)

• Change in number of terminal hair follicles

  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.

  Baseline and Day 91

• Change in number of anagen hair follicles

  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.

  Baseline and Day 91

• Change in number of telogen hair follicles

  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.

  Baseline and Day 91

• Change in number of catagen hair follicles

  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.

  Baseline and Day 91

• Change in number of vellus (vellus-like) miniaturized hair follicles

  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.

  Baseline and Day 91

• Change in number of indeterminate hair follicles

  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.

  Baseline and Day 91

Secondary Outcomes (10)

• Change in number of terminal hair follicles

  Baseline, Day 91 and Day 135

• Change in number of anagen hair follicles

  Baseline, Day 91 and Day 135

• Change in number of telogen hair follicles

  Baseline, Day 91 and Day 135

• Change in number of catagen hair follicles

  Baseline, Day 91 and Day 135

• Change in number of vellus (vellus-like) miniaturized hair follicles

  Baseline, Day 91 and Day 135

Study Arms (3)

Experimental Arm 1

EXPERIMENTAL

Topical SM04554 0.15% solution, once daily for approximately 90 days

Drug: Topical SM04554 solution

Experimental Arm 2

EXPERIMENTAL

Topical SM04554 0.25% solution, once daily for approximately 90 days

Drug: Topical SM04554 solution

Vehicle

PLACEBO COMPARATOR

Topical vehicle solution, once daily for approximately 90 days

Drug: Topical Vehicle solution

Interventions

Topical SM04554 solution DRUG

Experimental Arm 1; Experimental Arm 2

Topical Vehicle solution DRUG

Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosplice Therapeutics, Inc.: lead

Study Sites (5)

Research Site

Clinton Township, Michigan, United States

Location

Research Site

Cleveland, Ohio, United States

Location

Research Site

College Station, Texas, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

Lynchburg, Virginia, United States

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, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 20, 2015
• Study Start: August 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

US (5)