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

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)

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).

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: SM04554; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
    • San Diego, California, United States, 92123
  • Connecticut
    • New Haven, Connecticut, United States, 06511
  • Florida
    • Miami, Florida, United States, 33143
    • West Palm Beach, Florida, United States, 33401
  • Indiana
    • Plainfield, Indiana, United States
  • Kansas
    • Wichita, Kansas, United States, 67207
  • Michigan
    • Clinton Township, Michigan, United States, 48038
    • Detroit, Michigan, United States, 48202
  • Minnesota
    • Fridley, Minnesota, United States, 55432
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
  • New York
    • New York, New York, United States
    • Stony Brook, New York, United States, 11790
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27104
  • Ohio
    • Cleveland, Ohio, United States, 44195
  • Oregon
    • Portland, Oregon, United States, 97210
    • Portland, Oregon, United States, 97223
  • Texas
    • Austin, Texas, United States, 78759
    • College Station, Texas, United States, 77845
    • Dallas, Texas, United States, 75246
    • Houston, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States, 84117
  • Virginia
    • Lynchburg, Virginia, United States, 24501
    • Norfolk, Virginia, United States, 23507

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Arm 1; Topical SM04554 0.15% solution, applied once a day for 90 days	Drug: SM04554; Topical solution, applied once a day
Experimental: Active Arm 2; Topical SM04554 0.25% solution, applied once a day for 90 days	Drug: SM04554; Topical solution, applied once a day
Placebo Comparator: Vehicle Arm; Topical vehicle solution, applied once a day for 90 days	Drug: Vehicle; Topical solution, applied once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in non-vellus hair count	Change in non-vellus hair count over time as compared to Baseline. Non-vellus hair count will be determined by macrophotography.	Baseline, Day 45, Day 90
Change in subject assessment of hair growth and quality	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.	Day 45, Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hair growth as assessed by the investigator	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).	Day 45, Day 90
Impact of AGA on quality of life	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.	Baseline, Day 45, Day 90
Change in hair density	Change in hair density over time as compared to Baseline. Hair density will be measured using macrophotography.	Baseline, Day 45, Day 90

Collaborators and Investigators

• Sponsor: Biosplice Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: October 24, 2014
• First Posted (Estimate): October 27, 2014

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: topical; alopecia; Samumed
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: SM04554-AGA-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No