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

NCT02275351 | Completed Phase 2 FDA Drug

• 1 other identifier: SM04554-AGA-02
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 24

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).

Conditions

Androgenetic Alopecia

Keywords

alopecia; topical; Samumed

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in hair growth as assessed by the investigator

  Day 45, Day 90

• Impact of AGA on quality of life

  Baseline, Day 45, Day 90

• Change in hair density

  Baseline, Day 45, Day 90

Study Arms (3)

Active Arm 1

EXPERIMENTAL

Topical SM04554 0.15% solution, applied once a day for 90 days

Drug: SM04554

Active Arm 2

EXPERIMENTAL

Topical SM04554 0.25% solution, applied once a day for 90 days

Drug: SM04554

Vehicle Arm

PLACEBO COMPARATOR

Topical vehicle solution, applied once a day for 90 days

Drug: Vehicle

Interventions

SM04554 DRUG

Topical solution, applied once a day

Active Arm 1; Active Arm 2

Vehicle DRUG

Topical solution, applied once a day

Vehicle Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Biosplice Therapeutics, Inc.: lead

Study Sites (24)

Unknown Facility

Encinitas, California, 92024, United States

Location

Unknown Facility

San Diego, California, 92123, United States

Location

Unknown Facility

New Haven, Connecticut, 06511, United States

Location

Unknown Facility

Miami, Florida, 33143, United States

Location

Unknown Facility

West Palm Beach, Florida, 33401, United States

Location

Unknown Facility

Plainfield, Indiana, United States

Location

Unknown Facility

Wichita, Kansas, 67207, United States

Location

Unknown Facility

Clinton Township, Michigan, 48038, United States

Location

Unknown Facility

Detroit, Michigan, 48202, United States

Location

Unknown Facility

Fridley, Minnesota, 55432, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87106, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Stony Brook, New York, 11790, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27104, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Portland, Oregon, 97210, United States

Location

Unknown Facility

Portland, Oregon, 97223, United States

Location

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Austin, Texas, 78759, United States

Location

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College Station, Texas, 77845, United States

Location

Unknown Facility

Dallas, Texas, 75246, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, 84117, United States

Location

Unknown Facility

Lynchburg, Virginia, 24501, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 27, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

US (24)