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

• ClinicalTrials.gov Identifier: NCT02275351
• Recruitment Status: Completed
• First Posted: October 27, 2014
• Last Update Posted: February 17, 2020
• Sponsor: Biosplice Therapeutics, Inc.
• Information provided by (Responsible Party): Biosplice Therapeutics, Inc.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Androgenetic Alopecia	Drug: SM04554; Drug: Vehicle	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 310 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: November 2014
• Actual Primary Completion Date: November 2015
• Actual Study Completion Date: November 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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).
2. 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.
3. 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, California

Encinitas, California, United States, 92024

San Diego, California, United States, 92123

United States, Connecticut

New Haven, Connecticut, United States, 06511

United States, Florida

Miami, Florida, United States, 33143

West Palm Beach, Florida, United States, 33401

United States, Indiana

Plainfield, Indiana, United States

United States, Kansas

Wichita, Kansas, United States, 67207

United States, Michigan

Clinton Township, Michigan, United States, 48038

Detroit, Michigan, United States, 48202

United States, Minnesota

Fridley, Minnesota, United States, 55432

United States, New Mexico

Albuquerque, New Mexico, United States, 87106

United States, New York

New York, New York, United States

Stony Brook, New York, United States, 11790

United States, North Carolina

Winston-Salem, North Carolina, United States, 27104

United States, Ohio

Cleveland, Ohio, United States, 44195

United States, Oregon

Portland, Oregon, United States, 97210

Portland, Oregon, United States, 97223

United States, Texas

Austin, Texas, United States, 78759

College Station, Texas, United States, 77845

Dallas, Texas, United States, 75246

Houston, Texas, United States

United States, Utah

Salt Lake City, Utah, United States, 84117

United States, Virginia

Lynchburg, Virginia, United States, 24501

Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Biosplice Therapeutics, Inc.

Investigators

• Study Director: Yusuf Yazici, M.D.; Biosplice Therapeutics, Inc.

More Information

• Responsible Party: Biosplice Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02275351
• Other Study ID Numbers: SM04554-AGA-02
• First Posted: October 27, 2014
• Last Update Posted: February 17, 2020
• Last Verified: February 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biosplice Therapeutics, Inc.:

alopecia; topical; Samumed

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical