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

Biosplice Therapeutics

Status and phase: Completed; Phase 2

Conditions: Androgenetic Alopecia

Treatments: Drug: Vehicle; Drug: SM04554

Study type: Interventional

Funder types: Industry

Identifiers

NCT02275351

SM04554-AGA-02

Details and patient eligibility

About

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).

Enrollment: 310 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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310 participants in 3 patient groups, including a placebo group

Active Arm 1

Experimental group

Description:

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

Treatment:

Drug: SM04554

Active Arm 2

Experimental group

Description:

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

Treatment:

Drug: SM04554

Vehicle Arm

Placebo Comparator group

Description:

Topical vehicle solution, applied once a day for 90 days

Treatment:

Drug: Vehicle