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

Completed · Phase 2

Conditions studied: Androgenetic Alopecia

In brief

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).

Key facts

Study ID

NCT02275351

Run by

Biosplice Therapeutics, Inc.

People needed

310

Starts

2014-11-01

Expected to finish

2015-11-01

Last updated by the study team

2020-02-17

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Study site — Encinitas, California, United States
• Study site — San Diego, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Miami, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Plainfield, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Clinton Township, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Fridley, Minnesota, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Stony Brook, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Austin, Texas, United States
• Study site — College Station, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Lynchburg, Virginia, United States
• Study site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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