Clinical trial NCT02275351: A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Androgenetic Alopecia
Keywords: alopecia
topical
Samumed
Lead sponsor: Biosplice Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 310
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Change in non-vellus hair count
timeFrame: Baseline, Day 45, Day 90
measure: Change in subject assessment of hair growth and quality
timeFrame: Day 45, Day 90
Secondary outcomes:
measure: Change in hair growth as assessed by the investigator
timeFrame: Day 45, Day 90
measure: Impact of AGA on quality of life
timeFrame: Baseline, Day 45, Day 90
measure: Change in hair density
timeFrame: Baseline, Day 45, Day 90
Other outcomes:
Locations:
city: Encinitas
country: United States
state: California
city: San Diego
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Miami
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Plainfield
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Clinton Township
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Lynchburg
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Biosplice Therapeutics, Inc.
name: Yusuf Yazici, M.D.
role: STUDY_DIRECTOR
References: