Androgenetic Alopecia
Conditions
Keywords
androgenetic alopecia, male pattern hair loss, male pattern baldness, androgenetic alopecia or male pattern hair loss
Brief summary
The purpose of this study is to evaluate the safety and efficacy of three doses of topical NEOSH101 applied once-daily (qd) for 16 weeks in men with thinning hair in the top and center of the scalp (Norwood/Hamilton grades III-IV androgenetic alopecia). Four equally sized treatment groups (35 men each) will receive either NEOSH101 0.5%, NEOSH101 1.0%, NEOSH101 2.0% or placebo. A 12-week observation period will follow the treatment period.
Interventions
Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
Sponsors
Neosil, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Men, aged 18 to 49 years, in general good health * Norwood/Hamilton grades III - IV androgenetic alopecia, with thinning hair in the vertex area
Exclusion criteria
* Concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug * Treatment with a systemic or locally acting medication which may interfere with the study objectives, such as minoxidil treatment in the 6 months prior to study day 1, finasteride treatment in the 12 months prior to study day 1, or treatment with other investigational hair growth products in the 6 months prior to study day 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hair density, hair growth rate, hair diameter as measured using the Trichoscan method | 16 weeks application treatment period followed by 12 weeks observation period |
Secondary
| Measure | Time frame |
|---|---|
| Assessment score of dermal tolerability | 16 weeks application treatment period followed by 12 weeks observation period |
| Physician's global assessment score | 16 weeks application treatment period followed by 12 weeks observation period |
Countries
Germany
Outcome results
None listed