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 measure the hair growth response to topical NEOSH101 when applied twice daily to the balding scalp for 16 weeks. One hundred eighty men with Norwood/Hamilton grades III-IV with thinning in the top and center of the scalp will participate. Three equally sized treatment groups (60 men each) will receive either topical NEOSH101 2.0%, minoxidil 5%, or placebo.
Interventions
Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days
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
* Caucasian men, in general good health, aged 18-49 years * Norwood/Hamilton grades III-IV, 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 start, finasteride treatment in the 12 months prior to study start, or treatment with other investigational hair growth products in the 6 months prior to study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hair density, hair growth rate, hair diameter as measured using the TrichoScan method | Through Study Day 197 |
Secondary
| Measure | Time frame |
|---|---|
| Assessment score of dermal tolerability | Through Study Day 197 |
| Physician's global assessment score | Through Study Day 197 |
Countries
Germany
Outcome results
None listed