Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

Neosil

Status and phase: Completed; Phase 2

Conditions: Androgenetic Alopecia

Treatments: Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00418730

NEOSH101-CLIN-AGA003

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: Male

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

2

Active Comparator group

Treatment:

Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

3

Placebo Comparator group

Treatment:

Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)