Dose-Ranging Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

Neosil

Status and phase: Unknown; Phase 2

Conditions: Androgenetic Alopecia

Treatments: Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00471510

NEOSH101-CLIN-AGA004

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: Male

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

NEOSH101 2%

Treatment:

Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

2

Experimental group

Description:

NEOSH101 1%

Treatment:

Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

3

Experimental group

Description:

NEOSH101 0.5%

Treatment:

Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

4

Placebo Comparator group

Treatment:

Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)