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

NCT ID: NCT00471510

Last Updated: 2008-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31

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.

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

NEOSH101 2%

Group Type: EXPERIMENTAL

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Intervention Type: DRUG

Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

2

NEOSH101 1%

Group Type: EXPERIMENTAL

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Intervention Type: DRUG

Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

3

NEOSH101 0.5%

Group Type: EXPERIMENTAL

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Intervention Type: DRUG

Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

4

Group Type: PLACEBO_COMPARATOR

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Intervention Type: DRUG

Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

Interventions

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Neosil, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Neosil, Inc.

Principal Investigators

Johannes Gassmueller, MD

Role: PRINCIPAL_INVESTIGATOR

bioskin Institute for Dermatological Research and Development GmbH

Locations

bioskin Institute for Dermatological Research and Development GmbH

Hamburg, , Germany

Countries

Germany

Other Identifiers

NEOSH101-CLIN-AGA004

Identifier Type: -

Identifier Source: org_study_id