Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

Phase 2

Completed

• Conditions: Androgenetic Alopecia
• Interventions: Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

• Registration Number: NCT00418730
• Lead Sponsor: Neosil, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-03
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-05
• Primary Completion: 2007-10
• Study Completion: 2008-04
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-16
• Last Update Posted: 2008-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	tetrapeptide aldehyde proteasome inhibitor (NEOSH101)	-
2	tetrapeptide aldehyde proteasome inhibitor (NEOSH101)	-
3	tetrapeptide aldehyde proteasome inhibitor (NEOSH101)	-

Primary Outcome Measures

Name	Time	Method
Hair density, hair growth rate, hair diameter as measured using the TrichoScan method	Through Study Day 197

Secondary Outcome Measures

Name	Time	Method
Assessment score of dermal tolerability	Through Study Day 197
Physician's global assessment score	Through Study Day 197

Trial Locations

Locations (1)

bioskin Institute for Dermatological Research and Development GmbH; 🇩🇪 Hamburg, Germany