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

Sponsor

Neosil, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00471510

Collaborator

(none)

140

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Androgenetic Alopecia	Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Multicenter, Randomized, Placebo-Controlled, Parallel Group Dose-Ranging Study to Evaluate the Safety and Efficacy of Topical NEOSH101 in the Treatment of Androgenetic Alopecia in Men

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 NEOSH101 2%	Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
Experimental: 2 NEOSH101 1%	Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
Experimental: 3 NEOSH101 0.5%	Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
Placebo Comparator: 4	Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

Outcome Measures

Primary Outcome Measures

Hair density, hair growth rate, hair diameter as measured using the Trichoscan method [16 weeks application treatment period followed by 12 weeks observation period]

Secondary Outcome Measures

Assessment score of dermal tolerability [16 weeks application treatment period followed by 12 weeks observation period]
Physician's global assessment score [16 weeks application treatment period followed by 12 weeks observation period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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