Overview

This trial is active, not recruiting.

Condition androgenetic alopecia
Treatment tetrapeptide aldehyde proteasome inhibitor (neosh101)
Phase phase 2
Sponsor Neosil, Inc.
Start date May 2007
End date February 2008
Trial size 140 participants
Trial identifier NCT00471510, NEOSH101-CLIN-AGA004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
NEOSH101 2%
tetrapeptide aldehyde proteasome inhibitor (neosh101)
Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
(Experimental)
NEOSH101 1%
tetrapeptide aldehyde proteasome inhibitor (neosh101)
Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
(Experimental)
NEOSH101 0.5%
tetrapeptide aldehyde proteasome inhibitor (neosh101)
Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
(Placebo Comparator)
tetrapeptide aldehyde proteasome inhibitor (neosh101)
Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

Primary Outcomes

Measure
Hair density, hair growth rate, hair diameter as measured using the Trichoscan method
time frame: 16 weeks application treatment period followed by 12 weeks observation period

Secondary Outcomes

Measure
Assessment score of dermal tolerability
time frame: 16 weeks application treatment period followed by 12 weeks observation period
Physician's global assessment score
time frame: 16 weeks application treatment period followed by 12 weeks observation period

Eligibility Criteria

Male participants from 18 years up to 49 years old.

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

Additional Information

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
Principal investigator Johannes Gassmueller, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Neosil, Inc..