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

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

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.

Study Overview

• Status: Unknown
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20095
    • bioskin Institute for Dermatological Research and Development GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Neosil, Inc.
• Investigators: Principal Investigator: Johannes Gassmueller, MD, bioskin Institute for Dermatological Research and Development GmbH

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: May 8, 2007
• First Submitted That Met QC Criteria: May 8, 2007
• First Posted (Estimate): May 10, 2007

Study Record Updates

• Last Update Posted (Estimate): May 20, 2008
• Last Update Submitted That Met QC Criteria: May 16, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: androgenetic alopecia; male pattern hair loss; male pattern baldness; androgenetic alopecia or male pattern hair loss
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Proteasome Inhibitors
• Other Study ID Numbers: NEOSH101-CLIN-AGA004