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

Androgenetic Alopecia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00471510
• Other study ID #: NEOSH101-CLIN-AGA004
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 8, 2007
• Last updated: May 16, 2008
• Start date: May 2007

Study information

• Verified date: May 2008
• Source: Neosil, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Drug:
• tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

Locations

Country	Name	City	State
Germany	bioskin Institute for Dermatological Research and Development GmbH	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Neosil, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair density, hair growth rate, hair diameter as measured using the Trichoscan method		16 weeks application treatment period followed by 12 weeks observation period	No
Secondary	Assessment score of dermal tolerability		16 weeks application treatment period followed by 12 weeks observation period	Yes
Secondary	Physician's global assessment score		16 weeks application treatment period followed by 12 weeks observation period	No