Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418730
• Other study ID #: NEOSH101-CLIN-AGA003
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2007
• Last updated: May 16, 2008
• Start date: January 2007
• Est. completion date: April 2008

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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

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, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days

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		Through Study Day 197	No
Secondary	Assessment score of dermal tolerability		Through Study Day 197	Yes
Secondary	Physician's global assessment score		Through Study Day 197	No