Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

NCT00418730 | Completed Phase 2

• 1 other identifier: NEOSH101-CLIN-AGA003
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Androgenetic Alopecia

Keywords

androgenetic alopecia; male pattern hair loss; male pattern baldness; androgenetic alopecia or male pattern hair loss

Outcome Measures

Primary Outcomes (1)

• Hair density, hair growth rate, hair diameter as measured using the TrichoScan method

  Through Study Day 197

Secondary Outcomes (2)

• Assessment score of dermal tolerability

  Through Study Day 197

• Physician's global assessment score

  Through Study Day 197

Study Arms (3)

1

EXPERIMENTAL

Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

2

ACTIVE COMPARATOR

Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

3

PLACEBO COMPARATOR

Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Interventions

tetrapeptide aldehyde proteasome inhibitor (NEOSH101) DRUG

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

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian men, in general good health, aged 18-49 years
• Norwood/Hamilton grades III-IV, with thinning hair in the vertex area

You may not qualify if:

• 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

Sponsors & Collaborators

• Neosil, Inc.: lead

Study Sites (1)

bioskin Institute for Dermatological Research and Development GmbH

Hamburg, 20095, Germany

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Johannes Gassmueller, MD

  Bioskin GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 3, 2007
• First Posted: January 5, 2007
• Study Start: January 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: April 1, 2008
• Last Updated: May 20, 2008

Record last verified: 2008-05

Locations

DE (1)