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

NCT00471510 | Unknown Phase 2

• 1 other identifier: NEOSH101-CLIN-AGA004
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

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

  16 weeks application treatment period followed by 12 weeks observation period

Secondary Outcomes (2)

• 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

Study Arms (4)

1

EXPERIMENTAL

NEOSH101 2%

Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

2

EXPERIMENTAL

NEOSH101 1%

Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

3

EXPERIMENTAL

NEOSH101 0.5%

Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

4

PLACEBO COMPARATOR

Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Interventions

tetrapeptide aldehyde proteasome inhibitor (NEOSH101) DRUG

Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks

1; 2; 3; 4

Eligibility Criteria

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

You may qualify if:

• Men, aged 18 to 49 years, in general good health
• Norwood/Hamilton grades III - IV androgenetic alopecia, 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 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

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 Institute for Dermatological Research and Development 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: May 8, 2007
• First Posted: May 10, 2007
• Study Start: May 1, 2007
• Primary Completion: February 1, 2008
• Last Updated: May 20, 2008

Record last verified: 2008-05

Locations

DE (1)