Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2007

Interventions

  • Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
    • Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days

Arms, Groups and Cohorts

  • Experimental: 1
  • Active Comparator: 2
  • Placebo Comparator: 3

Clinical Trial Outcome Measures

Primary Measures

  • Hair density, hair growth rate, hair diameter as measured using the TrichoScan method
    • Time Frame: Through Study Day 197

Secondary Measures

  • Assessment score of dermal tolerability
    • Time Frame: Through Study Day 197
  • Physician’s global assessment score
    • Time Frame: Through Study Day 197

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Neosil, Inc.
  • Provider of Information About this Clinical Study
    • Andria Langenberg, MD, Vice President, Clinical Development, Neosil, Inc.
  • Overall Official(s)
    • Johannes Gassmueller, MD, Principal Investigator, Bioskin GmbH

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