Skip to main content
OpenTrials
Completed

NCT Number: NCT00418730

Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

bioskin Institute for Dermatological Research and Development GmbH

Hamburg, 20095, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Drug

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

Primary outcomes

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

    Time frame: Through Study Day 197

Secondary outcomes

  1. Assessment score of dermal tolerability

    Time frame: Through Study Day 197

  2. Physician's global assessment score

    Time frame: Through Study Day 197

Sponsors and collaborators

Lead sponsor

Neosil, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Jan 5, 2007
Registry last updated
May 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.