Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

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Brief Title

Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

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

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Assessment score of dermal tolerability

Condition

Androgenetic Alopecia

Intervention

tetrapeptide aldehyde proteasome inhibitor (NEOSH101)

Study Arms / Comparison Groups

 1
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

180

Start Date

January 2007

Completion Date

April 2008

Primary Completion Date

October 2007

Eligibility Criteria

        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

Male

Ages

18 Years - 49 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Johannes Gassmueller, MD, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00418730

Organization ID

NEOSH101-CLIN-AGA003



Study Sponsor

Neosil, Inc.


Study Sponsor

Johannes Gassmueller, MD, Principal Investigator, Bioskin GmbH


Verification Date

May 2008