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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00471510
Recruitment Status : Unknown
Verified May 2008 by Neosil, Inc..
Recruitment status was:  Active, not recruiting
First Posted : May 10, 2007
Last Update Posted : May 20, 2008
Sponsor:
Information provided by:
Neosil, Inc.

Tracking Information
First Submitted Date  ICMJE May 8, 2007
First Posted Date  ICMJE May 10, 2007
Last Update Posted Date May 20, 2008
Study Start Date  ICMJE May 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2007)
Hair density, hair growth rate, hair diameter as measured using the Trichoscan method [ Time Frame: 16 weeks application treatment period followed by 12 weeks observation period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2007)
  • Assessment score of dermal tolerability [ Time Frame: 16 weeks application treatment period followed by 12 weeks observation period ]
  • Physician's global assessment score [ Time Frame: 16 weeks application treatment period followed by 12 weeks observation period ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Ranging Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss
Official Title  ICMJE A Phase 2 Multicenter, Randomized, Placebo-Controlled, Parallel Group Dose-Ranging 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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
Study Arms  ICMJE
  • Experimental: 1
    NEOSH101 2%
    Intervention: Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
  • Experimental: 2
    NEOSH101 1%
    Intervention: Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
  • Experimental: 3
    NEOSH101 0.5%
    Intervention: Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
  • Placebo Comparator: 4
    Intervention: Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: May 8, 2007)
140
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men, aged 18 to 49 years, in general good health
  • Norwood/Hamilton grades III - IV androgenetic alopecia, 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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00471510
Other Study ID Numbers  ICMJE NEOSH101-CLIN-AGA004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andria Langeberg, MD, Vice President, Clinical Development, Neosil, Inc.
Study Sponsor  ICMJE Neosil, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Johannes Gassmueller, MD bioskin Institute for Dermatological Research and Development GmbH
PRS Account Neosil, Inc.
Verification Date May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP