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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Neosil, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Neosil, Inc.
ClinicalTrials.gov Identifier:
NCT00471510
First received: May 8, 2007
Last updated: May 16, 2008
Last verified: May 2008

May 8, 2007
May 16, 2008
May 2007
February 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00471510 on ClinicalTrials.gov Archive Site
  • Assessment score of dermal tolerability [ Time Frame: 16 weeks application treatment period followed by 12 weeks observation period ] [ Designated as safety issue: Yes ]
  • Physician's global assessment score [ Time Frame: 16 weeks application treatment period followed by 12 weeks observation period ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Dose-Ranging Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Androgenetic Alopecia
Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
Not Provided
February 2008   (final data collection date for primary outcome measure)

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
Male
18 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00471510
NEOSH101-CLIN-AGA004
No
Andria Langeberg, MD, Vice President, Clinical Development, Neosil, Inc.
Neosil, Inc.
Not Provided
Principal Investigator: Johannes Gassmueller, MD bioskin Institute for Dermatological Research and Development GmbH
Neosil, Inc.
May 2008

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