Back to resultsEfficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss
Primary Purpose
Androgenetic Alopecia
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia focused on measuring androgenetic alopecia, male pattern hair loss, male pattern baldness, androgenetic alopecia or male pattern hair loss
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
Sites / Locations
- bioskin Institute for Dermatological Research and Development GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Hair density, hair growth rate, hair diameter as measured using the TrichoScan method
Secondary Outcome Measures
Assessment score of dermal tolerability
Physician's global assessment score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00418730
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Neosil, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
androgenetic alopecia, male pattern hair loss, male pattern baldness, androgenetic alopecia or male pattern hair loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Intervention Description
Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days
Primary Outcome Measure Information:
Title
Hair density, hair growth rate, hair diameter as measured using the TrichoScan method
Time Frame
Through Study Day 197
Secondary Outcome Measure Information:
Title
Assessment score of dermal tolerability
Time Frame
Through Study Day 197
Title
Physician's global assessment score
Time Frame
Through Study Day 197
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Gassmueller, MD
Organizational Affiliation
Bioskin GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
bioskin Institute for Dermatological Research and Development GmbH
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
12. IPD Sharing Statement
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Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss
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