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
Recruitment status was Active, not recruiting
Sponsor:
Neosil, Inc.
Information provided by:
Neosil, Inc.
ClinicalTrials.gov Identifier:
NCT00471510
First received: May 8, 2007
Last updated: May 16, 2008
Last verified: May 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Androgenetic Alopecia |
Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Neosil, Inc.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 140 |
| Study Start Date: | May 2007 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
NEOSH101 2%
|
Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
|
|
Experimental: 2
NEOSH101 1%
|
Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
|
|
Experimental: 3
NEOSH101 0.5%
|
Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
|
| Placebo Comparator: 4 |
Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471510
Locations
| Germany | |
| bioskin Institute for Dermatological Research and Development GmbH | |
| Hamburg, Germany, 20095 | |
Sponsors and Collaborators
Neosil, Inc.
Investigators
| Principal Investigator: | Johannes Gassmueller, MD | bioskin Institute for Dermatological Research and Development GmbH |
More Information
No publications provided
| Responsible Party: | Andria Langeberg, MD, Vice President, Clinical Development, Neosil, Inc. |
| ClinicalTrials.gov Identifier: | NCT00471510 History of Changes |
| Other Study ID Numbers: | NEOSH101-CLIN-AGA004 |
| Study First Received: | May 8, 2007 |
| Last Updated: | May 16, 2008 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Neosil, Inc.:
|
androgenetic alopecia male pattern hair loss male pattern baldness androgenetic alopecia or male pattern hair loss |
Additional relevant MeSH terms:
|
Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 22, 2013