Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

This study has been completed.
Sponsor:
Information provided by:
Neosil, Inc.
ClinicalTrials.gov Identifier:
NCT00418730
First received: January 3, 2007
Last updated: May 16, 2008
Last verified: May 2008
  Purpose

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.


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- 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

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: Through Study Day 197 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment score of dermal tolerability [ Time Frame: Through Study Day 197 ] [ Designated as safety issue: Yes ]
  • Physician's global assessment score [ Time Frame: Through Study Day 197 ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: January 2007
Study Completion Date: April 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days
Active Comparator: 2 Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days
Placebo Comparator: 3 Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418730

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 GmbH
  More Information

No publications provided

Responsible Party: Andria Langenberg, MD, Vice President, Clinical Development, Neosil, Inc.
ClinicalTrials.gov Identifier: NCT00418730     History of Changes
Other Study ID Numbers: NEOSH101-CLIN-AGA003
Study First Received: January 3, 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
Proteasome Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014