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Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

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ClinicalTrials.gov Identifier: NCT00418730
Recruitment Status : Completed
First Posted : January 5, 2007
Last Update Posted : May 20, 2008
Sponsor:
Information provided by:
Neosil, Inc.

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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Hair density, hair growth rate, hair diameter as measured using the TrichoScan method [ Time Frame: Through Study Day 197 ]

Secondary Outcome Measures :
  1. Assessment score of dermal tolerability [ Time Frame: Through Study Day 197 ]
  2. Physician's global assessment score [ Time Frame: Through Study Day 197 ]


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 5, 2007    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008

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