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
  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
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: 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 July 22, 2014