Back to resultsEffects of Ligands on Human Hair Follicles Grafted Onto SCID Mice
Primary Purpose
Alopecia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FK506, GP11046, GP11511
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia
Eligibility Criteria
Inclusion Criteria: Healthy men ages 18-65 with Hamilton type IV or V alopecia Exclusion Criteria: Individuals who do not meet the inclusion criteria.
Sites / Locations
- University of Minnesota
Outcomes
Primary Outcome Measures
The average number of terminal hairs per graft will be compared between the control and the treated group.
Secondary Outcome Measures
The number of follicles in anagen, catagen and telogen per graft will be averaged for each group. The results will be compared between the control and the treated groups.
Full Information
NCT ID
NCT00177099
First Posted
September 13, 2005
Last Updated
November 8, 2006
Sponsor
Hordinsky, Maria K., MD
1. Study Identification
Unique Protocol Identification Number
NCT00177099
Brief Title
Effects of Ligands on Human Hair Follicles Grafted Onto SCID Mice
Official Title
Neurotrophic Effects of Immunophilin Ligands on Human Hair Follicles Grafted Onto Service Combined Immunodeficient (SCID) Mice
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hordinsky, Maria K., MD
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine if immunophilin ligands may have the potential to reverse hair loss.
Detailed Description
Preliminary experiments in C57BL/6J mice showed that immunophilin ligand FK506 and its non-immunosuppressive analogs, GP11046 and GP11511 were capable of promoting telogen to anagen transition. Since GP11046 and GP11511 possess the neurotrophic properties of FK506 without its immunosuppressant capability, the neural action of these immunophilin ligands may play an important role in the hair cycle. This finding has significant clinical implications in that immunophilin ligands may have the potential to reverse alopecia. To further investigate this possibility we propose to explore the response of transplanted miniaturized scalp hair follicles to topically applied immunophilin ligands.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
FK506, GP11046, GP11511
Primary Outcome Measure Information:
Title
The average number of terminal hairs per graft will be compared between the control and the treated group.
Secondary Outcome Measure Information:
Title
The number of follicles in anagen, catagen and telogen per graft will be averaged for each group. The results will be compared between the control and the treated groups.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy men ages 18-65 with Hamilton type IV or V alopecia
Exclusion Criteria:
Individuals who do not meet the inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marna Ericson, Ph D
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Hordinsky, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Ligands on Human Hair Follicles Grafted Onto SCID Mice
We'll reach out to this number within 24 hrs