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| Descriptive Information Fields | |||||||||
| 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 | ||||||||
| Brief Summary | The purpose of this study is to determine if immunophilin ligands may have the potential to reverse hair loss. |
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| 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. |
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| Study Phase | Phase I | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Non-Randomized, Open Label, Placebo Control, Factorial Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | The average number of terminal hairs per graft will be compared between the control and the treated group. | ||||||||
| Secondary Outcome Measure † | 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. | ||||||||
| Condition † | Alopecia | ||||||||
| Intervention † | Drug: FK506, GP11046, GP11511 | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 35 | ||||||||
| Start Date † | July 2003 | ||||||||
| Completion Date | September 2004 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00177099 | ||||||||
| Organization ID | 0306M49486 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Hordinsky, Maria K., MD | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | University of Minnesota | ||||||||
| Verification Date | November 2006 | ||||||||
| First Received Date † | September 13, 2005 | ||||||||
| Last Updated Date | November 8, 2006 | ||||||||
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