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Effects of Ligands on Human Hair Follicles Grafted Onto SCID Mice

NCT ID: NCT00177099

Last Updated: 2006-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2004-09-30

Brief Summary

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The purpose of this study is to determine if immunophilin ligands may have the potential to reverse hair loss.

Detailed Description

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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.

Conditions

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Alopecia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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FK506, GP11046, GP11511

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy men ages 18-65 with Hamilton type IV or V alopecia
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hordinsky, Maria K., MD

INDIV

Sponsor Role lead

Principal Investigators

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Marna Ericson, Ph D

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Maria Hordinsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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0306M49486

Identifier Type: -

Identifier Source: org_study_id