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Effects of Ligands on Human Hair Follicles Grafted Onto SCID Mice

This study has been completed.
Sponsor:
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00177099
First received: September 13, 2005
Last updated: November 8, 2006
Last verified: November 2006
History of Changes
  Purpose

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


Condition Intervention Phase
Alopecia
 Drug: FK506, GP11046, GP11511
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neurotrophic Effects of Immunophilin Ligands on Human Hair Follicles Grafted Onto Service Combined Immunodeficient (SCID) Mice

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

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.

Estimated Enrollment: 35
Study Start Date: July 2003
Estimated Study Completion Date: September 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177099

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Hordinsky, Maria K., MD
Investigators
Principal Investigator: Marna Ericson, Ph D University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Maria Hordinsky, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00177099     History of Changes
Other Study ID Numbers: 0306M49486
Study First Received: September 13, 2005
Last Updated: November 8, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013