Effects of Ligands on Human Hair Follicles Grafted Onto SCID Mice - Full Text View

Sponsored by:	Hordinsky, Maria K., MD
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00177099

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Neurotrophic Effects of Immunophilin Ligands on Human Hair Follicles Grafted Onto Service Combined Immunodeficient (SCID) Mice

Resource links provided by NLM:

MedlinePlus related topics: Hair Diseases and Hair Loss

U.S. FDA Resources

Further study details as provided by University of Minnesota:

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
Principal Investigator:	Maria Hordinsky, MD	University of Minnesota

More Information

No publications provided

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

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hypotrichosis
Skin Diseases

Alopecia
Tacrolimus
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hair Diseases
Hypotrichosis
Skin Diseases
Alopecia

ClinicalTrials.gov processed this record on July 02, 2009