Effects of Ligands on Human Hair Follicles Grafted Onto SCID Mice

Alopecia Clinical Trial

Official title:

Neurotrophic Effects of Immunophilin Ligands on Human Hair Follicles Grafted Onto Service Combined Immunodeficient (SCID) Mice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177099
• Other study ID #: 0306M49486
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: November 8, 2006
• Start date: July 2003
• Est. completion date: September 2004

Study information

• Verified date: November 2006
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy men ages 18-65 with Hamilton type IV or V alopecia

Exclusion Criteria:

• Individuals who do not meet the inclusion criteria.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia

Intervention

Drug:
• FK506, GP11046, GP11511

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Hordinsky, Maria K., MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average number of terminal hairs per graft will be compared between the control and the treated group.
Secondary	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.