Effects of Ligands on Human Hair Follicles Grafted Onto S... | NCT00177099

Studies
Effects of Ligands on Human Hair Follicles Grafted Onto SCID Mice

NCT00177099

Sponsor

Hordinsky, Maria K., MD

Status

Completed

Last Update Posted

Nov 13, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Alopecia

Interventions

FK506, GP11046, GP11511

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Not provided

Completion Date

Sep 2004

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2006

Last Update Posted Date

Nov 13, 2006Estimated

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
FK506, GP11046, GP11511	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The average number of terminal hairs per graft will be compared between the control and the treated group.

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marna Ericson, Ph D	University of Minnesota	Principal Investigator
Maria Hordinsky, MD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States

Condition Browse Module

MeSH Terms

ID	Term
D000505	Alopecia

Ancestor Terms

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016559	Tacrolimus

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided