NCT00177099

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

November 13, 2006

Status Verified

November 1, 2006

First QC Date

September 13, 2005

Last Update Submit

November 8, 2006

Conditions

Alopecia

Outcome Measures

Primary Outcomes (1)

  • The average number of terminal hairs per graft will be compared between the control and the treated group.

Secondary Outcomes (1)

  • 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.

Interventions

FK506, GP11046, GP11511DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Marna Ericson, Ph D

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Maria Hordinsky, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDIV

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

July 1, 2003

Study Completion

September 1, 2004

Last Updated

November 13, 2006

Record last verified: 2006-11

Locations

US(1)