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Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

NCT00832091 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2010-03-30

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers

Conditions

  • Venous Stasis Ulcers

Interventions

DRUG

Thymosin Beta 4

There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days

DRUG

Placebo

There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days

Sponsors & Collaborators

  • sigma-tau i.f.r. S.p.A.

    collaborator INDUSTRY

  • RegeneRx Biopharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Giorgio Guarnera, MD · Istituto Dermopatico Dell'Immacolata, Rome , Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Italy
  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00832091 on ClinicalTrials.gov