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Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers

NCT00797706 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2010-02-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate if the investigational medicinal product CHRONSEAL intended for future treatment of chronic venous leg ulcers is safe and tolerated and if it has an ulcer size reduction effect when administered to individuals suffering from venous leg ulcers.

Conditions

  • Chronic Venous Leg Ulcers

Interventions

DRUG

CHRONSEAL

Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions

Sponsors & Collaborators

  • Kringle Pharma, Inc.

    collaborator INDUSTRY

  • Kringle Pharma Europe AB

    lead INDUSTRY

Principal Investigators

  • Hans Olav Høivik, MD · Medi 3 Innlandet AS, avd Hamar

  • Karin Andersson, MD · Halland County Council, Department of Dermatology and Infectious diseases, Halmstad, Sweden

  • Jan Apelqvist, Assoc. Prof., PhD, MD · Department of Endocrinology, University Hospital Malmö,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Norway
  • Sweden

Study Locations

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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 NCT00797706 on ClinicalTrials.gov