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Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream

NCT01345526 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2021-04-30

No results posted yet for this study

Summary

The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients receiving first line cetuximab treatment.

Conditions

Interventions

DEVICE

Reconval K1 Cream

DEVICE

Reconval Cream

Sponsors & Collaborators

  • Universitätsmedizin Mannheim

    lead OTHER

Principal Investigators

  • Ralf Hofheinz, Prof. · Universitätsmedizin Mannheim

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Germany
  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

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 NCT01345526 on ClinicalTrials.gov