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Safety, Tolerability and Efficacy Study of Doxycycline Foam for the Prevention of EGFRI Skin Toxicity in Cancer Patients

NCT02239731 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-02-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of FDX104 Antibiotic Foam in the prevention of EGFRI skin toxicity in cancer patients receiving Cetuximab or Panitumumab.

Conditions

  • Rash Due to Epidermal Growth Factor Receptor Inhibitors

Interventions

DRUG

FDX104 (4% Doxycycline)

FDX104 - 4% or Placebo to be applied twice twice daily during 5 weeks

Sponsors & Collaborators

  • Vyne Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Ravit Geva, MD · Sourasky Medical center, Tel-aviv, Israel

  • Einat Shacham Shmueli, MD · Sheba Medical Center

  • Nirit Yarom, MD · Assaf Harofeh medical center, Beer Yaakov, Israel

  • Valerya Semenysty, MD · Rambam Health Care Campus

  • Ayala Hubert, MD · Hadassah Medical Organization

  • Alexander Gluzman, MD · Soroka University Medical Center

  • Hadas Prag Nave, MD · Rabin Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Israel

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 NCT02239731 on ClinicalTrials.gov