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Bepanthen Versus Cetomacrogol in Epidermal Growth Factor Receptor Inhibitors (EGFRI)

NCT01136005 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2017-11-13

No results posted yet for this study

Summary

Objective:

To assess the preemptive effect of Bepanthen® on decreasing the incidence of specific ≥ grade 2 dermatological side effects of interest in respect of compliance to EGFRI agents, HRQoL and the adherence during the 6-week skin treatment period. The adherence to the study creams will also be studied.

Conditions

Interventions

OTHER

dexpanthenol 5% cream

Apply at least two times a day on face, chest and upper arms during the 6 week treatment period

OTHER

Cetomacrogol cream

Apply at least two times a day on face, chest and upper arms during the 6 week treatment period

Sponsors & Collaborators

Principal Investigators

  • Christine Boers-Doets, MSc · Waterland Hospital, Purmerend, the Netherlands

  • Mario Lacouture, MD · Memorial Sloan-Kettering Cancer Center, USA

  • Johan Nortier, PhD · Leiden University Medical Centre, the Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

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 NCT01136005 on ClinicalTrials.gov