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1% Topical Pimecrolimus Cream for the Treatment of the Rash Associated With ERBITUX

NCT01692626 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-03-15

Study results available
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Summary

When cancer patients are treated with the drug cetuximab they very often develop a rash. Usually it appears on their face and back and other parts of the body. The rash looks like acne and is treated with skin creams or antibiotics most of the time. The rash can become very painful and cause patients to stop using cetuximab to treat their cancer, even if cetuximab was helping fight their cancer.

Cetuximab is known to be a good drug to help treat cancer. This study will help us learn about the rash cetuximab causes so hopefully future patients can finish taking cetuximab for their cancer. In this study the investigators will use a cream called pimecrolimus (Elidel) to see if it will help prevent the rash or keep the rash from getting worse. The investigators also want to see how the rash affects patients and their quality of life.

Participants will be in this study for about four weeks if their rash does not get worse. They will need to apply the study cream and placebo two times daily and answer quality of life questionnaires during this study. Participants will also be seen by a dermatologist and have pictures taken of their rash.

Conditions

Interventions

DRUG

Pimecrolimus

Pimecrolimus 1% topical cream applied twice daily for four weeks on one side of the face.

DRUG

Placebo

Placebo cream applied twice daily for four weeks on opposite side of the face from the Pimecrolimus side.

Sponsors & Collaborators

  • West Virginia University

    lead OTHER

Principal Investigators

  • Mohammed Almubarak, MD · West Virginia University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01692626 on ClinicalTrials.gov