1% Topical Pimecrolimus Cream for the Treatment of the Rash Associated With ERBITUX
Rash
About this trial
This is an interventional supportive care trial for Rash focused on measuring Cetuximab rash, Erbitux rash, Rash, Pimecrolimus, 1% Topical pimecrolimus cream
Eligibility Criteria
Inclusion Criteria:
- Patient is starting treatment with cetuximab at the WVU Cancer Center
- Patient has advanced (unresectable or metastatic) malignancy
- Patient is expected to remain on cetuximab treatment for at least 2 weeks after enrollment on study.
- Patients should be 18 years or older
- Patients should not have a known contraindication to topical pimecrolimus therapy
- Patients should have given written informed consent
- Sexually active men and women of child bearing potential agree to use an effective method of contraception during study participation and for three months afterwards.
- Negative pregnancy test for woman of child bearing potential
Exclusion Criteria:
- Known allergy to topical pimecrolimus.
- Patients with active or recent (within one month) infection in face
- Psoriasis, eczema or others skin conditions not related to cetuximab involving face
- Pregnant or nursing women
Sites / Locations
- West Virginia University Hospitals Mary Babb Randolph Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Pimecrolimus on Left vs. Placebo on Right
Pimecrolimus on Right vs. Placebo on Left
Patients will apply a thin layer of the Pimecrolimus cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.
Patients will apply a thin layer of the Pimecrolimus cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.