Trial Outcomes & Findings for 1% Topical Pimecrolimus Cream for the Treatment of the Rash Associated With ERBITUX (NCT NCT01692626)
NCT ID: NCT01692626
Last Updated: 2017-03-15
Results Overview
To determine if 1% pimecrolimus prevents the rash associated with treatment with cetuximab, as assessed by lesion counts on clinical photographs after two weeks of treatment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
2 weeks
Results posted on
2017-03-15
Participant Flow
Participant milestones
| Measure |
Right Side Investigational Cream / Placebo on Left Side
Patients will apply a thin layer of the investigational 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.
Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks.
|
Left Side Investigational Cream/Placebo Cream on Right Side
Patients will apply a thin layer of the investigational 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.
Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Right Side Investigational Cream / Placebo on Left Side
Patients will apply a thin layer of the investigational 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.
Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks.
|
Left Side Investigational Cream/Placebo Cream on Right Side
Patients will apply a thin layer of the investigational 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.
Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
1% Topical Pimecrolimus Cream for the Treatment of the Rash Associated With ERBITUX
Baseline characteristics by cohort
| Measure |
Investigational Cream/Placebo Cream
n=13 Participants
Patients will apply a thin layer of the investigational 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.
Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks.
|
|---|---|
|
Age, Customized
<18 years
|
0 participants
n=99 Participants
|
|
Age, Customized
>= 18 - 69 years
|
8 participants
n=99 Participants
|
|
Age, Customized
>= 70 years
|
5 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 weeksTo determine if 1% pimecrolimus prevents the rash associated with treatment with cetuximab, as assessed by lesion counts on clinical photographs after two weeks of treatment.
Outcome measures
| Measure |
Left sidePimecrolimus Cream
n=2 Participants
The left side of the face that the Pimecrolimus Cream was applied.
|
The Right Side the Pimecrolimus Cream
n=1 Participants
The right side of the face that the pimecrolimus cream was applied.
|
|---|---|---|
|
Percentage of Participants That do Not Experience Rash From Cetuximab Treatment on the Pimecrolimus Side of the Face.
|
2 Participants
|
1 Participants
|
Adverse Events
Investigational Cream/Placebo Cream
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Investigational Cream/Placebo Cream
n=13 participants at risk
Patients will apply a thin layer of the investigational 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.
Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
7.7%
1/13 • Number of events 1 • Adverse Events were collected for 1 year 9 months. The time from when the first participant went on the study until the last time the all the participants were off of the study.
No difference in the definition. Adverse events that occur after the subject has signed the informed consent must be documented in the study database/case report forms, subject's medical records, and as required per additional institutional standards. Source documentation must be available to support all reported adverse events. Serious Adverse Events (SAE) requiring expedited reporting within 24 hours will also be reported to the Medical Director for Clinical Trials.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
15.4%
2/13 • Number of events 2 • Adverse Events were collected for 1 year 9 months. The time from when the first participant went on the study until the last time the all the participants were off of the study.
No difference in the definition. Adverse events that occur after the subject has signed the informed consent must be documented in the study database/case report forms, subject's medical records, and as required per additional institutional standards. Source documentation must be available to support all reported adverse events. Serious Adverse Events (SAE) requiring expedited reporting within 24 hours will also be reported to the Medical Director for Clinical Trials.
|
Additional Information
Mohammed Almubarak, MD, Assistant Professor
West Virginia University
Phone: 304-293-4229
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place