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EGFR Inhibitor

EGFR Inhibition for Skin Disorders

Phase 1 & 2
Waitlist Available
Led By Amy Paller
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be at least 18 years of age
Participant must have a clinically and genetically confirmed diagnosis of a keratinopathy
Must not have
Participant has infected lesions on the assessment area
Participant has had major surgery in the past 4 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial investigates the use of a drug called erlotinib, which inhibits a protein called EGFR that plays a role in skin cell growth and differentiation. The study aims to see if low

Who is the study for?
This trial is for individuals with certain skin conditions like Epidermolytic Hyperkeratosis and Palmoplantar Keratoderma. Participants should have symptoms such as thickened skin or malformed nails. The study is open to those who can tolerate oral medication and are not currently using other treatments that might interfere with the study.
What is being tested?
The trial tests Erlotinib, an EGFR inhibitor typically used in cancer treatment, at a low dose to see if it improves skin scaling and thickness in keratinopathies. It also aims to understand how Erlotinib affects cell growth, differentiation, pain relief, mobility, and immune system changes in these conditions.
What are the potential side effects?
Erlotinib may cause gastrointestinal issues like nausea or diarrhea and skin-related side effects such as rashes at higher doses; however, lower doses expected in this trial tend to have fewer adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My skin condition is confirmed as a keratinopathy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have infected sores in the area being examined.
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I had major surgery within the last 4 weeks.
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I have taken specific medications before or with erlotinib.
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I take medication that affects liver enzyme levels.
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I have been treated for cancer that spread beyond its original site within the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Grade 3 and 4 Adverse Events
Reduction in Investigator Global Assessment (IGA)

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531
29%
Nausea
19%
Leukopenia
14%
Anaemia
14%
Vomiting
14%
Neutropenia
14%
Alanine aminotransferase increased
14%
White blood cell count decreased
14%
Thrombocytopenia
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Musculoskeletal pain
5%
Dizziness
5%
Diarrhea
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Erlotinib Treatment ArmExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erlotinib
2011
Completed Phase 4
~2290

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,640 Previous Clinical Trials
957,528 Total Patients Enrolled
Yale UniversityOTHER
1,919 Previous Clinical Trials
3,040,311 Total Patients Enrolled
Amy PallerPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
1,696 Total Patients Enrolled
~29 spots leftby Jun 2029
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