Evaluating Preventive Therapy With Oint Threolone, Synthomycine or Aqua Cream, for EGFR'I Induced Acneiform Rash

Rabin Medical Center90 enrolled

Overview

The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Acneiform Rash

Interventions

Threolone ointmentDRUG

ointment once daily for 1 month

ointment SynthomycineDRUG

ointment once daily for 1 month

Aqua creamDRUG

ointment once daily for 1 month

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are planed to initiate treatment with either cetuximab , erlotinib, gefitinib or panitumumab. Exclusion Criteria: * Patients who received any facial topical treatment / systemic antibiotics or any anti-inflammatory drug during the 2 weeks prior to study initiation. * Known hypersensitivity to ointment Synthomycine or to Threolone. * Patients presented with cutaneous rash during the 2 weeks prior to study initiation

Locations (1)

Davidoff Center, Rabin Medical Center, Beilinson

Petah Tikva, Israel, Israel

Outcomes

Primary Outcomes

Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms.

Time frame: 3 years

Secondary Outcomes

Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms

Time frame: 3 years

Data from ClinicalTrials.gov

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