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

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.

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

Official Title
-----------------
Double Blind Placebo Controlled Trial, for Evaluating Preventive Therapy With Either Oint Threolone Versus Synthomycine Versus Aqua Cream, for EGFR'I Induced Acneiform Rash

Conditions
-----------------
Acneiform Rash

Intervention / Treatment
-----------------
* Drug: Threolone ointment
* Drug: ointment Synthomycine
* Drug: Aqua cream


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ointment Threolone<br>Treatment with topical application of combined anti inflammatory and anti bacterial agent. | Drug: Threolone ointment<br>* ointment once daily for 1 month<br>Drug: ointment Synthomycine<br>* ointment once daily for 1 month<br>Drug: Aqua cream<br>* ointment once daily for 1 month<br>|
| Active Comparator: ointment Synthomycine<br>ointment once daily for 1 month | Drug: ointment Synthomycine<br>* ointment once daily for 1 month<br>Drug: Aqua cream<br>* ointment once daily for 1 month<br>|
| Placebo Comparator: Aqua cream<br> | Drug: Aqua cream<br>* ointment once daily for 1 month<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acneiform eruption, papulopustular, EGFR, cetuximab, erlotinib, gefitinib, panitumumab, eruption secondary to treatment with either cetuximab