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

Phase 2

Completed

• Conditions: Acneiform Rash
• Interventions: Drug: Threolone ointment; Drug: ointment Synthomycine; Drug: Aqua cream

• Registration Number: NCT01256437
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-07
• Study First Posted: 2010-12-08
• Study Start: 2011-01
• Primary Completion: 2017-01
• Study Completion: 2017-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-07
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ointment Threolone	ointment Synthomycine	Treatment with topical application of combined anti inflammatory and anti bacterial agent.
ointment Synthomycine	ointment Synthomycine	ointment once daily for 1 month
ointment Threolone	Threolone ointment	Treatment with topical application of combined anti inflammatory and anti bacterial agent.
ointment Threolone	Aqua cream	Treatment with topical application of combined anti inflammatory and anti bacterial agent.
ointment Synthomycine	Aqua cream	ointment once daily for 1 month
Aqua cream	Aqua cream	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms	3 years

Trial Locations

Locations (1)

Davidoff Center, Rabin Medical Center, Beilinson; 🇮🇱 Petach Tikva,, Israel