Double Blind Placebo Controlled Trial, for Evaluating Preventive Therapy With Either Oint Threolone Versus Synthomycine Versus Aqua Cream, for EGFR'I Induced Acneiform Rash
Overview
- Phase
- Phase 2
- Intervention
- Threolone ointment
- Conditions
- Acneiform Rash
- Sponsor
- Rabin Medical Center
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms.
- Status
- Completed
- Last Updated
- 8 years ago
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.
Investigators
iris amitay
Iris Amitay-Laish, MD
Rabin Medical Center
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
Arms & Interventions
ointment Threolone
Treatment with topical application of combined anti inflammatory and anti bacterial agent.
Intervention: Threolone ointment
ointment Threolone
Treatment with topical application of combined anti inflammatory and anti bacterial agent.
Intervention: ointment Synthomycine
ointment Threolone
Treatment with topical application of combined anti inflammatory and anti bacterial agent.
Intervention: Aqua cream
ointment Synthomycine
ointment once daily for 1 month
Intervention: ointment Synthomycine
ointment Synthomycine
ointment once daily for 1 month
Intervention: Aqua cream
Aqua cream
Intervention: Aqua cream
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(3 years)