Evaluating Preventive Therapy With Oint Threolone, Synthomycine or Aqua Cream, for EGFR'I Induced Acneiform Rash
EGFR'I
Double Blind Placebo Controlled Trial, for Evaluating Preventive Therapy With Either Oint Threolone Versus Synthomycine Versus Aqua Cream, for EGFR'I Induced Acneiform Rash
1 other identifier
interventional
90
1 country
1
Brief Summary
The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2010
CompletedFirst Posted
Study publicly available on registry
December 8, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMay 9, 2017
May 1, 2017
6 years
December 7, 2010
May 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms.
3 years
Secondary Outcomes (1)
Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms
3 years
Study Arms (3)
ointment Threolone
EXPERIMENTALTreatment with topical application of combined anti inflammatory and anti bacterial agent.
ointment Synthomycine
ACTIVE COMPARATORointment once daily for 1 month
Aqua cream
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients who are planed to initiate treatment with either cetuximab , erlotinib, gefitinib or panitumumab.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Davidoff Center, Rabin Medical Center, Beilinson
Petah Tikva, Israel, 49100, Israel
Related Publications (2)
Lee JE, Lee SJ, Lee HJ, Lee JH, Lee KH. Severe acneiform eruption induced by cetuximab (Erbitux). Yonsei Med J. 2008 Oct 31;49(5):851-2. doi: 10.3349/ymj.2008.49.5.851.
PMID: 18972607BACKGROUNDLacouture ME, Mitchell EP, Piperdi B, Pillai MV, Shearer H, Iannotti N, Xu F, Yassine M. Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-Emptive Skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. J Clin Oncol. 2010 Mar 10;28(8):1351-7. doi: 10.1200/JCO.2008.21.7828. Epub 2010 Feb 8.
PMID: 20142600BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Iris Amitay-Laish, MD
Study Record Dates
First Submitted
December 7, 2010
First Posted
December 8, 2010
Study Start
January 1, 2011
Primary Completion
January 1, 2017
Study Completion
March 1, 2017
Last Updated
May 9, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share