Back to resultsEvaluating Preventive Therapy With Oint Threolone, Synthomycine or Aqua Cream, for EGFR'I Induced Acneiform Rash (EGFR'I)
Primary Purpose
Acneiform Rash
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Threolone ointment
ointment Synthomycine
Aqua cream
Sponsored by
About this trial
This is an interventional prevention trial for Acneiform Rash focused on measuring Acneiform eruption, papulopustular, EGFR, cetuximab, erlotinib, gefitinib, panitumumab, eruption secondary to treatment with either cetuximab
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
Sites / Locations
- Davidoff Center, Rabin Medical Center, Beilinson
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
ointment Threolone
ointment Synthomycine
Aqua cream
Arm Description
Treatment with topical application of combined anti inflammatory and anti bacterial agent.
ointment once daily for 1 month
Outcomes
Primary Outcome Measures
Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms.
Secondary Outcome Measures
Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01256437
Brief Title
Evaluating Preventive Therapy With Oint Threolone, Synthomycine or Aqua Cream, for EGFR'I Induced Acneiform Rash
Acronym
EGFR'I
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acneiform Rash
Keywords
Acneiform eruption, papulopustular, EGFR, cetuximab, erlotinib, gefitinib, panitumumab, eruption secondary to treatment with either cetuximab
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ointment Threolone
Arm Type
Experimental
Arm Description
Treatment with topical application of combined anti inflammatory and anti bacterial agent.
Arm Title
ointment Synthomycine
Arm Type
Active Comparator
Arm Description
ointment once daily for 1 month
Arm Title
Aqua cream
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Threolone ointment
Intervention Description
ointment once daily for 1 month
Intervention Type
Drug
Intervention Name(s)
ointment Synthomycine
Intervention Description
ointment once daily for 1 month
Intervention Type
Drug
Intervention Name(s)
Aqua cream
Intervention Description
ointment once daily for 1 month
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Davidoff Center, Rabin Medical Center, Beilinson
City
Petach Tikva,
ZIP/Postal Code
49100
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
18972607
Citation
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.
Results Reference
background
PubMed Identifier
20142600
Citation
Lacouture 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.
Results Reference
background
Learn more about this trial
Evaluating Preventive Therapy With Oint Threolone, Synthomycine or Aqua Cream, for EGFR'I Induced Acneiform Rash
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