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

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ClinicalTrials.gov Identifier: NCT01256437
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
iris amitay, Rabin Medical Center

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

Condition or disease Intervention/treatment Phase
Acneiform Rash Drug: Threolone ointment Drug: ointment Synthomycine Drug: Aqua cream Phase 2

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : January 2011
Actual Primary Completion Date : January 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: ointment Threolone
Treatment with topical application of combined anti inflammatory and anti bacterial agent.
 Drug: Threolone ointment
ointment once daily for 1 month
Drug: ointment Synthomycine
ointment once daily for 1 month
Drug: Aqua cream
ointment once daily for 1 month
Active Comparator: ointment Synthomycine
ointment once daily for 1 month
 Drug: ointment Synthomycine
ointment once daily for 1 month
Drug: Aqua cream
ointment once daily for 1 month
Placebo Comparator: Aqua cream Drug: Aqua cream
ointment once daily for 1 month


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256437


Locations
Israel
Davidoff Center, Rabin Medical Center, Beilinson
Petach Tikva,, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: iris amitay, Iris Amitay-Laish, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01256437     History of Changes
Other Study ID Numbers: 6046
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by iris amitay, Rabin Medical Center:
Acneiform eruption
papulopustular
EGFR
cetuximab
 erlotinib
gefitinib
panitumumab
eruption secondary to treatment with either cetuximab

Additional relevant MeSH terms:
Cetuximab
Antineoplastic Agents