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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
iris amitay, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01256437
First received: December 7, 2010
Last updated: May 7, 2017
Last verified: May 2017
  Purpose
The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.

Condition Intervention Phase
Acneiform Rash Drug: Threolone ointment Drug: ointment Synthomycine Drug: Aqua cream Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by iris amitay, Rabin Medical Center:

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

Enrollment: 90
Study Start Date: January 2011
Study Completion Date: March 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256437

Locations
Israel
Davidoff Center, Rabin Medical Center, Beilinson
Petach Tikva,, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
  More Information

Additional 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
Study First Received: December 7, 2010
Last Updated: May 7, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on June 22, 2017