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

This study is currently recruiting participants.
Verified October 2013 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
iris amitay, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01256437
First received: December 7, 2010
Last updated: October 27, 2013
Last verified: October 2013
  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 lotion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Lotion, for EGFR'I Induced Acneiform Rash

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (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 lotion
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 lotion
ointment once daily for 1 month
Placebo Comparator: Aqua cream lotion Drug: Aqua cream lotion
ointment once daily for 1 month

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256437

Contacts
Contact: Iris Amitay-Laish, MD 972-3-937-7160/3 amitay2@zahav.net.il
Contact: Salomon Stemmer, MD 972-3-937-7160/3 stemmer@post.tau.ac.il

Locations
Israel
Davidoff Center, Rabin Medical Center, Beilinson Recruiting
Petach Tikva,, Israel, 49100
Contact: Iris Amitay-Laish, MD    972-3-937-7160/3    amitay2@zahav.net.il   
Principal Investigator: Iris Amitay-Laish, MD         
Principal Investigator: SALOMON STEMMER, MD         
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: October 27, 2013
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Exanthema
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014