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

This study is currently recruiting participants. (see Contacts and Locations)
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
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

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 July 20, 2014