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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2013 by Rabin Medical Center.
Recruitment status was Recruiting

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

History of Changes

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:

MedlinePlus related topics: Rashes

U.S. FDA Resources

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 (Adult, Senior)
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

Publications:

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.

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.


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

ClinicalTrials.gov processed this record on September 23, 2016

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