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

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	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Rashes

U.S. FDA Resources

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

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:	May 7, 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

ClinicalTrials.gov processed this record on September 21, 2017

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