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

NCT ID: NCT01256437

Last Updated: 2017-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2017-03-31

Brief Summary

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

Detailed Description

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

Conditions

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Acneiform Rash

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ointment Threolone

Treatment with topical application of combined anti inflammatory and anti bacterial agent.

Group Type EXPERIMENTAL

Threolone ointment

Intervention Type DRUG

ointment once daily for 1 month

ointment Synthomycine

Intervention Type DRUG

ointment once daily for 1 month

Aqua cream

Intervention Type DRUG

ointment once daily for 1 month

ointment Synthomycine

ointment once daily for 1 month

Group Type ACTIVE_COMPARATOR

ointment Synthomycine

Intervention Type DRUG

ointment once daily for 1 month

Aqua cream

Intervention Type DRUG

ointment once daily for 1 month

Aqua cream

Group Type PLACEBO_COMPARATOR

Aqua cream

Intervention Type DRUG

ointment once daily for 1 month

Interventions

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Threolone ointment

ointment once daily for 1 month

Intervention Type DRUG

ointment Synthomycine

ointment once daily for 1 month

Intervention Type DRUG

Aqua cream

ointment once daily for 1 month

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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iris amitay

Iris Amitay-Laish, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Davidoff Center, Rabin Medical Center, Beilinson

Petah Tikva, Israel, Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 18972607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20142600 (View on PubMed)

Other Identifiers

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6046

Identifier Type: -

Identifier Source: org_study_id

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