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OpenTrials
Completed

NCT Number: NCT01256437

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

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

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Key information

Conditions

Acneiform Rash Acneiform Eruptions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Davidoff Center, Rabin Medical Center, Beilinson

Petah Tikva, Israel, 49100

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Threolone ointment

Drug

ointment once daily for 1 month

ointment Synthomycine

Drug

ointment once daily for 1 month

Aqua cream

Drug

ointment once daily for 1 month

Primary outcomes

  1. 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 outcomes

  1. Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study 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

Acronym: EGFR'I

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2010
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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