A Study to Examine the Effect of Reconval K1 Cream to Prevent Skin Toxicity From EGFRI

NCT ID: NCT01763307

Last Updated: 2024-02-29

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-12-31

Brief Summary

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Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic colorectal cancer patients.

This study will prospectively accrue metastatic colorectal patients receiving EGFRI and treat with reconval cream half face versus placebo cream half face to study whether Vitamin k1 cream can prevent the typical skin eruption caused by EGFRI.

Detailed Description

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Conditions

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Rash Due to Epidermal Growth Factor Receptor Inhibitors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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RECONVAL CREAM

half face treated with RECONVAL CREAM

Group Type EXPERIMENTAL

RECONVAL CREAM

Intervention Type DRUG

PLACEBO

half face treated with PLACEBO cream

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DRUG

Interventions

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RECONVAL CREAM

Intervention Type DRUG

PLACEBO

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* metastatic colon cancer patients
* male or female
* age\> 18
* treated EGFRI

Exclusion Criteria

* prior treatment with EGFRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharon Merims, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medcial Organization

Other Identifiers

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EGFRI-MER-1a-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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