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

Rash Due to Epidermal Growth Factor Receptor Inhibitors Clinical Trial

— EGFRI  

Official title:

A Phase II Randomized, Double Blind, Placebo Study to Evaluate the Efficacy of Vitamin K1 Cream Treatment Compared to Placebo for the Prevention of Papulo-pustular Rash in Metastatic Colorectal Patients Receiving First Line EGFRI Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763307
• Other study ID #: EGFRI-MER-1a-HMO-CTIL
• Status: Completed
• Phase: Phase 2
• Start date: January 2013
• Est. completion date: December 2018

Study information

• Verified date: August 2017
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2018
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• metastatic colon cancer patients

• male or female

• age> 18

• treated EGFRI

Exclusion Criteria:

• prior treatment with EGFRI

Related Conditions & MeSH terms

• Rash Due to Epidermal Growth Factor Receptor Inhibitors

Intervention

Drug:
• RECONVAL CREAM

• PLACEBO

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI	Reduction in numbers of papulo-pustular eruptions in the treatment fields compared to the placebo treated side. Changes in follicular eruptions, dryness/redness of skin estimated by the grading scale developed by the Multinational Association of Supportive Care in Cancer (MASCC) skin toxicity study group 4.0. Patients own experience of efficacy estimated by questionnaire.	12 weeks