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Doxycycline

Vitamin K

Vitamin K 1

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Reconval K1 Cream

Reconval Cream

Ralf Hofheinz, Prof.

The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients receiving first line cetuximab treatment.

Randomized Phase II Trial assessing the prevention of acne like Skin rash

Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream

A Double Blind Placebo Controlled Randomized Phase II Study Evaluating the Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream in First Line mCRC Patients Treated With Erbitux and FOLFIRI.

Universitätsmedizin Mannheim

Head TTZ University Hospital Mannheim

Skin and Connective Tissue Diseases

Exanthema

Herbal and Botanical

Cola

RECONVAL CREAM

PLACEBO

Sharon Merims, MD

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.

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

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.

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.

Hadassah Medical Organization

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream	NCT01345526	Metastatic Colo...	Reconval K1 Cre... Reconval Cream	18 Years -	Universitätsmedizin Mannheim
A Study to Examine the Effect of Reconval K1 Cream to Prevent Skin Toxicity From EGFRI	NCT01763307	Rash Due to Epi...	RECONVAL CREAM PLACEBO	18 Years -	Hadassah Medical Organization
Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream	NCT01345526	Metastatic Colo...	Reconval K1 Cre... Reconval Cream	18 Years -	Universitätsmedizin Mannheim

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