Skin and Connective Tissue Diseases

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Vitamin K

Vitamin K 1

Menadione

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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

Antineoplastic Agents

Anti-Infective Agents

Cetuximab

Anti-Bacterial Agents

Doxycycline

Antibiotics, Antitubercular

Mitogens

Panitumumab

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Active ingredient: Doxycycline Concentration: 4% Route: Topical Dosage schedule: Twice daily, morning and evening. Prophylactic treatment to prevent the rash associated with EGFRI treatment. patients will apply a thin layer of the drug twice daily for five weeks to one half of face

Active ingredient: None Route: Topical Dosage schedule: Twice daily, morning and evening. Patients will apply a thin layer of the placebo twice daily for five weeks to the opposite half of the face of which they received active treatment.

FDX104 - 4% or Placebo to be applied twice twice daily during 5 weeks

FDX104 (4% Doxycycline)

Ravit Geva, MD

Einat Shacham Shmueli, MD

Nirit Yarom, MD

Valerya Semenysty, MD

Ayala Hubert, MD

Alexander Gluzman, MD

Hadas Prag Nave, MD

The purpose of this study is to evaluate the safety, tolerability and efficacy of FDX104 Antibiotic Foam in the prevention of EGFRI skin toxicity in cancer patients receiving Cetuximab or Panitumumab.

This is a phase II multicenter, randomized, double blind, vehicle controlled clinical study to evaluate the safety, tolerability and efficacy of Doxycycline Foam 4% for the prevention of Epidermal Growth Factor Receptor Inhibition Skin Toxicity, to Subjects with Cancer Receiving Cetuximab or Panitumumab on a weekly or every 2 weeks basis.

The study consists of a screening visit, a treatment period where patients will be treated topically on the face twice daily for 5 weeks. A post-treatment follow up visit (4 weeks after end of treatment), will be performed only for subjects who have experienced unresolved possibly-related or related adverse events at the end of the treatment. Seven days after randomization and study drug initiation, subjects will start their EGFRI treatment.

Safety, Tolerability and Efficacy Study of Doxycycline Foam for the Prevention of EGFRI Skin Toxicity in Cancer Patients

A Safety, Tolerability and Efficacy Study of Doxycycline Topical Foam Administered Topically for Prevention of Epidermal Growth Factor Receptor Inhibition Skin Toxicity, to Subjects With Cancer Receiving Cetuximab or Panitumumab

Reduction in numbers of papulo-pustular eruptions in the treatment side compared to the placebo treated side and reduction in erythema or edema areas in the treatment side compared to the placebo treated side estimated by the MESTT grading scale developed by the Multinational Association of Supportive Care in Cancer (MASCC) and by visual scale of rash severity (Scope A. scale)

To demonstrate the safety and tolerability of FDX104 in terms of skin tolerability, adverse events, serious adverse events and vital signs in subjects with advanced cancer treated by EGFRI.

Vyne Therapeutics Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
Safety, Tolerability and Efficacy Study of Doxycycline Foam for the Prevention of EGFRI Skin Toxicity in Cancer Patients	NCT02239731	Rash Due to Epi...	FDX104 (4% Doxy...	18 Years -	Vyne Therapeutics Inc.

Spots Global Cancer Trial Database for rash due to epidermal growth factor receptor inhibitors