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

Hadassah Medical Center

Status and phase: Completed; Phase 2

Conditions: Rash Due to Epidermal Growth Factor Receptor Inhibitors

Treatments: Drug: RECONVAL CREAM; Drug: PLACEBO

Study type: Interventional

Funder types: Other

Identifiers

NCT01763307

EGFRI-MER-1a-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• prior treatment with EGFRI

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

RECONVAL CREAM

Experimental group

Description:

half face treated with RECONVAL CREAM

Treatment:

Drug: RECONVAL CREAM

PLACEBO

Placebo Comparator group

Description:

half face treated with PLACEBO cream

Treatment:

Drug: PLACEBO