Use of Cicaplast balm B5, 2 to 3 applications per day, since the first day of iEGFR treatment initiation for 30 days to avoid or limit appearance of cutaneous toxicities related to iEGFR treatment.

Use of Dexeryl, 2 to 3 applications per day, since de first day of iEGFR treatment initiation for 30 days to avoid or limit appearence of cutaneous toxicities related to iEGFR treatment.

Head and Neck Squamous Cell Carcinoma

Colorectal Cancer

Non Small Cell Lung Cancer

Epidermal Growth Factor Receptor Inhibitor

The patients have to do 2 to 3 applications per day on the face, on lesions and in poultice in the evening in case of painful crack on the fingers

Cicaplast Balm B5

Dexeryl

Centre Léon Bérard

Satisfaction and Quality of Life Comparison Between Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGFR)

Comparative Monocentric Randomized Study Evaluating the Satisfaction and Quality of Life of Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGRF) in Carcinomas Squamous Cells of the Head and Neck, Colorectal Cancers or Lung Cancers

Overall patient satisfaction toward Cicaplast balm B5 or Dexeryl will be evaluated by a numerical scale from 0 to 10 in each arm

Quality of life of patient will be evaluated by using the Dermatology Life Quality Index questionnaire (DLQI) in each arm

Cutaneous toxicities will be evaluated in each arm by using Epidermal Repair Score (SCOREPI)

Cutaneous toxicities will be evaluated in each arm by using Common Terminology Criteria for Adverse Events (CTCAE) version 4

Modification/Interruption/Discontinuing iEGFR treatment rate in each arm because of cutaneous toxicity

Evaluation of DLQI (patient evaluation) and SCOREPI (investigator evaluation) scores correlation in each arm

Topical observance will be evaluated in each arm by data collection by each patient in a diary

Evaluation of the rate of patients needing to use dermocorticoids.

Centre Leon Berard

Arm A : Use of Cicaplast balm B5 since de first day of iEGFR initiation treatment for 30 days Arm B : Use of Dexeryl cream since de first day of iEGFR initiation treatment for 30 days

EGF cream was applied. Half of face was treated with emollient containing EGF.

Placebo cream without EGF was applied. The other half of face was treated with only emollient which was not containing EGF.

Drug-Related Side Effects and Adverse Reactions

Epidermal Growth Factor

A Split face study was done. Patients applied 1 finger tip unit of EGF cream on one side of face, twice a day for 4 weeks.
EGF cream(Repair Control EGF®) containing 10 ppm of rhEGF was prepared at D.N. Co., Ltd. (Seoul, South Korea)

Repair Control EGF®

A Split face study was done. Patients applied 1 finger tip unit of cream on the other side of face, twice a day for 4 weeks.
Placebo cream was prepared at at D.N. Co., Ltd. (Seoul, South Korea), consisted of same ingredient with EGF cream except rhEGF

Cream without rhEGF

St. Vincent's Hospital

Therapeutic Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors

The Therapeutic Effect of Topical EGF Cream for Dermatologic Adverse Events Related to EGFR Inhibitors

To evaluate the severity of acneiform eruption, the investigators take a photograph of full face. The number of inflammatory and noninflammatory lesions will be counted and accessed the severity based on the Korean Acne Grading System(KAGS).

Skin hydration is measured with Corneometer® (CM820/825; C-K Electronics, Cologne, Germany).
It shows the skin moisturizing condition in arbitrary units(AU) and the unit is from 0 to 220.

Sebum production is measured with Sebumeter® (SM815; C-K Electronics, Cologne, Germany).
It measured at forehead, cheek and chin, presented as ㎍/㎠.

Investigator's global assessment (IGA) Score : It will be assessed as a 5-point scale (-1 = worsen, to 3 = marked improvement).

Patient's global assessment (PGA) score will be assessed as a 5-point scale (-1 = worsen, to 3 =marked improvement).

Jung Min Bae

Clinical Assistant Professor

The Catholic University of Korea

EGF cream was applied. One half side of face and one hand were treated with emollient containing EGF.

Placebo cream without EGF was applied. The other half side of face and the other hand were treated with only emollient which was not containing EGF.

A Split face study was done. Patients applied 1 finger tip unit of EGF cream on one side of face, twice a day for 8 weeks. Also, to evaluate the preventive effect of paronychia, patients applied same cream on the finger tips of one side hand, twice a day for 8 weeks.
EGF cream(Repair Control EGF®) containing 10 ppm of rhEGF was prepared at D.N. Co., Ltd. (Seoul, South Korea)

A Split face study was done. Patients applied 1 finger tip unit of cream on the other side of face, twice a day for 8 weeks. Patients applied same cream on the finger tips of the other side hand, twice a day for 8 weeks.
Placebo cream was prepared at at D.N. Co., Ltd. (Seoul, South Korea), consisted of same ingredient with EGF cream except rhEGF

Preventive Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors

The Preventive Effect of Topical EGF Cream for Dermatologic Adverse Events Related to EGFR Inhibitors

To evaluate the development and severity of acneiform eruption, the investigators take a photograph of full face and hands on every visit.
If the acneiform eruption develop, the severity will be assessed based on the Korean Acne Grading System(KAGS).

The paronychia lesion will be assessed by CTCAE.

It measured with Corneometer® (CM820/825, C-K Electronics, Cologne, Germany). It shows in arbitrary units(AU) and the unit is from 0 to 220.

It measured with Sebumeter® (SM815; C-K Electronics, Cologne, Germany). It is measured at forehead, cheek and chin, presented as /㎍ ㎠. It shows in arbitrary units(AU) and the unit is from 0 to 220.

Investigator's global assessment (IGA) Score will be assessed with 5-point scale (-1 = worsen to 3 =marked improvement).

Patient's global assessment (PGA) score will be assessed with a 5-point scale (-1 = worsen, to 3 = marked improvement).

It will be assessed by patient-report.
- Any event developed during the trials can be reported.

paronychia/tyrosine

Satisfaction and Quality of Life Comparison Between Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGFR)

Therapeutic Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors

Preventive Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors

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