Evaluation of a Cosmetic Product to Preserve Skin Conditions When Using Anti-EGFR Cancer Therapies

Study Overview
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Brief Summary
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It is important for patients treated with anti-EGFR therapies to get access to cosmetic options to preserve their skin condition during treatment. Anti-EGFR therapies are known to fragilize epidermis and to provoke rashes; which often lead to treatment discontinuation. The aim of this study is to demonstrate that the Onco-Rash cream is able to preserve skin condition without side effects. Decreasing skin toxicity is expected to improve patients' life and facilitate treatment follow-up.

Official Title
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Evaluation of a Cosmetic Product (Onco-Rash) to Preserve Skin Conditions When Using Anti-EGFR Cancer Therapies Which Are Known to Fragilize Epidermis

Conditions
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Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Head and Neck Neoplasms

Intervention / Treatment
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* Drug: Application of Onco-Rash cream
* Drug: Application of Onco-Neutre cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient > 18 years old Patient naive from anti-EGFR treatment (gefitinib, erlotinib, afatinib, cetuximab panitumumab, osimertinib, alectinib et crizotinib, etc). NSCLC (non-small cell lung cancer) patients eligible to anti-EGFR as first line treatment (gefitinib, erlotinib,afatinib, etc) Colorectal cancer patients eligible to anti-EGFR as first line treatment (cetuximab, panitumumab,….) Head and Neck/ENT (Ear, Nose Troat) cancer patients eligible to anti-EGFR as first line treatment (cetuximab,…) Signed informed consent Social security affiliation Exclusion Criteria: Pregnant or Breastfeeding patient Patient in age to procreate without an efficient contraceptive method Patient with previous experience of allergic or irritative contact dermatitis to components of the studied product Patient with dermatologic conditions that cannot permit the study of skin toxicity of anti-EGFR Patients under radiotherapy 8 days prior the inclusion date Patient under immunotherapy 8 days prior the inclusion date Patient with local or systemic antibiotic treatment for acne 8 days prior the inclusion date Patient with antihistamines treatment 8 days prior the inclusion date Patients taking NSAIDs or corticoids as chronic medication or that took NSAIDs or corticoids 5 days prior the inclusion date Participation to another interventional study Patient with an altered ECOG (Eastern Cooperative Oncology Group) state ( >2) Patient deprived of liberty or subjected to guardianship Impossibility to track and follow patient for geographical, social or psychiatric reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Onco-Rash arm<br>In this arm label, patients will apply the Onco-Rash cream on selected zones (face, neck, thorax,…) twice a day, during 6 weeks. This arm will be compared to the Onco-Neutral arm, in which the Onco-Neutral cream will be applied on selected zones (face, neck, thorax,…) twice a day, during 6 weeks. | Drug: Application of Onco-Rash cream<br>* The cream Onco-Rash will be administered topically. The patient will be asked to apply the cream twice a day in the morning and evening for 6 weeks to clean, dry skin on selected target areas of the body, namely: the face, the front of the neck, the front of the chest, the back of the neck and the back of the chest. The product penetrates by gentle massage.<br>|
| Placebo Comparator: Onco-Neutre arm<br>In this arm label, patients will apply the Onco-Neutre cream on selected zones (face, neck, thorax,…) twice a day, during 6 weeks. Onco-Neutral cream will be used as an experimental comparator to Onco-Rash cream. This arm will be compared to the Onco-Neutral arm, in which the Onco-Neutral cream will be applied on selected zones (face, neck, thorax,…) twice a day, during 6 weeks. | Drug: Application of Onco-Neutre cream<br>* The cream Onco-Neutre will be administered topically. The patient will be asked to apply the cream twice a day in the morning and evening for 6 weeks to clean, dry skin on selected target areas of the body, namely: the face, the front of the neck, the front of the chest, the back of the neck and the back of the chest. The product penetrates by gentle massage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the percentage of Onco-Rash failure by counting the number of patients with a rash grade ≥ 2 (NCI-CTCAE scale). | Measurement of Onco-Rash percentage of failure by counting the number of patients for whom a skin rash with a grade ≥ 2 (NCI-CTCAE scale) will occur between 0-6 weeks after the start of the anti-EGFR treatment. The introduction of an anti-inflammatory, a calming or an antibiotic treatment for acne will also be considered as failure. | 6 weeks after the start of the anti-EGFR treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing of apparition of grade 1, 2 or ≥ 2 skin eruption: number of days between the start of the anti-EGFR treatment and the apparition of a skin eruption. | Comparison of timing of apparition of grade 1, 2 or ≥ 2 skin eruption between the Onco-Rash arm and the Onco-Neutral arm. | 6 weeks after the start of the anti-EGFR treatment. | 
| Percentage of patients with a grade 1, 2 or ≥ 2 skin eruption | Number of patients for whom a grade 1, 2 or ≥ 2 skin eruption have been reported | 6 weeks after the start of the anti-EGFR treatment. | 
| Percentage of patients for whom treatment for acne (anti-inflammatory or antibiotic) has been introduced | Number of patients for whom treatment for acne (anti-inflammatory or antibiotic) has been prescribed | 6 weeks after the start of the anti-EGFR treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cosmetic Product, Acne, Skin Rash, anti-EGFR therapy, Cancer patients