Bepanthen Versus Cetomacrogol in Epidermal Growth Factor Receptor Inhibitors (EGFRI)

Launched by IMPAQTT FOUNDATION · Jun 2, 2010

Keywords

ClinConnect Summary

Rationale:

Dermatological side effects, such as papulopustular eruption, xerosis, pruritus, periungual inflammation, mucosal-, and hair abnormalities, and edema occur in up to 90% of patients during treatment with epidermal growth factor receptor inhibitors (EGFRI). Patients are hindered in their daily activities and cannot maintain privacy about their illness because of the prominent side effects. The aesthetic discomfort, which is frequently associated with itching or painful skin or nails can lead to a decreased health related quality of life (HRQoL) and to dose reduction or discontinua...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Male and female subjects
• • ≥18 years of age.
• • Patients must have signed an approved informed consent form prior to registration on study.
• • Histological proof of cancer.
• • A planned course of EGFRI treatment for any type of cancer. Patients must be entered on study ≤ 7 days before EGFRI treatment begins.
• • Have an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2.
• • Ability to complete questionnaire(s) by themselves or with assistance.
• • Patients need to be free of infection and not using any topical treatments on the skin.
• Exclusion Criteria:
• • Use of other concurrent topical creams or lotions at baseline.
• • Concomitant use of medications that may affect trial results (e.a. concurrent use of topical antibiotics, topical steroids, and other topical treatments on face and chest within 14 days of Day 0 (baseline); treatment with any systemic antibiotics within 7 days prior to Day 0.
• • Active dermatological conditions other than papulopustular eruption that may affect trial results. A skin examination reveals the presence of another skin disease in face or chest that may obscure rash to EGFRI and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the skin that, in the study physician's opinion, would confound the evaluation of the papulopustular eruption.
• • Known allergy or hypersensitivity to ingredients in Bepanthen® or Cetomacrogol.
• • Known sensitivity, papulopustular eruption or other abnormal skin reaction to topical or systemic medications or cleansing products at baseline.
• • Prior treatment with targeted therapy of any kind.
• • Current use of agents that are known to be strong inducers or inhibitors of CYP3A4 that can not be stopped