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

Cancer research study

What is the primary objective of this study?

Objective: To assess the preemptive effect of Bepanthen® on decreasing the incidence of specific ≥ grade 2 dermatological side effects of interest in respect of compliance to EGFRI agents, HRQoL and the adherence during the 6-week skin treatment period. The adherence to the study creams will also be studied.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cancer

Skin Rash

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:creamapply at least two times a day on face, chest and upper arms during the 6 week treatment period

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

dexpanthenol 5% creamdexpanthenol 5% cream (Bepanthen)

cetomacrogol creama vehicle

Study Status

Completed

Start Date: September 2010

Completed Date: March 2017

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: grade 2 or more papulopustular eruption

Secondary Outcome: patient tolerability and satisfaction of study cream

Study sponsors, principal investigator, and references

Principal Investigator: Christine Boers-Doets, MSc

Lead Sponsor: Christine B Boers-Doets

Collaborator: Bayer

More information:https://clinicaltrials.gov/show/NCT01136005

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