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Phase III Randomized Double-Blind Trial of Bepanthen® Cream Versus Cetomacrogol Cream in the Prevention of Papulopustular Eruption in Patients Receiving Epidermal Growth Factor Receptor Inhibitors (EGFRI): BeCet

Phase 3
18 Years
Open (Enrolling)
Cancer, Skin Rash

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Trial Information

Phase III Randomized Double-Blind Trial of Bepanthen® Cream Versus Cetomacrogol Cream in the Prevention of Papulopustular Eruption in Patients Receiving Epidermal Growth Factor Receptor Inhibitors (EGFRI): BeCet


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 discontinuation of anticancer treatment.

Patients with dermatological side effects have also an increased risk for cutaneous
infections (at least 38%) which can complicate dermatological side effects.

At present, evidence of the effectiveness of the management options for dermatological side
effects is lacking, and the effect of the dermatological side effects on HRQoL and adherence
remains poorly understood.

Dexpanthenol cream (Bepanthen®, Bayer) has been used extensively to ameliorate acute
radiation induced skin toxicity, diaper dermatitis, irritant hand dermatitis, graft-donor
site wound healing and burn patients. The hypothesis is that its skin healing possibilities
decreases this kind of side effects.

Study design:

Multicenter, two-arm randomized, double blind, prospective parallel group design, phase III

Study population:

Each patient starting for the first time with EGFRI anticancer therapy which can cause
papulopustular eruption (cetuximab, panitumumab, erlotinib, gefitinib, lapatinib, or other),
will be included.


80 patients will receive for the first 6 weeks of treatment Bepanthen cream, 80 patients
Cetomacrogol cream to apply twice daily. Using FACT-EGFRI, a dermatology-specific
questionnaire, this study examines the effect of these side effects on three domains of
HRQoL - symptoms, emotions, and functioning. Severity of dermatological side effects will be
assessed using the NCI-CTCAE v4.0. Correlation of dermatology HRQoL scores with NCI-CTCAE
grade, sex, age, type of EGFRI, and cancer type will be conducted.

Inclusion Criteria:

- Male and female subjects

- ≥18 years of age.

- Patients must have signed an approved informed consent form prior to registration on

- 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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

grade 2 or more papulopustular eruption

Outcome Description:

The incidence of grade ≥ 2 papulopustular eruption during the 6 week skin treatment within Bepanthen and Cetomacrogol, as measured by the CTCAE v4.0 and DERETT-H, an dermatologic specific healthcare provider questionnaire for Dermatological Reactions Targeted Therapy.

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Christine Boers-Doets, MSc

Investigator Role:

Study Chair

Investigator Affiliation:

Waterland Hospital, Purmerend, the Netherlands


Netherlands: Medical Ethics Review Committee (METC)

Study ID:




Start Date:

September 2010

Completion Date:

June 2014

Related Keywords:

  • Cancer
  • Skin Rash
  • receptor, epidermal growth factor
  • skin toxicity
  • quality of life
  • adherence
  • Exanthema