Clinical trial · Interventional
Bepanthen Versus Cetomacrogol in Epidermal Growth Factor Receptor Inhibitors (EGFRI)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Skin Rash | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetomacrogol cream | Other | — | UNRESOLVED |
| dexpanthenol 5% cream | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- dexpanthenol 5% cream
- description
- dexpanthenol 5% cream
- interventionNames
- Other: dexpanthenol 5% cream
- type
- ACTIVE_COMPARATOR
- label
- cetomacrogol cream
- description
- a vehicle
- interventionNames
- Other: Cetomacrogol cream
Primary outcomes (2)
- measure
- grade 2 or more papulopustular eruption
- timeFrame
- 6 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDDevireddy T, Lim C, Patel J, Tan IJ, Cohen BA. Cutaneous Adverse Effects of EGFR Therapy in Breast Cancer Treatment. Clin Transl Sci. 2025 Dec;18(12):e70432. doi: 10.1111/cts.70432. PMID 41351479
- DERIVEDClabbers JMK, Boers-Doets CB, Gelderblom H, Stijnen T, Lacouture ME, van der Hoeven KJM, Kaptein AA. Xerosis and pruritus as major EGFRI-associated adverse events. Support Care Cancer. 2016 Feb;24(2):513-521. doi: 10.1007/s00520-015-2781-y. Epub 2015 Jun 27. PMID 26111953
- DERIVEDBoers-Doets CB, Gelderblom H, Lacouture ME, Epstein JB, Nortier JW, Kaptein AA. Experiences with the FACT-EGFRI-18 instrument in EGFRI-associated mucocutaneous adverse events. Support Care Cancer. 2013 Jul;21(7):1919-26. doi: 10.1007/s00520-013-1752-4. Epub 2013 Feb 17. PMID 23417565