Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT01136005
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01136005
Study Brief:
Protocol Section:
NCT01136005