Clinical trial · Interventional
Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities
Evaluation of Novel Skin Care Products for the Management of Immunotherapy- Related Dermatologic Toxicities
- 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)
Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. The number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new immunomodulatory agents. The immunotherapy-related skin toxicities can significantly impede the patient's emotional, physical, social, and financial well-being resulting in a poor QoL. In rare cases of severe cutaneous reactions, treatment modifications are needed, resulting in a diminished overall survival. Important organizations in the field of oncology and supportive care, such as the MASCC, the ASCO, and the ESMO, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. Still, for some interventions, the evidence of recommendation is moderate to insufficient. Therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. Based on the previously mentioned supportive care guidelines for the ImmunoSkin project, two novel skin care products to tackle the cutaneous adverse events of immunotherapy have been developed. The ImmunoSkin project general aim is to evaluate the efficacy of two novel skincare products to manage immunotherapy-related cutaneous toxicities.
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 |
|---|---|---|---|
| Immunotoxicity | — | UNRESOLVED | — |
| Skin Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrating emollient + body lotion for immunotherapy-related side effects | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- All patients will receive the experimental emollients during 3 weeks.
- interventionNames
- Other: Hydrating emollient + body lotion for immunotherapy-related side effects
Primary outcomes (4)
- measure
- Skin reaction evaluation
- timeFrame
- Baseline
- description
- The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) will be used to evaluate the skin reactions in the cancer patients
- measure
- Skin reaction evaluation
- timeFrame
- Week 3 of immunotherapy (end of study)
- description
- The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) will be used to evaluate the skin reactions in the cancer patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with cancer of any type * Undergoing immunotherapy, check point inhibitors, at the Jessa Hospital (Hasselt, BE) * Age ≥ 18 years * Able to comply to the study protocol * Able to sign written informed consent Exclusion Criteria: * Pre-existing skin rash, ulceration, skin infections or open wounds * Severe psychological disorder or dementia * Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
References
Publications (0)
Data not yet available