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Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities

NCT04929834 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-02-28

No results posted yet for this study

Summary

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

  • Skin Toxicity
  • Immunotoxicity

Interventions

OTHER

Hydrating emollient + body lotion for immunotherapy-related side effects

Hydrating, hypo-allergenic, and anti- itching emollient and body lotion for immunotherapy-related skin reactions

Sponsors & Collaborators

  • Hasselt University

    collaborator OTHER

  • Jessa Hospital

    lead OTHER

Principal Investigators

  • Jeroen Mebis, MD, PhD · Jessa Ziekenhuis VZW

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04929834 on ClinicalTrials.gov