Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 1:39 PM
Study NCT ID:
NCT04929834
Status:
UNKNOWN
Last Update Posted:
2023-02-28
First Post:
2021-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities
Sponsor:
Jessa Hospital
Organization:
Study Overview
Official Title:
Evaluation of Novel Skin Care Products for the Management of Immunotherapy- Related Dermatologic Toxicities
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ImmunoSkin
Brief 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.
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.
Detailed Description:
Primary objective Evaluate the efficacy of two novel skin care products for the management of immunotherapy-related cutaneous adverse events
Secondary objective 1 Evaluate patient-relevant treatment benefit of two novel skin care products for immunotherapy-related cutaneous toxicities
Secondary objective 2 Evaluate the influence of two novel skin care products for immunotherapy-related cutaneous toxicities on the patient's quality of life
Secondary objective 3 Evaluate the safety of two novel skin care products for immunotherapy-related cutaneous toxicities
Secondary objective 1 Evaluate patient-relevant treatment benefit of two novel skin care products for immunotherapy-related cutaneous toxicities
Secondary objective 2 Evaluate the influence of two novel skin care products for immunotherapy-related cutaneous toxicities on the patient's quality of life
Secondary objective 3 Evaluate the safety of two novel skin care products for immunotherapy-related cutaneous toxicities
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: