Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04483856
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2020-07-13
Brief Title:
Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis
Sponsor:
Relife Italia Srl
Organization:
Relife Italia Srl
Study Overview
Official Title:
Efficacy and Tolerability Evaluation of a Topical Medical Device Based on SHBF in Management of Radiodermatitis An Observer-masked Controlled Study
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
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:
DRESDA
Brief Summary:
This is a post marketing interventional randomized single-center prospective controlled study for the evaluation of the clinical performance and tolerability of a cream-based medical device DermoRelizemaTM cream in the management care of radiodermatitis in women with breast cancer Assessments and evaluations will be performed by a physician in a blind fashion
The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity using the grading system of the Radiation Therapy Oncology Group European Organization for Research and Treatment of Cancer RTOG EORTC at the conclusion of the treatment period
The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity using the grading system of the Radiation Therapy Oncology Group European Organization for Research and Treatment of Cancer RTOG EORTC at the conclusion of the treatment period
Detailed Description:
This is a post marketing interventional randomized single-center prospective controlled study for the evaluation of the clinical performance and tolerability of a cream-based medical device DermoRelizemaTM cream in the management care of radiodermatitis in women with breast cancer Assessments and evaluations will be performed by a physician in a blind fashion
The aim of this clinical study is to collect controlled evidences of the effectiveness and tolerability of DermoRelizemaTM cream in the management of RISRs in patients with breast cancer who will start the treatment with the product about one week before the start of RT
The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity using the grading system of the Radiation Therapy Oncology Group European Organization for Research and Treatment of Cancer RTOG EORTC at the conclusion of the treatment period
The aim of this clinical study is to collect controlled evidences of the effectiveness and tolerability of DermoRelizemaTM cream in the management of RISRs in patients with breast cancer who will start the treatment with the product about one week before the start of RT
The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity using the grading system of the Radiation Therapy Oncology Group European Organization for Research and Treatment of Cancer RTOG EORTC at the conclusion of the treatment period
Study Oversight
Has Oversight DMC:
None
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?:
None