Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT04483856
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2020-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis.
Sponsor:
Relife Italia S.r.l.
Organization:
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:
2025-04
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:
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?: