Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis.

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Efficacy and Tolerability Evaluation of a Topical Medical Device Based on SHBF in Management of Radiodermatitis. An Observer-masked, Controlled Study.

Conditions
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Radiodermatitis, Dermatitis, Radiation-Induced

Intervention / Treatment
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* Device: DermoRelizema cream
* Device: Dexeryl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who give their written consent for participation in the study and willing to comply with all its procedures. Age ≥18 years. Women with breast cancer at any stage who have undergone quadrantectomy, for whom hypofractionated adjuvant RT of the thoracic region is indicated. RTOG/ EORTC radiodermatitis grade equal to 0 (zero) and good cutaneous trophism, in the region to be treated, according to investigator's judgement. Patients who are supposed to be cooperative with regard to compliance with study-related constraints. Exclusion Criteria: Pregnant or lactating women (as not eligible to RT), and fertile women not following, at the investigators' judgement, an adequate contraceptive method. Subjects incapable of giving consent. Concomitant inflammatory skin diseases in acute phase such as: atopic dermatitis, contact dermatitis, psoriasis, lichen planus, pityriasis rosea. Collagen vascular disease, vasculitis, scleroderma, dermatomyositis, or systemic lupus erythematosus. Unhealed surgical sites, breast infections. Bilateral breast cancer or multiple neoplasia needing other independent RT treatments. Prior breast reconstructions, implants, and/or expanders. Known radio-sensitivity syndromes (e.g. ataxia-telangiectasia). Known history of intolerance or hypersensitivity to any ingredient of the study products. Previous RT in the same or different location. Topical pharmacological and medical device treatments on the skin region affected by the RT, in the last 2 weeks. Systemic or topical (including inhaled or intranasal) treatments containing corticosteroids of any class in the 2 days preceding the enrolment. Photo-therapy (PUVA, UVB) in the 2 weeks preceding the enrolment and/or planned to be administered during the course of the study. Participation in another clinical trial at the time of the randomization or within 28 days before randomization. Patient's difficulties or problems, in the judgment of the investigator, in being compliant with study procedures and requirements, including social or mental constrains.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a post marketing, interventional, randomized, single-center, prospective, controlled study. Assessments and evaluations will be performed by a physician in a blind fashion.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DermoRelizema cream<br>The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end | Device: DermoRelizema cream<br>* Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment<br>|
| Active Comparator: Dexeryl<br>The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total). | Device: Dexeryl<br>* FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression of Radio therapy-induced skin reactions using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity | two weeks after the last RT sessiont,day 35-42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression of Radio therapy-induced skin reactions using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | 1. Evaluation of the effects of DermoRelizemaTM cream, in the management of the progression of RT-induced skin reactions and toxicity, using the (RTOG/ EORTC) at the conclusion of the radiotherapy treatment (V2) and at study end (V4) | at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56 | 
| Evaluation of the radiation symptoms reported by the patient in a dialy diary | 2. Evaluation of dermatitis symptoms management (pain at site, itch at site, burning at site and tenderness at site) | up to 1 year | 
| severity of Radio therapy-induced skin reactions using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | 3. Evaluation of the severity of radiation dermatitis by the investigator using the RTOG/ EORTC, at visits 2, 3 and 4 | all study visits, day 21-28, day 35-42 and at the study end (day 49-56) | 
| severity of radiation dermatitis with Radiation Dermatitis Severity (RDS) scoring scale | 4. Evaluation of the severity of radiation dermatitis by the investigator using the Radiation Dermatitis Severity (RDS) scoring scale | all study visits, day 21-28, day 35-42 and at the study end (day 49-56) | 
| assessments of skin damage with OCT (Optical coherence tomography) through evaluation of physiological parameter | Objective instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters, | all study visits, day 21-28, day 35-42 and at the study end (day 49-56) | 
| Patient opinion on cream with a Likert scale | Overall patient's opinion on the products' pleasantness | up to 1 year | 
| Patient's adherence to treatment by complete a dialy diary | Patient's adherence to treatment | up to 1 year | 
| Occurrence of Adverse Events | Occurrence of Adverse Events | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiodermatitis, DermoRelizema cream, DRESDA, Sodium Hyaluronate Butyrate Formiate, RELIFE