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

Primary Purpose

Radiodermatitis, Dermatitis, Radiation-Induced

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

DermoRelizema cream

Dexeryl

About this trial

This is an interventional treatment trial for Radiodermatitis focused on measuring Radiodermatitis, DermoRelizema cream, DRESDA, Sodium Hyaluronate Butyrate Formiate, RELIFE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Modena University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DermoRelizema cream

Dexeryl

Arm Description

The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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)

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

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

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,

Patient opinion on cream with a Likert scale

Overall patient's opinion on the products' pleasantness

Patient's adherence to treatment by complete a dialy diary

Patient's adherence to treatment

Occurrence of Adverse Events

Full Information

NCT ID

NCT04483856

First Posted

July 13, 2020

Last Updated

March 28, 2023

Sponsor

Relife Italia S.r.l.

1. Study Identification

Unique Protocol Identification Number

NCT04483856

Brief Title

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

Acronym

DRESDA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

November 2, 2020 (Actual)

Primary Completion Date

February 16, 2023 (Actual)

Study Completion Date

February 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Relife Italia S.r.l.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radiodermatitis, Dermatitis, Radiation-Induced

Keywords

Radiodermatitis, DermoRelizema cream, DRESDA, Sodium Hyaluronate Butyrate Formiate, RELIFE

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Outcomes Assessor

Masking Description

Assessments and evaluations will be performed by a physician in a blind fashion.

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DermoRelizema cream

Arm Type

Experimental

Arm Description

The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end

Arm Title

Dexeryl

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

DermoRelizema cream

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Dexeryl

Intervention Description

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).

Primary Outcome Measure Information:

Title

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)

Description

Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity

Time Frame

two weeks after the last RT sessiont,day 35-42

Secondary Outcome Measure Information:

Title

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)

Description

Time Frame

at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56

Title

Evaluation of the radiation symptoms reported by the patient in a dialy diary

Description

2. Evaluation of dermatitis symptoms management (pain at site, itch at site, burning at site and tenderness at site)

Time Frame

up to 1 year

Title

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)

Description

3. Evaluation of the severity of radiation dermatitis by the investigator using the RTOG/ EORTC, at visits 2, 3 and 4

Time Frame

all study visits, day 21-28, day 35-42 and at the study end (day 49-56)

Title

severity of radiation dermatitis with Radiation Dermatitis Severity (RDS) scoring scale

Description

4. Evaluation of the severity of radiation dermatitis by the investigator using the Radiation Dermatitis Severity (RDS) scoring scale

Time Frame

all study visits, day 21-28, day 35-42 and at the study end (day 49-56)

Title

assessments of skin damage with OCT (Optical coherence tomography) through evaluation of physiological parameter

Description

Objective instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters,

Time Frame

all study visits, day 21-28, day 35-42 and at the study end (day 49-56)

Title

Patient opinion on cream with a Likert scale

Description

Overall patient's opinion on the products' pleasantness

Time Frame

up to 1 year

Title

Patient's adherence to treatment by complete a dialy diary

Description

Patient's adherence to treatment

Time Frame

up to 1 year

Title

Occurrence of Adverse Events

Description

Occurrence of Adverse Events

Time Frame

up to 1 year

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

female patient with breast cancer

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Modena University Hospital

City

Modena

ZIP/Postal Code

41134

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

confidential information as per internal procedure of the Sponsor

Learn more about this trial

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

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