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

March 28, 2023 updated by: Relife Italia S.r.l.

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

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

Study Overview

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

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Modena, Italy, 41134
        • Modena University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DermoRelizema cream
The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
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
Active Comparator: Dexeryl
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).
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).

What is the study measuring?

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)
Time Frame: two weeks after the last RT sessiont,day 35-42
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)
Time Frame: at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56
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
Time Frame: up to 1 year
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)
Time Frame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)
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
Time Frame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)
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
Time Frame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)
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
Time Frame: up to 1 year
Overall patient's opinion on the products' pleasantness
up to 1 year
Patient's adherence to treatment by complete a dialy diary
Time Frame: up to 1 year
Patient's adherence to treatment
up to 1 year
Occurrence of Adverse Events
Time Frame: up to 1 year
Occurrence of Adverse Events
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2020

Primary Completion (Actual)

February 16, 2023

Study Completion (Actual)

February 16, 2023

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

confidential information as per internal procedure of the Sponsor

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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