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

NCT04483856 | Completed Results

• 1 other identifier: RELI/19/Der-Rdt/001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Radiodermatitis; Dermatitis, Radiation-Induced

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Progression of Radio Therapy Induced Skin Reaction

  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 Outcomes (8)

• 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)

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

• Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results)

  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)

  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

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

• Number of Participants With Progression of Radio Therapy Induced Skin Reaction

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

Study Arms (2)

DermoRelizema cream

EXPERIMENTAL

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

Dexeryl

ACTIVE COMPARATOR

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

Interventions

DermoRelizema cream DEVICE

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

DermoRelizema cream

Dexeryl DEVICE

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).

Dexeryl

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female patient with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Relife Italia S.r.l.: lead

Study Sites (1)

Modena University Hospital

Modena, 41134, Italy

Location

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Results Point of Contact

• Title: Clinical Trials Coordinator
• Organization: Relife Srl

lfabbri@relifecompany.it

05556809528

Study Officials

• Mariangela Francomano

  University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessments and evaluations will be performed by a physician in a blind fashion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 23, 2020
• Study Start: November 2, 2020
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: May 15, 2025
• Results First Posted: May 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)