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

NCT ID: NCT04483856

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2023-02-16

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

Conditions

Radiodermatitis; Dermatitis, Radiation-Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

DermoRelizema cream

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

Dexeryl

Intervention Type: 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).

Interventions

DermoRelizema cream

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

Dexeryl

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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Relife Italia S.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariangela Francomano

Role: PRINCIPAL_INVESTIGATOR

University of Modena

Locations

Modena University Hospital

Modena, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RELI/19/Der-Rdt/001

Identifier Type: -

Identifier Source: org_study_id