Status:
COMPLETED
Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis.
Lead Sponsor:
Relife Italia S.r.l.
Conditions:
Radiodermatitis
Dermatitis, Radiation-Induced
Eligibility:
FEMALE
18+ years
Phase:
NA
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 (Der...
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 (Der...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04483856
Start Date
November 2 2020
End Date
February 16 2023
Last Update
May 15 2025
Active Locations (1)
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1
Modena University Hospital
Modena, Italy, 41134