N/A
N=70
Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis.
Radiodermatitis · Dermatitis, Radiation-Induced
Bottom Line
View on ClinicalTrials.gov: NCT04483856 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Number of Participants With Progression of Radio Therapy Induced Skin Reaction — 35; 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DermoRelizema cream (Device); Dexeryl (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Relife Italia S.r.l.
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Progression of Radio Therapy Induced Skin Reaction |
30; 28 | — |
| SECONDARY 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) |
27; 26 | — |
| SECONDARY Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results) |
15.56; 17.90; 14.42; 15.79; 15.53; 12.65 | — |
| SECONDARY 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) |
9; 2; 18; 24; 4; 1 | — |
| SECONDARY Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale |
30; 28; 29; 25 | — |
| SECONDARY Number of Participants With Progression of Radio Therapy Induced Skin Reaction |
30; 28 | — |
| SECONDARY Patient Opinion on Cream With a Likert Scale |
18; 15; 30; 27; 30; 28 | — |
| SECONDARY Adherence to Treatment of Patients |
96.50; 97.50 | — |
| SECONDARY Occurrence of Adverse Events |
0; 0 | — |
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
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.
Data sourced from ClinicalTrials.gov (NCT04483856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.