RadiodermatitisDRESDANCT04483856
Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis.
A study testing DermoRelizema cream and Dexeryl in people with Radiodermatitis and Dermatitis, Radiation-Induced, run by Relife Italia S.r.l. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiodermatitis, Dermatitis, Radiation-Induced
- What is being tested?
- DermoRelizema cream and Dexeryl
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 2 Nov 2020to 16 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- DermoRelizema cream, Dexeryl
- Keywords
- Radiodermatitis, DermoRelizema cream, DRESDA, Sodium Hyaluronate Butyrate Formiate, RELIFE
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermoRelizema creamDevice
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
DexerylDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Device: Dexeryl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
- 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)
Measured: 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)
Evaluation of dermatitis symptoms management
Measured: 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)
Evaluation of the severity of radiation dermatitis by the investigator using the RTOG/ EORTC (system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer(grade 0-1: treatment is succesfull, grade 1 or magior: treatment insuccesful) ), at visits 2, 3 and 4
Measured: 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
Evaluation of the severity of radiation dermatitis by the investigator using the Radiation Dermatitis Severity (RDS) scoring scale. The severity of radiation dermatitis was measured using this scoring system, range 0.0 to 4.0 at increments of 0.5. The RDS score incorporates changes in redness, pigment, texture and integrity of the skin ( grade 0: best result, grade 4§: worst result)
Measured: 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
Objective instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters,
Measured: 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
Overall patient's opinion on the products' pleasantness
Measured: up to 1 year
Adherence to Treatment of Patients
Patient's adherence to treatment on a diary's scale ( 10 points, in whitc: 1 is the best, 100 is the worst)
Measured: up to 1 year
Occurrence of Adverse Events
Occurrence of Adverse Events
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start2 Nov 2020
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RadiodermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Relife Italia S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariangela Francomano, Principal investigator, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483856
- Sponsor's protocol ID
- RELI/19/Der-Rdt/001
- Acronym
- DRESDA
- Status last verified
- Apr 2025
- First submitted
- 13 Jul 2020
- Last updated
- 15 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: confidential information as per internal procedure of the Sponsor
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability Evaluation of a Topical Medical Device Based on SHBF in Management of Radiodermatitis. An Observer-masked, Controlled Study.
- ClinicalTrials.gov ID
- NCT04483856
- Acronym / sponsor ID
- DRESDA / RELI/19/Der-Rdt/001
- Conditions
- Radiodermatitis, Dermatitis, Radiation-Induced
- Keywords
- Radiodermatitis, DermoRelizema cream, DRESDA, Sodium Hyaluronate Butyrate Formiate, RELIFE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Relife Italia S.r.l.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Posted 15 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| DermoRelizema cream | Experimental | Device: DermoRelizema creamThe treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end |
| Dexeryl | Active comparator | Device: DexerylThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DermoRelizema creamFingertip 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 | Device | DermoRelizema cream |
| DexerylFTUs 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). | Device | Dexeryl |
Primary outcome
Number of Participants With Progression of Radio Therapy Induced Skin Reaction
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
8 secondary outcomes
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, reported day 56
Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results)
Time frame: 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)
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)
Number of Participants With Progression of Radio Therapy Induced Skin Reaction
Time frame: 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
Adherence to Treatment of Patients
Time frame: up to 1 year
Occurrence of Adverse Events
Time frame: up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. confidential information as per internal procedure of the Sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariangela Francomano principal investigator
University of Modena and Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DermoRelizema cream and Dexeryl in people with Radiodermatitis and Dermatitis, Radiation-Induced, run by Relife Italia S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Progression of Radio Therapy Induced Skin Reaction (time frame: two weeks after the last RT sessiont,day 35-42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.