Radiation DermatitisEVOSKINNCT02334345
Skin Protection During Radiotherapy in Patients With Breast Cancer
A study testing Evoskin and Trixiera in people with Radiation Dermatitis, run by University Hospital, Limoges at 1 site in France.
Trial summary
Radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- Evoskin and Trixiera
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to 17 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 years old or more
- Patients with breast cancer for which a treatment by radiotherapy is planned
- No concomitant chemotherapy
- Signed informed consent
Who cannot join
- Cutaneous neoplasia radiotherapy
- Total mastectomy
- Bilateral breast cancer
- Dark skinDiseases enhancing radiosensitivity Patient with a generalized skin disorder
- Pregnant, breast-feeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skin Protection During Radiotherapy in Patients With Breast Cancer: A Comparative Study of Evoskin® Verus Trixéra®
Radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value of the topical treatments of the irradiated skin is lacking. In the present study we investigated the effects of two topical agents used as supportive care to protect skin during radiotherapy.
Read the detailed description
Women with breast cancer and were to receive breast radiotherapy to 50 Gy were enrolled in a prospective randomized trial to compare the effectiveness of Evoskin®) for protecting skin compared to Trixiera. To account for individual differences in radiation each subject served as her own control, as each was to apply the experimental and control agents to the irradiated breast. Each patient was randomly assigned to use Evoskin on the half of the irradiated breast and to use the Triexiera on the other half. Dermatitis was graded weekly by means of a spectrophotometer.
- Conditions
- Radiation Dermatitis
- Being tested
- Evoskin, Trixiera
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvoskinDrug
Evoskin is Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions
TrixieraDrug
Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions
| Study group | Role | What they receive |
|---|---|---|
| EVOSKIN | Experimental | Patients are to apply Evoskin ( topical agent) in the half of the irradiated breast 3 hours after radiothérapy and may be applied again later the same day. Receives: Drug: Evoskin |
| TRIXIERA | Active comparator | Patients are to apply Trixiera ( topical agent) in the other half of the irradiated breast 3 hours after radiothérapy and may be applied again later the same day. Receives: Drug: Trixiera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average of the radiation dermatitis intensity
Radiation dermatitis will be assessed by means of a spectrophotometer after the patient has received 50Gy
Measured: at 3 months
Secondary outcomes (1)
Clinical grade of dermatitis
dermatitis grade will be assessed according to CTCAE after the patient has received 50 Gy
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startJan 2015
- Primary completion1 Nov 2015
- Study completion17 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre CLAVRE, MD, Principal investigator, CHU LIMOGES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334345
- Sponsor's protocol ID
- I13026
- Acronym
- EVOSKIN
- Status last verified
- Feb 2022
- First submitted
- 16 Dec 2014
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Protection During Radiotherapy in Patients With Breast Cancer: A Comparative Study of Evoskin® Verus Trixéra®
- ClinicalTrials.gov ID
- NCT02334345
- Acronym / sponsor ID
- EVOSKIN / I13026
- Conditions
- Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 1 Nov 2015 (actual)
- Study completion
- 17 Jan 2021 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value of the topical treatments of the irradiated skin is lacking. In the present study we investigated the effects of two topical agents used as supportive care to protect skin during radiotherapy.
Detailed description
Women with breast cancer and were to receive breast radiotherapy to 50 Gy were enrolled in a prospective randomized trial to compare the effectiveness of Evoskin®) for protecting skin compared to Trixiera. To account for individual differences in radiation each subject served as her own control, as each was to apply the experimental and control agents to the irradiated breast. Each patient was randomly assigned to use Evoskin on the half of the irradiated breast and to use the Triexiera on the other half. Dermatitis was graded weekly by means of a spectrophotometer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVOSKIN | Experimental | Drug: EvoskinPatients are to apply Evoskin ( topical agent) in the half of the irradiated breast 3 hours after radiothérapy and may be applied again later the same day. |
| TRIXIERA | Active comparator | Drug: TrixieraPatients are to apply Trixiera ( topical agent) in the other half of the irradiated breast 3 hours after radiothérapy and may be applied again later the same day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or more
- Patients with breast cancer for which a treatment by radiotherapy is planned
- No concomitant chemotherapy
- Signed informed consent
Key exclusion criteria (5 listed)
- Cutaneous neoplasia radiotherapy
- Total mastectomy
- Bilateral breast cancer
- Dark skinDiseases enhancing radiosensitivity Patient with a generalized skin disorder
- Pregnant, breast-feeding woman
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 |
|---|---|---|
| EvoskinEvoskin is Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions | Drug | EVOSKIN |
| TrixieraTrixiera is a topical agent recommended to help patients in the management of radiation skin reactions | Drug | TRIXIERA |
Primary outcome
Average of the radiation dermatitis intensity
Time frame: at 3 months
Radiation dermatitis will be assessed by means of a spectrophotometer after the patient has received 50Gy
1 secondary outcome
Clinical grade of dermatitis
Time frame: at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
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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.
Pierre CLAVRE, MD principal investigator
CHU LIMOGES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evoskin and Trixiera in people with Radiation Dermatitis, run by University Hospital, Limoges at 1 site in France.
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 4 inclusion and 5 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 14 Mar 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average of the radiation dermatitis intensity (time frame: at 3 months). 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 14 Mar 2022.