Breast CancerPhase 3HYDROSORBNCT02839473
Hydrosorb® Versus Control in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial
A Phase 3 study testing Castalie water spray and Hydrogel Hydrosorb® in people with Breast Cancer and Radiation Dermatitis, run by Institut Curie at 2 sites in France.
Trial summary
The primary objective consisted of avoiding deterioration and/or restoring the integrity of the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2 radiation dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Radiation Dermatitis
- What is being tested?
- Castalie water spray and Hydrogel Hydrosorb®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2010to Jul 2014
- Phase
- Phase 3
- 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
- Women treated by normo fractionated radiotherapy for breast cancer
- Presenting grade 1 or 2 radiation dermatitis during the treatment and who provided their written informed consent were included in the study.
Who cannot join
- Were male patients
- Radiation dermatitis already treated or caused by another treatment
- Subjects deprived of their freedom or under guardianship
- Subjects in whom medical follow-up was impossible
- A cancer wound or skin flap on the irradiated zone
- A history of allergic skin reaction
- Concomitant chemotherapy or concomitant bevacizumab therapy and bilateral irradiation.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut Curie
Paris, 75005
Centre René Huguenin
Saint-Cloud, 92210
About this study
Official title: Hydrosorb® Versus Control (Water Based Spray) in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial
The primary objective consisted of avoiding deterioration and/or restoring the integrity of the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2 radiation dermatitis.
- Conditions
- Breast Cancer, Radiation Dermatitis
- Being tested
- Castalie water spray, Hydrogel Hydrosorb®
- Medical subject headings
- Breast Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Castalie water sprayDevice
Hydrogel Hydrosorb®Device
| Study group | Role | What they receive |
|---|---|---|
| Hydrosorb® arm | Experimental | Hydrogel Hydrosorb® Receives: Device: Hydrogel Hydrosorb® |
| Placebo arm | Placebo comparator | Castalie water spray Receives: Device: Castalie water spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration.
Measured: through study completion, an average of 3 years
Secondary outcomes (3)
skin colorimetry measured by a colorimeter
Measured: day0, day 7, day 14, day 21, day 28
pain level assessed by the visual analog pain scale
Measured: day0, day 7, day 14, day 21, day 28
quality of life assessed with the Dermatology Life Quality Index questionnaire
Measured: day0, day 14, day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startMar 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- Paul Hartmann
- Responsible party
- Sponsor
- Investigators
- Youlia Kirova, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839473
- Sponsor's protocol ID
- IC 2009-07
- Acronym
- HYDROSORB
- Status last verified
- Sep 2025
- First submitted
- 8 Jul 2016
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Publications
Bazire L, Fromantin I, Diallo A, de la Lande B, Pernin V, Dendale R, Fourquet A, Savignoni A, Kirova YM. Hydrosorb(R) versus control (water based spray) in the management of radio-induced skin toxicity: Results of multicentre controlled randomized trial. Radiother Oncol. 2015 Nov;117(2):229-33. doi: 10.1016/j.radonc.2015.08.028. Epub 2015 Aug 29.
PubMed 26328937
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrosorb® Versus Control (Water Based Spray) in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial
- ClinicalTrials.gov ID
- NCT02839473
- Acronym / sponsor ID
- HYDROSORB / IC 2009-07
- Conditions
- Breast Cancer, Radiation Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- Paul Hartmann
- Study start
- Mar 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 Jul 2016 (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.
The primary objective consisted of avoiding deterioration and/or restoring the integrity of the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2 radiation dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrosorb® arm | Experimental | Device: Hydrogel Hydrosorb®Hydrogel Hydrosorb® |
| Placebo arm | Placebo comparator | Device: Castalie water sprayCastalie water spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women treated by normo fractionated radiotherapy for breast cancer
- Presenting grade 1 or 2 radiation dermatitis during the treatment and who provided their written informed consent were included in the study.
Key exclusion criteria (7 listed)
- Were male patients
- Radiation dermatitis already treated or caused by another treatment
- Subjects deprived of their freedom or under guardianship
- Subjects in whom medical follow-up was impossible
- A cancer wound or skin flap on the irradiated zone
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 |
|---|---|---|
| Castalie water spray | Device | Placebo arm |
| Hydrogel Hydrosorb® | Device | Hydrosorb® arm |
Primary outcome
local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration.
Time frame: through study completion, an average of 3 years
3 secondary outcomes
skin colorimetry measured by a colorimeter
Time frame: day0, day 7, day 14, day 21, day 28
pain level assessed by the visual analog pain scale
Time frame: day0, day 7, day 14, day 21, day 28
quality of life assessed with the Dermatology Life Quality Index questionnaire
Time frame: day0, day 14, day 28
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 19 Sep 2025.
- Results publication: PubMed 26328937Bazire L, Fromantin I, Diallo A, de la Lande B, Pernin V, Dendale R, Fourquet A, Savignoni A, Kirova YM. Hydrosorb(R) versus control (water based spray) in the management of radio-induced skin toxicity: Results of multicentre controlled randomized trial. Radiother Oncol. 2015 Nov;117(2):229-33. doi: 10.1016/j.radonc.2015.08.028. Epub 2015 Aug 29.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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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.
Youlia Kirova, MD principal investigator
Institut Curie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Castalie water spray and Hydrogel Hydrosorb® in people with Breast Cancer and Radiation Dermatitis, run by Institut Curie at 2 sites 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 2 inclusion and 7 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration. (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02839473, which also lists 1 linked publication.
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 19 Sep 2025.