Clinical trial · Interventional
Hydrosorb® Versus Control in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial
Hydrosorb® Versus Control (Water Based Spray) in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial
NCT02839473CI-TRIAL-00095448HYDROSORBcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Castalie water spray | Device | — | UNRESOLVED |
| Hydrogel Hydrosorb® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hydrosorb® arm
- description
- Hydrogel Hydrosorb®
- interventionNames
- Device: Hydrogel Hydrosorb®
- type
- PLACEBO_COMPARATOR
- label
- Placebo arm
- description
- Castalie water spray
- interventionNames
- Device: Castalie water spray
Primary outcomes (1)
- measure
- local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration.
- timeFrame
- through study completion, an average of 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion criteria: * 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.
References
Publications (1)
- RESULTBazire 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. PMID 26328937