Hydrosorb® Versus Control in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial (HYDROSORB)

September 15, 2025 updated by: Institut Curie

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75005
        • Institut Curie
      • Saint-Cloud, France, 92210
        • Centre Rene Huguenin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrosorb® arm
Hydrogel Hydrosorb®
Device: Hydrogel Hydrosorb®
Placebo Comparator: Placebo arm
Castalie water spray
Device: Castalie water spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
skin colorimetry measured by a colorimeter
Time Frame: day0, day 7, day 14, day 21, day 28
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
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
day0, day 14, day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Collaborators

Paul Hartmann

Investigators

  • Principal Investigator: Youlia Kirova, MD, Institut Curie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 8, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimated)

July 21, 2016

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2009-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.

IPD Sharing Access Criteria

Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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