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Completed

NCT Number: NCT02839473

Hydrosorb® Versus Control 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Dermatitis Neoplasms Neoplasms by Site Radiation Dermatitis Radiation Injuries Radiodermatitis Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Institut Curie, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Castalie water spray

Device

Hydrogel Hydrosorb®

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. skin colorimetry measured by a colorimeter

    Time frame: day0, day 7, day 14, day 21, day 28

  2. pain level assessed by the visual analog pain scale

    Time frame: day0, day 7, day 14, day 21, day 28

  3. quality of life assessed with the Dermatology Life Quality Index questionnaire

    Time frame: day0, day 14, day 28

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Collaborators

  • Paul Hartmann

Registry information

Official study title

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

Acronym: HYDROSORB

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 21, 2016
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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