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

NCT02839473 | Completed Phase 3

• 1 other identifier: IC 2009-07
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer; Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration.

  through study completion, an average of 3 years

Secondary Outcomes (3)

• skin colorimetry measured by a colorimeter

  day0, day 7, day 14, day 21, day 28

• pain level assessed by the visual analog pain scale

  day0, day 7, day 14, day 21, day 28

• quality of life assessed with the Dermatology Life Quality Index questionnaire

  day0, day 14, day 28

Study Arms (2)

Hydrosorb® arm

EXPERIMENTAL

Hydrogel Hydrosorb®

Device: Hydrogel Hydrosorb®

Placebo arm

PLACEBO COMPARATOR

Castalie water spray

Device: Castalie water spray

Interventions

Castalie water spray DEVICE

Placebo arm

Hydrogel Hydrosorb® DEVICE

Hydrosorb® arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Curie: lead
• Paul Hartmann: collaborator

Study Sites (2)

Institut Curie

Paris, 75005, France

Location

Centre René Huguenin

Saint-Cloud, 92210, France

Location

Related Publications (1)

• 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.

  PMID: 26328937 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Youlia Kirova, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 21, 2016
• Study Start: March 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• 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).

Locations

FR (2)