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Hydrogel or spray? new study tests best way to soothe radiation skin damage

NCT ID NCT02839473

Symptom relief Sponsor: Institut Curie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested two skin treatments—a hydrogel dressing and a water spray—for women with breast cancer who developed skin irritation from radiotherapy. The goal was to see which one better prevented treatment delays or the need to switch care. 278 women with mild to moderate skin burns took part. The results could help improve comfort during cancer treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hydrogel Hydrosorb® (a moist wound dressing) and Castalie water spray
What this could lead to
If it works, this could provide a better way to manage skin irritation during radiotherapy, reducing treatment interruptions and improving comfort.
What could go wrong
This is a completed Phase 3 trial, but the results may show no significant benefit over a simple water spray. The intervention only addresses skin symptoms, not the cancer itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

278 people

The number who actually took part.

Start date

Mar 2010

Finished

Jul 2014

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm radiodermatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Radiation dermatitis

Contacts and locations

Locations

  • Centre René Huguenin

    Saint-Cloud, 92210, France

  • Institut Curie

    Paris, 75005, France

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