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New hope for painful bandage changes in rare skin disease

NCT ID NCT03730584

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a numbing cream (ropivacaine) can reduce severe pain during bath and dressing changes in children and young adults with epidermolysis bullosa, a rare genetic skin condition. Ten participants applied the cream before dressing changes and reported their pain levels. The goal was to see if pain scores dropped by at least 2 points over five days, aiming to improve quality of life.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

10 people

The number who actually took part.

Started

Feb 2017

Finished

Nov 2019

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

Up to 21 years

Sex

Anyone

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: * Minor patient or adult ≤ 21 years of age with hereditary epidermolysis bullosa, * Presenting pain at the entrance of the bath with an average of EVA or FLACC greater than 4/10 the week before the inclusion * Usually requiring premedication with weak or strong opioid * Parental consent if minor or patient consent * Affiliated with Social Security Exclusion Criteria: * Patient with a known allergy to ROPIVACAINE or other local anesthetics with amide binding or one of the excipients mentioned in the SPC * Severe renal insufficiency defined by DFG below 29ml / min * Moderate to severe hepatic insufficiency defined by a Child-Pugh B or C score and AST or ALAT greater than 3 times normal * Moderate to severe cardiac failure defined by FEGV less than 45% and/or NYHA class II to IV * Hypovolemia

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Conditions

The condition(s) this trial relates to.

epidermolysis bullosa inherited epidermolysis bullosa Pain

As listed by the trial registrant

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

Epidermolysis bullosa

Contacts and locations

Locations

  • Hôpital Necker Enfants Malades

    Paris, 75015, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.