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Does a potent steroid cream cause fluid retention? new study investigates

NCT ID NCT02360202

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study measured fluid retention in 30 people with bullous pemphigoid who were treated with a strong steroid cream (clobetasol propionate). Researchers used bioimpedance to track changes in body water over 30 days. The goal was to understand if the cream causes fluid buildup and whether dietary changes like salt restriction might be helpful.

What this could mean

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

Active substance
clobetasol propionate cream
What this could lead to
If successful, this could clarify whether a salt-free diet is needed during treatment with strong topical steroids for bullous pemphigoid.
What could go wrong
This is a small, completed Phase 4 study with only 30 participants, so results may not apply broadly. It measures fluid changes, not treatment effectiveness or safety.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

30 people

The number who actually took part.

Started

Feb 2015

Finished

Feb 2017

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

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: * Patient with age higher than 18 * Patient with bullous pemphigoid, * Patient treated by local corticosteroid therapy (clobetasol propionate cream) but not yet processed or for less than 48 hours, * Signed informed consent. * Patient affiliated to Social Security Regimen * Effective contraception in women of childbearing age (for postmenopausal women, confirmatory diagnosis of menopause will be collected) Exclusion Criteria: * Concomitant treatment with corticosteroids * Recent introduction or recent (\<6 weeks) treatment with diuretics, angiotensin-converting enzyme, receptor antagonist or anti-angiotensin renin (aliskiren) * contraindication to the use of Clobetasol propionate (DERMOVAL and CLARELUX) * Patient on salt diet (\<or = to 5 g / d) * Patients carry a defibrillator or a pace maker * Amputated Patient * Pregnant and lactating * Patient with Urinary Incontinency * Recent heart decompensation in the last 6 weeks * known Nephrotic Syndrome * known or Severe hepatic impairment * Hypoalbuminaemia less than 20 g / l

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Rouen University Hospital

    Rouen, 76031, France

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