Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid (NCT02360202) | Clinical Trial Compass
CompletedPhase 4
Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid
France30 participantsStarted 2015-02-17
Plain-language summary
Clinical observation frequently shows a paradoxical effect of topical corticosteroids in charge of a sudden melting of edema in the first days of treatment, which could be due to mobilization of extracellular. No study has shown the value of this measure in patients treated with topical steroids. This uncertainty, coupled with the observation of the paradoxical effects of topical steroids on edema are some patients that despite the systemic absorption of clobetasol propionate, a salt-free diet is not currently recommended practice.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.