Screening for Adrenal Insufficiency During Dermocorticoid Reduction in Bullous Pemphigoid (BP) (NCT06148090) | Clinical Trial Compass
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Screening for Adrenal Insufficiency During Dermocorticoid Reduction in Bullous Pemphigoid (BP)
France50 participantsStarted 2024-01-04
Plain-language summary
The braking of the corticotropic axis is well established during the induction phase of superpotent topical corticosteroid therapy (clobetasol propionate) in bullous pemphigoid (BP). But the evolution of the corticotropic axis in the following months, especially during the tapering of topical steroids has never been studied. The objective of this study is to evaluate the prevalence of adrenal insufficiency during the topical corticosteroid therapy tapering in patients treated according to current recommendations.
The secondary objectives of the study are :
* to evaluate the presence of other clinico-biological signs of adrenal insufficiency (hypotension, hypoglycemia and/or hyponatremia)
* to compare the characteristics of patients with adrenal insufficiency to those without in order to identify potential risk factors for adrenal insufficiency in BP.
Who can participate
Age range
70 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:
* Male or female at least 18 years of age
* BP diagnosis with at least 3 of the following 4 criteria:
* Age greater than 70 years
* Absence of mucosal involvement
* Absence of atrophic scarring
* No predominance of head and neck
* Skin biopsy with subepidermal cleavage and :
* FD with Ig and/or C3 deposits along the basement membrane
* And/or positive serum anti-BP180 and/or anti-BP230 antibodies
* Treated with clobetasol propionate, with or without background treatment (methotrexate, mycophenolate mofetil, IV Ig, omalizumab, rituximab)
* Treatment with clobetasol propionate 0.05%, 20 to 40 g per application, twice a week for at least one month
* Affiliated to a social security regimen ( without AME)
* Free, informed and expressed consent (confirmed in writing)
Exclusion Criteria:
* Old or ongoing adrenal insufficiency
* Systemic corticosteroid therapy of more than 1 month in the previous 3 months and/or more than 3 months in the previous 12 months, or in the 7 days prior to the cortisol test
* Immuno-induced bullous pemphigoid (anti-PD1, PDL1 and/or anti-CTLA4)
* Impossible to perform a blood test between 7:30 and 8:30 am
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.
What they're measuring
1
Measure of cortisol concentration in serum
Timeframe: Month 1
2
Measure of cortisol concentration in serum
Timeframe: Month 2
3
Measure of cortisol concentration in serum after Adreno CorticoTropic Hormone (ACTH) stimulation test (Synacthen®)
Timeframe: Month 1
4
Measure of cortisol concentration in serum after ACTH stimulation test (Synacthen®)