Screening for Adrenal Insufficiency During Dermocorticoid Reduction in Bullous Pemphigoid (BP)
NCT ID: NCT06148090
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-01-04
2026-01-01
Brief Summary
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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.
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Detailed Description
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High potency topical corticosteroids is the first line therapy, with a high dose applied to the entire tegument for at least 4 months according to current guidelines. In this high potency topical therapy, a braking of the corticotropic axis has been reported during the initial phase of treatment, at the highest doses, explained by the transdermal and systemic passage of dermocorticoids. Monitoring if natural cortisol secretion will start again has never been studied during the tapering of topical corticosteroid therapy, and its under-diagnosis could be deleterious for patients. The French guidelines currently recommends hydrocortisone supplementation at the time of waning from less than 20 g of clobetasol propionate per week, but without any data supporting it.
Prospective multicenter study coordinated by the Bordeaux Dermatology Department and conducted within the French study Group on autoimmune bullous diseases, will aim to include 50 patients with a diagnosis of bullous pemphigoid and treated according to recommendations.
Serum dosage of Cortisol concentration will be measured on two occasions, at the last two steps of the corticosteroid tapering (20-40g, twice a week and 20-40g once a week). If necessary, a Synacthen® test will be performed in addition.
Conditions
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Study Design
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NA
SINGLE_GROUP
* Visit 1: 20-40 g clobetasol twice a week for at least 1 month
* Visit 2: 20-40 g clobetasol once a week for at least 1 month A third visit (visit 3) is necessary if blood cortisol is between 138 and 500 nmol/L, to make a Synacthen® test (new cortisol dosage at 8 AM, then IM or IV injection of a 250 microgram ampoule of Synacthen® completed by a 2nd cortisol dosage one hour later)
PREVENTION
NONE
Study Groups
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Treated with clobetasol propionate
clobetasol decreasing measurement
At two occasions during the clobetasol decreasing measurement at 8 AM and clinical assessment by a physician:
* Visit 1: 20-40 g clobetasol twice a week for at least 1 month
* Visit 2: 20-40 g clobetasol once a week for at least 1 month
Interventions
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clobetasol decreasing measurement
At two occasions during the clobetasol decreasing measurement at 8 AM and clinical assessment by a physician:
* Visit 1: 20-40 g clobetasol twice a week for at least 1 month
* Visit 2: 20-40 g clobetasol once a week for at least 1 month
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
70 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Anne Pham-Ledard, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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University Hospital of Bordeaux - Hospital Saint André
Bordeaux, , France
CH de Libourne
Libourne, , France
CHU de Limoges
Limoges, , France
Hôpital Saint louis
Paris, , France
CHU de Rouen
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHUBX 2023/07
Identifier Type: -
Identifier Source: org_study_id
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