Status:
RECRUITING
Screening for Adrenal Insufficiency During Dermocorticoid Reduction in Bullous Pemphigoid (BP)
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Pemphigoid, Bullous
Adrenal Insufficiency
Eligibility:
All Genders
70+ years
Phase:
NA
Brief 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...
Detailed Description
BP is the most common autoimmune bullous dermatosis, with 400 incident cases per year in France and an estimated annual mortality rate of 30%. It affects very old and frail patients, with an average a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06148090
Start Date
January 4 2024
End Date
January 1 2026
Last Update
February 20 2024
Active Locations (5)
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1
University Hospital of Bordeaux - Hospital Saint André
Bordeaux, France, 33000
2
CH de Libourne
Libourne, France, 33500
3
CHU de Limoges
Limoges, France, 87000
4
Hôpital Saint louis
Paris, France