Screening for Adrenal Insufficiency During Dermocorticoid Reduction in Bullous Pemphigoid

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
University Hospital of Bordeaux - Hospital Saint André
RECRUITING
Bordeaux
CH de Libourne
RECRUITING
Libourne
CHU de Limoges
RECRUITING
Limoges
Hôpital Saint louis
RECRUITING
Paris
CHU de Rouen
RECRUITING
Rouen
Contact Information
Primary
Anne Pham-Ledard, MD, PhD
anne.pham-ledard@chu-bordeaux.fr
+335 56 79 56 79
Backup
Christine Alfaro
christine.alfaro@chu-bordeaux.fr
+335 56 79 56 79
Time Frame
Start Date: 2024-01-04
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 50
Treatments
Experimental: Treated with clobetasol propionate
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov