Screening for Adrenal Insufficiency During Dermocorticoid Reduction in Bullous Pemphigoid (BP)

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Nov 17, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how common adrenal insufficiency (a condition where the adrenal glands don’t produce enough hormones) is in patients with bullous pemphigoid (BP) who are gradually reducing their use of a strong topical steroid called clobetasol propionate. The study aims to see if patients experience any signs of adrenal insufficiency during this tapering process, as well as to identify potential risk factors for those who do develop this condition.

To participate in the trial, individuals must be at least 18 years old, diagnosed with bullous pemphigoid, and have been treated with clobetasol propionate for at least a month. Participants will be asked to provide blood samples to check for adrenal insufficiency and other related signs, and they will receive close monitoring throughout the study. This research is important to better understand how stopping steroid treatment may affect patients and to improve care for those with bullous pemphigoid.

Gender

ALL

Eligibility criteria

• 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