Evaluating adrenal insufficiency during corticosteroid reduction in bullous pemphigoid patients

Screening for Adrenal Insufficiency During Dermocorticoid Reduction in Bullous Pemphigoid

This study is testing if patients with bullous pemphigoid experience adrenal insufficiency while reducing their use of a steroid cream called clobetasol propionate.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 70 Years and up
• Sex: All
• Sponsor: University Hospital, Bordeaux (other)
• Drugs / interventions: omalizumab, rituximab, methotrexate
• Locations: 5 sites (Bordeaux and 4 other locations)
• Trial ID: NCT06148090 on ClinicalTrials.gov

What this trial studies

This study aims to assess the prevalence of adrenal insufficiency in patients with bullous pemphigoid who are tapering off topical corticosteroids, specifically clobetasol propionate. It will monitor cortisol levels during the tapering process and evaluate other clinical signs of adrenal insufficiency, such as hypotension and hypoglycemia. The study will include 50 patients diagnosed with bullous pemphigoid and treated according to current guidelines, with serum cortisol concentrations measured at key points during the treatment. The findings could provide critical insights into the management of adrenal function in these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with bullous pemphigoid who meet specific clinical criteria and are undergoing treatment with clobetasol propionate.

Not a fit: Patients with pre-existing adrenal insufficiency or those who have received systemic corticosteroid therapy recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring and management of adrenal insufficiency in patients undergoing corticosteroid tapering, enhancing patient safety and outcomes.

How similar studies have performed: While the approach of monitoring adrenal function during corticosteroid tapering is not widely studied, similar investigations in other contexts have shown promising results.

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

Where this trial is running

Bordeaux and 4 other locations

• University Hospital of Bordeaux - Hospital Saint André — Bordeaux, France (RECRUITING)
• CH de Libourne — Libourne, France (RECRUITING)
• CHU de Limoges — Limoges, France (RECRUITING)
• Hôpital Saint louis — Paris, France (RECRUITING)
• CHU de Rouen — Rouen, France (RECRUITING)

Study contacts

• Principal investigator: Anne Pham-Ledard, MD, PhD — University Hospital, Bordeaux
• Study coordinator: Anne Pham-Ledard, MD, PhD

Conditions: Pemphigoid, Bullous, Adrenal Insufficiency, Adrenal insufficiency, Iatrogenic, Bullous Pemphigoid, Topical corticosteroids