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Studies

Interventional Recruiting

NCT06148090 on ClinicalTrials.gov

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

Official title: Screening for Adrenal Insufficiency During Dermocorticoid Reduction in Bullous Pemphigoid

  • Sponsor: Hôpital Saint-André
  • Enrollment: 50 (Estimated)
  • Study start: 2024-01-04 (Actual)
  • Primary completion: 2026-01-01 (Estimated)
  • Study completion: 2026-01-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: At two occasions during the clobetasol decreasing, cortisol and ionogram 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 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)
  • Masking: None
  • PrimaryPurpose: Prevention

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 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.

Conditions

  • Pemphigoid, Bullous
  • Adrenal Insufficiency

Intervention / Treatment

  • Diagnostic Test: clobetasol decreasing measurement

Primary Outcome Measures

  • Measure of cortisol concentration in serum (Month 1)
    Cortisol concentration in serum, after at least 1 month treatment with 20-40g of clobetasol twice a week
  • Measure of cortisol concentration in serum (Month 2)
    Cortisol concentration in serum, after at least 1 month treatment with 20-40g of clobetasol one a week
  • Measure of cortisol concentration in serum after Adreno CorticoTropic Hormone (ACTH) stimulation test (Synacthen®) (Month 1)
    ACTH stimulation test is necessary if serum cortisol concentration is found between 138 and 500 nmol/L
  • Measure of cortisol concentration in serum after ACTH stimulation test (Synacthen®) (Month 2)
    ACTH stimulation test is necessary if serum cortisol concentration is found between 138 and 500 nmol/L

Countries

France

Locations and Investigators

  • University Hospital of Bordeaux - Hospital Saint André, Bordeaux, France (Recruiting)
  • CH de Libourne, Libourne, France (Recruiting)
    • Marie-Laure BOUYSSOU-GAUTHIER, MD
    • Marie-Laure BOUYSSOU-GAUTHIER, MD (Principal Investigator)
    • Alyssa BENARFA, MD
  • CHU de Limoges, Limoges, France (Recruiting)
    • Jean-Philippe BERNARD, MD
    • Jean-Philippe BERNARD, MD (Principal Investigator)
    • Emilie MIO BERTOLO, MD
  • Hôpital Saint louis, Paris, France (Recruiting)
    • Emmanuelle TANCREDE-BOHIN, MD
    • Emmanuelle TANCREDE-BOHIN, MD (Principal Investigator)
    • Clemence LEPELLETIER-BEAUFOND, MD
  • CHU de Rouen, Rouen, France (Recruiting)
    • Pascal JOLY, MD, PhD
    • Pascal JOLY, MD, PhD (Principal Investigator)
    • Julie BOUTEILLER, MD
    • Vivien HEBBERT, MD
    • Billal TEDBIRT, MD

Study Officials