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

NCT06148090 | Recruiting

• 1 other identifier: CHUBX 2023/07
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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

Keywords

Adrenal insufficiency; Iatrogenic; Bullous Pemphigoid; Topical corticosteroids

Outcome Measures

Primary Outcomes (4)

• Measure of cortisol concentration in serum

  Cortisol concentration in serum, after at least 1 month treatment with 20-40g of clobetasol twice a week

  Month 1

• Measure of cortisol concentration in serum

  Cortisol concentration in serum, after at least 1 month treatment with 20-40g of clobetasol one a week

  Month 2

• Measure of cortisol concentration in serum after Adreno CorticoTropic Hormone (ACTH) stimulation test (Synacthen®)

  ACTH stimulation test is necessary if serum cortisol concentration is found between 138 and 500 nmol/L

  Month 1

• Measure of cortisol concentration in serum after ACTH stimulation test (Synacthen®)

  ACTH stimulation test is necessary if serum cortisol concentration is found between 138 and 500 nmol/L

  Month 2

Secondary Outcomes (14)

• Measure of glucose concentration in blood

  Month 1

• Measure of glucose concentration in blood

  Month 2

• Measure of sodium concentration in blood

  Month 1

• Measure of sodium concentration in blood

  Month 2

• Measure of blood pressure

  Month 1

Study Arms (1)

Treated with clobetasol propionate

EXPERIMENTAL

Diagnostic Test: clobetasol decreasing measurement

Interventions

clobetasol decreasing measurement DIAGNOSTIC_TEST

At two occasions during the clobetasol decreasing 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

Treated with clobetasol propionate

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (5)

University Hospital of Bordeaux - Hospital Saint André

Bordeaux, 33000, France

RECRUITING

CH de Libourne

Libourne, 33500, France

RECRUITING

CHU de Limoges

Limoges, 87000, France

RECRUITING

Hôpital Saint louis

Paris, France

RECRUITING

CHU de Rouen

Rouen, 76000, France

RECRUITING

MeSH Terms

Conditions

Pemphigoid, Bullous; Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Anne Pham-Ledard, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Pham-Ledard, MD, PhD

CONTACT

+335 56 79 56 79; anne.pham-ledard@chu-bordeaux.fr

Christine Alfaro

CONTACT

+335 56 79 56 79; christine.alfaro@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 28, 2023
• Study Start: January 4, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)