Pemphigoid, BullousPB-DEPISTNCT06148090
Screening for Adrenal Insufficiency During Dermocorticoid Reduction in Bullous Pemphigoid (BP)
A study testing clobetasol decreasing measurement in people with Pemphigoid, Bullous and Adrenal Insufficiency, run by University Hospital, Bordeaux at 5 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Pemphigoid, Bullous, Adrenal Insufficiency
- What is being tested?
- clobetasol decreasing measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesFrance
- Study dates
- 4 Jan 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
University Hospital of Bordeaux - Hospital Saint André
Bordeaux, 33000
Anne PHAM-LEDARD, MD, PhD, +335 56 79 49 52, anne.pham-ledard@chu-bordeaux.fr
Christine ALFARO, +335 56 79 49 52, christine.alfaro@chu-bordeaux.fr
- Recruiting
CH de Libourne
Libourne, 33500
Marie-Laure BOUYSSOU-GAUTHIER, MD, Marie-Laure.Bouyssou-Gauthier@ch-libourne.fr
Marie-Laure BOUYSSOU-GAUTHIER, MD
- Recruiting
CHU de Limoges
Limoges, 87000
Jean-Philippe BERNARD, MD, philippe.bernard@chu-limoges.fr
Jean-Philippe BERNARD, MD
- Recruiting
Hôpital Saint louis
Paris
Emmanuelle TANCREDE-BOHIN, MD, emmanuelle.tancrede-bohin@aphp.fr
Emmanuelle TANCREDE-BOHIN, MD
- Recruiting
CHU de Rouen
Rouen, 76000
Pascal JOLY, MD, PhD, pascal.joly@chu-rouen.fr
Pascal JOLY, MD, PhD
About this study
Official title: Screening for Adrenal Insufficiency During Dermocorticoid Reduction in Bullous Pemphigoid
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.
Read the detailed description
BP is the most common autoimmune bullous dermatosis, with 400 incident cases per year in France and an estimated annual mortality rate of 30%. It affects very old and frail patients, with an average age of 80 years.
High potency topical corticosteroids is the first line therapy, with a high dose applied to the entire tegument for at least 4 months according to current guidelines. In this high potency topical therapy, a braking of the corticotropic axis has been reported during the initial phase of treatment, at the highest doses, explained by the transdermal and systemic passage of dermocorticoids. Monitoring if natural cortisol secretion will start again has never been studied during the tapering of topical corticosteroid therapy, and its under-diagnosis could be deleterious for patients. The French guidelines currently recommends hydrocortisone supplementation at the time of waning from less than 20 g of clobetasol propionate per week, but without any data supporting it.
Prospective multicenter study coordinated by the Bordeaux Dermatology Department and conducted within the French study Group on autoimmune bullous diseases, will aim to include 50 patients with a diagnosis of bullous pemphigoid and treated according to recommendations.
Serum dosage of Cortisol concentration will be measured on two occasions, at the last two steps of the corticosteroid tapering (20-40g, twice a week and 20-40g once a week). If necessary, a Synacthen® test will be performed in addition.
- Conditions
- Pemphigoid, Bullous, Adrenal Insufficiency
- Being tested
- clobetasol decreasing measurement
- Keywords
- Adrenal insufficiency, Iatrogenic, Bullous Pemphigoid, Topical corticosteroids
- Medical subject headings
- Pemphigoid, Bullous, Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clobetasol decreasing measurementDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Treated with clobetasol propionate | Experimental | Not described Receives: Diagnostic Test: clobetasol decreasing measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of cortisol concentration in serum
Cortisol concentration in serum, after at least 1 month treatment with 20-40g of clobetasol twice a week
Measured: 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
Measured: 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
Measured: 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
Measured: Month 2
Secondary outcomes (14)
Measure of glucose concentration in blood
Searching for a biological sign of adrenal insufficiency : hypoglycemia
Measured: Month 1
Measure of glucose concentration in blood
Searching for a biological sign of adrenal insufficiency : hypoglycemia
Measured: Month 2
Measure of sodium concentration in blood
Searching for a biological sign of adrenal insufficiency : hyponatremia
Measured: Month 1
Measure of sodium concentration in blood
Searching for a biological sign of adrenal insufficiency : hyponatremia
Measured: Month 2
Measure of blood pressure
Searching for a clinical sign of adrenal insufficiency : low blood pressure
Measured: Month 1
Measure of blood pressure
Searching for a clinical sign of adrenal insufficiency : low blood pressure
Measured: Month 2
Evaluation of skin atrophy (actinic purpura, skin thinness, post-blister erosion)
Evaluation of skin, looking for factors increasing clobetasol absorption and/or predicting adrenal insufficiency
Measured: Month 1
Evaluation of skin atrophy (actinic purpura, skin thinness, post-blister erosion)
Evaluation of skin, looking for factors increasing clobetasol absorption and/or predicting adrenal insufficiency
Measured: Month 2
Measure of Weight
Evaluating if low body mass index increases clobetasol absorption and/or predicts adrenal insufficiency
Measured: Month 1
Measure of Weight
Evaluating if low body mass index increases clobetasol absorption and/or predicts adrenal insufficiency
Measured: Month 2
Measure of Height
Evaluating if low body mass index increases clobetasol absorption and/or predicts adrenal insufficiency
Measured: Month 1
Measure of Height
Evaluating if low body mass index increases clobetasol absorption and/or predicts adrenal insufficiency
Measured: Month 2
Measure of Quantity of clobetasol applied per week
Evaluating if the risk of adrenal insufficiency depends of the quantity and/or duration of clobetasol treatment
Measured: Month 1
Measure of Quantity of clobetasol applied per week
Evaluating if the risk of adrenal insufficiency depends of the quantity and/or duration of clobetasol treatment
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start4 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pemphigoid, BullousStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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 (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Pham-Ledard, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148090
- Sponsor's protocol ID
- CHUBX 2023/07
- Acronym
- PB-DEPIST
- Status last verified
- Feb 2024
- First submitted
- 17 Nov 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Adrenal Insufficiency During Dermocorticoid Reduction in Bullous Pemphigoid
- ClinicalTrials.gov ID
- NCT06148090
- Acronym / sponsor ID
- PB-DEPIST / CHUBX 2023/07
- Conditions
- Pemphigoid, Bullous, Adrenal Insufficiency
- Keywords
- Adrenal insufficiency, Iatrogenic, Bullous Pemphigoid, Topical corticosteroids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BP is the most common autoimmune bullous dermatosis, with 400 incident cases per year in France and an estimated annual mortality rate of 30%. It affects very old and frail patients, with an average age of 80 years.
High potency topical corticosteroids is the first line therapy, with a high dose applied to the entire tegument for at least 4 months according to current guidelines. In this high potency topical therapy, a braking of the corticotropic axis has been reported during the initial phase of treatment, at the highest doses, explained by the transdermal and systemic passage of dermocorticoids. Monitoring if natural cortisol secretion will start again has never been studied during the tapering of topical corticosteroid therapy, and its under-diagnosis could be deleterious for patients. The French guidelines currently recommends hydrocortisone supplementation at the time of waning from less than 20 g of clobetasol propionate per week, but without any data supporting it.
Prospective multicenter study coordinated by the Bordeaux Dermatology Department and conducted within the French study Group on autoimmune bullous diseases, will aim to include 50 patients with a diagnosis of bullous pemphigoid and treated according to recommendations.
Serum dosage of Cortisol concentration will be measured on two occasions, at the last two steps of the corticosteroid tapering (20-40g, twice a week and 20-40g once a week). If necessary, a Synacthen® test will be performed in addition.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Treated with clobetasol propionate | Experimental | Diagnostic Test: clobetasol decreasing measurement |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- Male or female at least 18 years of age
- BP diagnosis with at least 3 of the following 4 criteria:
- Skin biopsy with subepidermal cleavage and :
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clobetasol decreasing measurementAt 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 | Diagnostic test | Treated with clobetasol propionate |
Primary outcome
Measure of cortisol concentration in serum
Time frame: 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
Time frame: 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®)
Time frame: 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®)
Time frame: Month 2
ACTH stimulation test is necessary if serum cortisol concentration is found between 138 and 500 nmol/L
14 secondary outcomes
Measure of glucose concentration in blood
Time frame: Month 1
Measure of glucose concentration in blood
Time frame: Month 2
Measure of sodium concentration in blood
Time frame: Month 1
Measure of sodium concentration in blood
Time frame: Month 2
Measure of blood pressure
Time frame: Month 1
Measure of blood pressure
Time frame: Month 2
Evaluation of skin atrophy (actinic purpura, skin thinness, post-blister erosion)
Time frame: Month 1
Evaluation of skin atrophy (actinic purpura, skin thinness, post-blister erosion)
Time frame: Month 2
Measure of Weight
Time frame: Month 1
Measure of Weight
Time frame: Month 2
Measure of Height
Time frame: Month 1
Measure of Height
Time frame: Month 2
Measure of Quantity of clobetasol applied per week
Time frame: Month 1
Measure of Quantity of clobetasol applied per week
Time frame: Month 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Pham-Ledard, MD, PhD principal investigator
University Hospital, Bordeaux
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clobetasol decreasing measurement in people with Pemphigoid, Bullous and Adrenal Insufficiency, run by University Hospital, Bordeaux at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Pham-Ledard, MD, PhD (+335 56 79 56 79, anne.pham-ledard@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of cortisol concentration in serum (time frame: Month 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.