OsteoporosisPhase 4DERMOSNCT03926377
Influence of Dermocorticoids on Bone Mineral Density in Patients With Bullous Pemphigoid
A Phase 4 study testing bone densitometry, blood test and radiographs of the thoracic and lumbar spine in people with Osteoporosis and Bullous Pemphigoid, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
Trial summary
Bullous pemphigoid is the most common type of bullous skin disease and is clinically characterized by clear-tense bullae, which result in post-bullous cutaneous erosions, altering the skin barrier. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Bullous Pemphigoid
- What is being tested?
- bone densitometry, blood test and radiographs of the thoracic and lumbar spine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Dec 2020to 4 Mar 2026
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 years
- Patients with newly diagnosed bullous pemphigoid (BP), treated according to the national diagnostic and care protocol issued by the French Reference Center for Autoimmune Bullous Diseases in April 2016.
- In patients for whom lumbar spine bone densitometry cannot be interpreted at several vertebral levels from L1 to L4 (severe lumbar osteoarthritis, history of lumbar vertebroplasty, osteosynthesis hardware), the data will be interpreted using the remaining evaluable vertebrae. If the BMD of none of the vertebrae from L1 to L4 is evaluable, only hip BMD will be interpreted.
- Patients, or their legal representative, who have received written and oral information and have signed an informed consent form.
- Social Security affiliation.
Who cannot join
- Patients receiving anti-osteoporotic maintenance treatment (zoledronic acid, risedronate, alendronate, pamidronate, ibandronate, teriparatide, denosumab, raloxifene).
- Patients requiring immediate initiation of anti-osteoporotic maintenance treatment (T-score < -3 SD at at least one site or FRAX® score above the therapeutic intervention threshold).
- Patients presenting with one or more major risk factors for osteoporosis:
- In men and premenopausal women: newly diagnosed or radiologically confirmed vertebral fracture without an obvious traumatic or tumor-related context; personal history of a peripheral fracture occurring without major trauma; systemic corticosteroid therapy prescribed for at least three consecutive months at a dose ≥ 7.5 mg/day prednisone equivalent; prolonged hypogonadism; untreated active hyperthyroidism; hypercortisolism; primary hyperparathyroidism; and osteogenesis imperfecta.
- In postmenopausal women: premature menopause < 40 years of age; BMI < 19 kg/m²; parental history of femoral neck fracture without major trauma in a first-degree relative; history of corticosteroid therapy for at least three consecutive months at a dose ≥ 7.5 mg/day prednisone equivalent.
- Patients who have received topical corticosteroids for more than one week during the two weeks preceding inclusion.
Trial locations and contacts
2 sites in 1 country.
About this study
Bullous pemphigoid is the most common type of bullous skin disease and is clinically characterized by clear-tense bullae, which result in post-bullous cutaneous erosions, altering the skin barrier. The treatment of this pathology consists of the application of high doses of topical corticosteroids (clobetasol propionate) for a prolonged period of at least 6 months. The main objective of this study is to demonstrate a change in bone mineral density at 6 months after initiation of treatment, in subjects with bullous pemphigoid and treated with topical corticosteroid.
Read the detailed description
Glucocorticoids have direct effects on bone remodeling by suppressing bone formation (inhibition of osteoblastic differentiation, inhibition of mature osteoblasts function and apoptosis of mature osteoblasts) and by increasing bone resorption (decrease in osteoclast apoptosis and stimulation of osteoclastogenesis). They also have indirect bone effects by decreasing the intestinal absorption of calcium and increasing its urinary excretion, and by inhibiting the somatotropic and gonadotropic axis. This pathophysiology results in excessive bone fragility. Bone loss and increased incidence of fractures occur within 6 months after the introduction of oral corticosteroid therapy, with a partially reversible phenomenon within months of discontinuation. The extent of bone loss depends on the dose and duration of glucocorticoid administration.
The systemic transition of topical corticosteroids depends on several parameters such as excipients, anatomical location, cutaneous state, the dose used and the duration of exposure.
Clobetasol propionate, used for long-term use in bullous pemphigoid, is a Class IV dermocorticoid (highly potent). Patients with bullous pemphigoid will benefit from bone densitometry at the initiation of treatment, at 3 months (theoretical end of the treatment of attack) and at 6 months (theoretical end of the treatment).
Patients will also benefit a blood test of serum calcium, phosphoremia, albumin, 25 OH vitamin D and cortisol at 8 to highlight possible correlations between changes in bone mineral density and phosphocalcic parameters and 8 cortisolemia (braking of the hypothalamic-pituitary-adrenal axis).
Patients will also benefit from standard radiographs of the thoracic and lumbar spine at the initiation of treatment and at 6 months. Follow-up is planned over 6 months, with 2 follow-up visits at 3 months and 6 months.
- Conditions
- Osteoporosis, Bullous Pemphigoid
- Being tested
- bone densitometry, blood test, radiographs of the thoracic and lumbar spine, Clobetasol propionate
- Keywords
- osteoporosis, dermocortocoids, bullous pemphigoid, pharmacoepidemiology
- Medical subject headings
- Osteoporosis, Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone densitometryProcedure or surgery
Patients with bullous pemphigoid will benefit from bone densitometry at the initiation of treatment, at 3 months (theoretical end of the treatment of attack) and at 6 months (theoretical end of the treatment).
blood testBiological
Blood test of serum calcium, phosphoremia, albumin, 25 OH vitamin D and cortisol at 8 hours to highlight possible correlations between changes in bone mineral density and phosphocalcic parameters and 8 hours cortisolemia.
radiographs of the thoracic and lumbar spineProcedure or surgery
standard radiographs of the thoracic and lumbar spine will be done at the initiation of treatment and at 6 months.
Clobetasol propionateProcedure or surgery
Clobetasol propionate (Dermoval® 0,05% cream), administered for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Clobetasol propionate treatment | Other | Clobetasol propionate (Dermoval® 0,05% cream), administered for 6 months. Receives: Procedure: bone densitometry; Biological: blood test; Procedure: radiographs of the thoracic and lumbar spine; Procedure: Clobetasol propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the bone mineral density (BMD) expressed in g/cm² at the lumbar spine between baseline and the theorical end of the treatment.
Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from bone densitometry at the initiation of the treatment and at 6 months (theoretical end of the treatment).
Measured: 6 months after beginning of the treatment
Secondary outcomes (6)
Variation of the bone mineral density (BMD) expressed in g/cm² at the lumbar spine between baseline and the theorical end of the treatment of attack.
Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from bone densitometry at the initiation of the treatment and at 3 months (theoretical end of the treatment of attack).
Measured: 3 months after beginning of the treatment
Variation of the bone mineral density (BMD) expressed in g/cm² at the hip between baseline and the theorical end of the treatment of attack.
Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from bone densitometry at the hip at the initiation of the treatment and at 3 months (theoretical end of the treatment of attack).
Measured: 3 months after beginning of the treatment
Variation of the bone mineral density (BMD) expressed in g/cm² at the hip between baseline and the theorical end of the treatment.
Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from bone densitometry at the hip at the initiation of the treatment and at 6 months (theoretical end of the treatment).
Measured: 6 months after beginning of the treatment
Variation in plasma concentrations of corrected calcemia, phosphoremia, 25 OH vitamin D and cortisolemia between Baseline and the theorical end of the treatment of attack.
Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from a blood test of serum calcium, phosphoremia, albumin, 25 OH vitamin D and cortisol at 8h at the initiation of the treatment and at 3 months (theoretical end of the treatment attack).
Measured: 3 months after beginning of the treatment
Variation in plasma concentrations of corrected calcemia, phosphoremia, 25 OH vitamin D and cortisolemia between Baseline and the theorical end of the treatment.
Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from a blood test of serum calcium, phosphoremia, albumin, 25 OH vitamin D and cortisol at 8h at the initiation of the treatment and at 6 months (theoretical end of the treatment).
Measured: 6 months after beginning of the treatment
frequency of fractures (axial and , or peripheral)
Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from standard radiographs of the thoracic and lumbar spine at the initiation of the treatment and at 6 months (theoretical end of the treatment).
Measured: 6 months after beginning of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start11 Dec 2020
- Primary completion22 Oct 2025
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen
- Responsible party
- Sponsor
- Investigators
- Benjamin Batteux, MD, Principal investigator, CHU AmiensCatherine Lok, Pr, Principal investigator, CHU AmiensPascal Joly, Pr, Principal investigator, CHU Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926377
- Sponsor's protocol ID
- PI2018_843_0040
- Acronym
- DERMOS
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2019
- Last updated
- 8 Sep 2026
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Dermocorticoids on Bone Mineral Density in Patients With Bullous Pemphigoid
- ClinicalTrials.gov ID
- NCT03926377
- Acronym / sponsor ID
- DERMOS / PI2018_843_0040
- Conditions
- Osteoporosis, Bullous Pemphigoid
- Keywords
- osteoporosis, dermocortocoids, bullous pemphigoid, pharmacoepidemiology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Rouen
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 24 Apr 2019 (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.
Bullous pemphigoid is the most common type of bullous skin disease and is clinically characterized by clear-tense bullae, which result in post-bullous cutaneous erosions, altering the skin barrier. The treatment of this pathology consists of the application of high doses of topical corticosteroids (clobetasol propionate) for a prolonged period of at least 6 months. The main objective of this study is to demonstrate a change in bone mineral density at 6 months after initiation of treatment, in subjects with bullous pemphigoid and treated with topical corticosteroid.
Detailed description
Glucocorticoids have direct effects on bone remodeling by suppressing bone formation (inhibition of osteoblastic differentiation, inhibition of mature osteoblasts function and apoptosis of mature osteoblasts) and by increasing bone resorption (decrease in osteoclast apoptosis and stimulation of osteoclastogenesis). They also have indirect bone effects by decreasing the intestinal absorption of calcium and increasing its urinary excretion, and by inhibiting the somatotropic and gonadotropic axis. This pathophysiology results in excessive bone fragility. Bone loss and increased incidence of fractures occur within 6 months after the introduction of oral corticosteroid therapy, with a partially reversible phenomenon within months of discontinuation. The extent of bone loss depends on the dose and duration of glucocorticoid administration.
The systemic transition of topical corticosteroids depends on several parameters such as excipients, anatomical location, cutaneous state, the dose used and the duration of exposure.
Clobetasol propionate, used for long-term use in bullous pemphigoid, is a Class IV dermocorticoid (highly potent). Patients with bullous pemphigoid will benefit from bone densitometry at the initiation of treatment, at 3 months (theoretical end of the treatment of attack) and at 6 months (theoretical end of the treatment).
Patients will also benefit a blood test of serum calcium, phosphoremia, albumin, 25 OH vitamin D and cortisol at 8 to highlight possible correlations between changes in bone mineral density and phosphocalcic parameters and 8 cortisolemia (braking of the hypothalamic-pituitary-adrenal axis).
Patients will also benefit from standard radiographs of the thoracic and lumbar spine at the initiation of treatment and at 6 months. Follow-up is planned over 6 months, with 2 follow-up visits at 3 months and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clobetasol propionate treatment | Other | Procedure: bone densitometry, Biological: blood test, Procedure: radiographs of the thoracic and lumbar spine, Procedure: Clobetasol propionateClobetasol propionate (Dermoval® 0,05% cream), administered for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged ≥ 18 years
- Patients with newly diagnosed bullous pemphigoid (BP), treated according to the national diagnostic and care protocol issued by the French Reference Center for Autoimmune Bullous Diseases in April 2016.
- In patients for whom lumbar spine bone densitometry cannot be interpreted at several vertebral levels from L1 to L4 (severe lumbar osteoarthritis, history of lumbar vertebroplasty, osteosynthesis hardware), the data will be interpreted using the remaining evaluable vertebrae. If the BMD of none of the vertebrae from L1 to L4 is evaluable, only hip BMD will be interpreted.
- Patients, or their legal representative, who have received written and oral information and have signed an informed consent form.
- Social Security affiliation.
Key exclusion criteria (6 listed)
- Patients receiving anti-osteoporotic maintenance treatment (zoledronic acid, risedronate, alendronate, pamidronate, ibandronate, teriparatide, denosumab, raloxifene).
- Patients requiring immediate initiation of anti-osteoporotic maintenance treatment (T-score < -3 SD at at least one site or FRAX® score above the therapeutic intervention threshold).
- Patients presenting with one or more major risk factors for osteoporosis:
- In men and premenopausal women: newly diagnosed or radiologically confirmed vertebral fracture without an obvious traumatic or tumor-related context; personal history of a peripheral fracture occurring without major trauma; systemic corticosteroid therapy prescribed for at least three consecutive months at a dose ≥ 7.5 mg/day prednisone equivalent; prolonged hypogonadism; untreated active hyperthyroidism; hypercortisolism; primary hyperparathyroidism; and osteogenesis imperfecta.
- In postmenopausal women: premature menopause < 40 years of age; BMI < 19 kg/m²; parental history of femoral neck fracture without major trauma in a first-degree relative; history of corticosteroid therapy for at least three consecutive months at a dose ≥ 7.5 mg/day prednisone equivalent.
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 |
|---|---|---|
| bone densitometryPatients with bullous pemphigoid will benefit from bone densitometry at the initiation of treatment, at 3 months (theoretical end of the treatment of attack) and at 6 months (theoretical end of the treatment). | Procedure or surgery | Clobetasol propionate treatment |
| blood testBlood test of serum calcium, phosphoremia, albumin, 25 OH vitamin D and cortisol at 8 hours to highlight possible correlations between changes in bone mineral density and phosphocalcic parameters and 8 hours cortisolemia. | Biological | Clobetasol propionate treatment |
| radiographs of the thoracic and lumbar spinestandard radiographs of the thoracic and lumbar spine will be done at the initiation of treatment and at 6 months. | Procedure or surgery | Clobetasol propionate treatment |
| Clobetasol propionateClobetasol propionate (Dermoval® 0,05% cream), administered for 6 months. | Procedure or surgery | Clobetasol propionate treatment |
Primary outcome
Variation of the bone mineral density (BMD) expressed in g/cm² at the lumbar spine between baseline and the theorical end of the treatment.
Time frame: 6 months after beginning of the treatment
Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from bone densitometry at the initiation of the treatment and at 6 months (theoretical end of the treatment).
6 secondary outcomes
Variation of the bone mineral density (BMD) expressed in g/cm² at the lumbar spine between baseline and the theorical end of the treatment of attack.
Time frame: 3 months after beginning of the treatment
Variation of the bone mineral density (BMD) expressed in g/cm² at the hip between baseline and the theorical end of the treatment of attack.
Time frame: 3 months after beginning of the treatment
Variation of the bone mineral density (BMD) expressed in g/cm² at the hip between baseline and the theorical end of the treatment.
Time frame: 6 months after beginning of the treatment
Variation in plasma concentrations of corrected calcemia, phosphoremia, 25 OH vitamin D and cortisolemia between Baseline and the theorical end of the treatment of attack.
Time frame: 3 months after beginning of the treatment
Variation in plasma concentrations of corrected calcemia, phosphoremia, 25 OH vitamin D and cortisolemia between Baseline and the theorical end of the treatment.
Time frame: 6 months after beginning of the treatment
frequency of fractures (axial and , or peripheral)
Time frame: 6 months after beginning of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- 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.
Benjamin Batteux, MD principal investigator
CHU Amiens
Catherine Lok, Pr principal investigator
CHU Amiens
Pascal Joly, Pr principal investigator
CHU Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bone densitometry, blood test and radiographs of the thoracic and lumbar spine in people with Osteoporosis and Bullous Pemphigoid, run by Centre Hospitalier Universitaire, Amiens at 2 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the bone mineral density (BMD) expressed in g/cm² at the lumbar spine between baseline and the theorical end of the treatment. (time frame: 6 months after beginning of the treatment). 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 8 Sep 2026.