NCT03926377CompletedPhase 4
Influence of Dermocorticoids on Bone Mineral Density in Patients With Bullous Pemphigoid
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 15 Apr 2019
- Start date
- 11 Dec 2020
- Primary completion date
- 22 Oct 2025
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Diseases
- Osteoporosis
- NCT number
- NCT03926377
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 50
- From 11 Dec 2020 to the primary completion date, 22 Oct 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving anti-osteoporotic maintenance treatment (zoledronic acid, risedronate, alendronate, pamidronate, ibandronate, teriparatide, denosumab, raloxifene).
- Patients who have received topical corticosteroids for more than one week during the two weeks preceding inclusion.
Other illness
- 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.
Age
- 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.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| CHU Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.