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Study reveals bone risks from common skin treatment
NCT ID NCT03926377
First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 4 times
Summary
This study looked at 47 people with bullous pemphigoid, a blistering skin condition, who were treated with high-dose topical corticosteroids (clobetasol propionate) for 6 months. Researchers measured bone mineral density at the start, at 3 months, and at 6 months to see if the treatment weakened bones. The goal was to understand the side effects of this standard therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- clobetasol propionate (topical corticosteroid)
- What this could lead to
- If successful, this could help doctors understand the bone health risks of long-term topical steroid use in bullous pemphigoid patients.
- What could go wrong
- This is a small, completed Phase 4 study with only 47 participants, so results may not apply broadly. It measures bone density changes but does not test a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
50 people
The number who actually took part.
- Started
-
Dec 2020
- Finished
-
Mar 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria : * 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. Exclusion Criteria : * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU Amiens
Amiens, 80480, France
-
CHU Rouen
Rouen, 76031, France
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