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Study reveals bone risks from common skin treatment

NCT ID NCT03926377

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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