AuthorisedTherapeutic use (Phase IV)Interventional

DERMOS study : Influence of dermocorticoids on bone mineral density in patients with bullous pemphigoid.

This research, called the 'DERMOS study', is looking into a common but serious skin condition called bullous pemphigoid. People with this condition often use a powerful skin cream called clobetasol propionate. The study aims to understand if using this particular cream affects how strong their bones are, specifically in the lower back (lumbar spine). Over a six-month period, researchers will measure bone strength at the start and end of treatment to see if there are any changes. They will also check other things like calcium levels and look at whether people have had any bone breaks, all to get a clearer picture of how this cream might be affecting bone health.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Enrolment target

Start

31 Jul 2024

Bullous pemphigoid

What is this study about?

The DERMOS study is investigating a condition called bullous pemphigoid. This is a skin condition where large, fluid-filled blisters develop on the skin. To treat it, doctors often prescribe a strong skin cream, and one of these is called clobetasol propionate. This study wants to find out if using this cream for bullous pemphigoid affects the strength of your bones.

Bone strength is often measured by something called 'bone mineral density'. The researchers will specifically look at your lower back bones (lumbar spine) to see if this density changes over six months of using the cream. They will compare measurements taken at the beginning of the study with those taken after six months of treatment. By doing this, they hope to understand if there's a link between using the skin cream and any changes in bone strength.

Beyond just bone density, the study will also look at whether the total amount of cream used is related to any bone strength changes. They'll also check your hip bones, blood levels of important substances like calcium and vitamin D, and keep track of any bone breaks during the study. This comprehensive approach will help doctors understand the full picture of how this treatment might impact your bone health.

Key takeaways

This study investigates if a skin cream for bullous pemphigoid affects bone strength.
It lasts for six months and involves bone density scans and blood tests.
Participation helps future patients and provides extra bone health monitoring.
You can withdraw from the study at any time without affecting your medical care.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

To be able to join this study, you must be 18 years old or older. The study is open to both men and women.

Further specific criteria would be needed to know if someone is truly eligible, but generally, participants will have been diagnosed with bullous pemphigoid and be receiving treatment with clobetasol propionate.

It's important to discuss your full medical history with the study team to confirm if this study is right for you, as there might be other health conditions or medications that would prevent you from taking part.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of bullous pemphigoid?
Are you currently using clobetasol propionate skin cream?
Are you willing to participate for six months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be involved for a total of six months. At the very beginning, you would have an initial visit where your bone density in your lower back would be measured. This is often done using a special type of X-ray called a DEXA scan. Blood samples would also be taken to check levels of things like calcium and vitamin D.

You would continue your prescribed treatment with the clobetasol propionate skin cream as advised by your doctor. Over the six months, you would have at least two more visits – one around three months and a final one at six months. At these follow-up visits, your bone density would be measured again, and more blood samples would be taken. The study team would also ask about any bone breaks you might have experienced. The total duration of your active participation, including all visits and assessments, would be six months.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. A potential benefit of taking part is contributing valuable information that could help other people with bullous pemphigoid in the future, by improving our understanding of their treatment. For you personally, you might receive additional monitoring of your bone health. Potential risks might include discomfort or very small radiation exposure from the bone density scans, and any minor discomfort from blood tests. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
France

Common questions

What is bullous pemphigoid?

It's a skin condition that causes large, fluid-filled blisters to appear on the skin.

What is bone mineral density?

It's a measurement that tells us how strong and dense your bones are.

What is clobetasol propionate?

It's a strong skin cream often prescribed to treat conditions like bullous pemphigoid.

How long does the study last?

If you participate, the study would last for six months.

Will I have to stop my current treatment?

No, you would continue to use your clobetasol propionate cream as prescribed by your doctor.