Study on the Effect of Clobetasol Propionate on Bone Mineral Density in Patients with Bullous Pemphigoid

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for a skin condition called bullous pemphigoid. This condition is characterized by large, fluid-filled blisters on the skin. The treatment being studied is a cream containing clobetasol propionate, which is a type of medication known as a topical corticosteroid. These medications are often used to reduce inflammation and relieve symptoms in various skin conditions.

The purpose of the study is to understand how using this cream over a period of six months might affect the bone mineral density of patients with bullous pemphigoid. Bone mineral density is a measure of the strength of bones, and it is important for overall bone health. The study will involve regular check-ups to monitor changes in bone mineral density, particularly in the spine and hip areas, as well as other health indicators like calcium and vitamin D levels in the blood.

Participants in the study will apply the clobetasol propionate cream to their skin as directed and will have their bone mineral density measured at the start of the study, after three months, and at the end of the six-month treatment period. The study will also look at the frequency of any bone fractures and how these might relate to the use of the cream. This research aims to provide valuable insights into the safety and effects of long-term use of topical corticosteroids in patients with bullous pemphigoid.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older) and a new diagnosis of bullous pemphigoid.

Informed consent is required, which involves receiving both written and oral information about the study.

2 initial assessment

An initial bone mineral density (BMD) test is conducted at the lumbar spine and hip to establish a baseline measurement.

If the lumbar spine BMD cannot be interpreted due to certain conditions, the hip BMD will be used.

3 treatment phase

The treatment involves the use of clobetasol propionate, a topical corticosteroid, applied to the skin.

This treatment is administered over a period of 6 months.

4 midpoint assessment

At 3 months (M3), a follow-up BMD test is conducted to assess any changes in bone density at the lumbar spine and hip.

Blood tests are performed to measure levels of calcium, phosphorus, vitamin D, and cortisol.

5 final assessment

At the end of the 6-month treatment period (M6), a final BMD test is conducted to evaluate changes in bone density.

Additional blood tests are conducted to reassess the levels of calcium, phosphorus, vitamin D, and cortisol.

The frequency of any fractures is recorded to determine any correlation with corticosteroid exposure.

Who Can Join the Study?

Patients must be 18 years old or older.
Patients should have a newly diagnosed condition called bullous pemphigoid, which is being treated according to a specific national protocol for care.
If a patient’s bone density in the lower back (from L1 to L4 vertebrae) cannot be measured due to issues like severe arthritis or previous surgeries, the study will use the bone density from the remaining vertebrae. If none of these vertebrae can be used, the bone density at the hip will be measured instead.
Patients or their legal representatives must have received both written and spoken information about the study and must have signed a form agreeing to participate, known as informed consent.

Who Cannot Join the Study?

Patients who are currently participating in another clinical trial.
Patients with a history of severe allergic reactions to corticosteroids. Corticosteroids are a type of medication used to reduce inflammation and suppress the immune system.
Patients with other skin conditions that might interfere with the study results.
Patients who have used systemic corticosteroids in the last 3 months. Systemic corticosteroids are medications taken by mouth or injection that affect the whole body.
Patients with significant medical conditions that could affect bone health, such as osteoporosis. Osteoporosis is a condition where bones become weak and are more likely to break.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend scheduled visits.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	11.12.2020

Trial locations

Investigated drugs:

Clobetasol Propionate

Dermoval is a topical corticosteroid used in this study to treat patients with bullous pemphigoid. It is applied to the skin to help reduce inflammation and relieve symptoms such as itching and redness. The study aims to assess how prolonged use of this medication affects bone mineral density in patients.

Bullous pemphigoid – Bullous pemphigoid is a chronic skin condition characterized by large, fluid-filled blisters that primarily appear on areas of the skin that often flex, such as the lower abdomen, upper thighs, or armpits. The blisters are usually not painful but can be itchy. This condition is more common in older adults and is caused by an immune system malfunction where the body mistakenly attacks the tissue just below the outer layer of skin. The blisters can persist for several weeks or months and may heal with some scarring. The disease can have periods of remission and flare-ups, with symptoms varying in intensity over time.

Trial ID:

2024-515676-12-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect of Clobetasol Propionate on Bone Mineral Density in Patients with Bullous Pemphigoid

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?