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Study on Sirolimus for Adults with Facial Skin Sarcoidosis: Evaluating Treatment for Moderate to Severe Cases

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Sirolimus on a condition known as sarcoidosis, specifically when it affects the skin on the face. Sarcoidosis is a disease that causes small clusters of inflammatory cells, called granulomas, to form in different parts of the body, including the skin. In this study, the goal is to see how effective Sirolimus is in treating moderate to severe cases of facial skin involvement in sarcoidosis.

Participants in the study will take Sirolimus in the form of a coated tablet, which is taken orally. The study will last for a period of 16 weeks. During this time, researchers will monitor the participants to see if there is a significant improvement in their skin condition. This will be assessed by looking at changes in the appearance of the skin and evaluating the overall quality of life related to their skin condition. The study will also keep track of any side effects that may occur, such as mouth ulcers or changes in blood cell counts.

The purpose of this study is to evaluate the safety and effectiveness of Sirolimus in treating facial skin sarcoidosis. By the end of the study, researchers hope to determine whether Sirolimus can provide a significant clinical response, which means a noticeable improvement in the skin condition of the participants. This information could help in developing better treatment options for people with sarcoidosis affecting the skin on their face.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age and diagnosis of cutaneous sarcoidosis with facial involvement.
Written consent is required to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the severity of facial skin involvement using the SASI (sarcoidosis area and severity index) and PGA (Physician's Global Assessment).
Photographs of the face are taken for macroscopic assessment.
Step 3
Medication administration
The medication sirolimus is administered orally.
The dosage and frequency are determined by the study protocol and are monitored throughout the trial.
Step 4
Treatment period
The treatment period lasts for 16 weeks.
Regular assessments are conducted to monitor the response to treatment and any side effects.
Step 5
Midpoint evaluation
At the midpoint of the treatment, a clinical evaluation is performed to assess the reduction in facial skin involvement.
The SASI and PGA scores are re-evaluated.
Step 6
Final assessment
At the end of the 16-week treatment period, a final assessment is conducted.
The primary endpoint is the percentage of patients with a significant clinical response, defined as a relative decrease in the SASI facial score by at least 25%.
Step 7
Secondary evaluations
Secondary evaluations include assessing the complete clinical response, improvement in dermatological quality of life, and comparison of facial photographs.
Additional assessments may include pulmonary function tests and skin biopsies.
Step 8
Adverse events monitoring
Throughout the study, any adverse events are recorded, including potential side effects such as mouth ulcers and changes in blood cell counts.

Who can join the trial?

7 criteria

Must be an adult, aged 18 to 74 years old.
Must have a condition called cutaneous sarcoidosis that affects the face. This is diagnosed by a specific appearance of the skin and confirmed by a skin biopsy, which is a small sample of skin taken for testing.
The condition must be moderate to severe, as measured by specific medical scales: SASI (Sarcoidosis Area and Severity Index) facial score of 2 or more, and PGA (Physician's Global Assessment) of skin 5 or more on a scale of 1 to 10.
Must be a member of a French health insurance scheme.
Must have tried at least one standard treatment for the condition without success, or have never tried systemic treatment, which means treatment that affects the whole body.
Women who can have children must have a negative pregnancy test and use effective birth control, like a contraceptive pill or intrauterine device, during the study and for 12 weeks after stopping the study medication.
Must provide written consent to participate in the study.

Who cannot join the trial?

4 criteria

Patients who are under 18 years old cannot participate.
Patients who do not have cutaneous sarcoidosis on their face cannot participate. Cutaneous sarcoidosis is a condition where small lumps form on the skin, in this case, on the face.
Patients who are not adults, meaning they are younger than 18, cannot participate.
Patients who are not able to give their own consent to participate cannot join the study.

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Hopital Beaujon
Clichy, France

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Investigated drugs

Sirolimus is a medication being studied for its effectiveness in treating facial skin involvement in sarcoidosis. Sarcoidosis is a condition that causes small patches of red and swollen tissue, called granulomas, to develop in the organs of the body, including the skin. Sirolimus is taken orally and is being tested to see if it can help reduce the severity of skin symptoms in patients with moderate to severe cases.

Sirolimus

What is already known about the treatment

Sirolimus – Sirolimus is administered orally and is currently being studied for its effectiveness in treating cutaneous sarcoidosis, particularly involving the face in adults. It is well-documented in medical literature as an immunosuppressant, primarily used to prevent organ transplant rejection. The main therapeutic indication in this trial is for adult patients with moderate to severe facial skin involvement due to sarcoidosis. At the molecular level, sirolimus works by inhibiting a protein called mTOR, which plays a crucial role in cell growth and proliferation. It is classified pharmacologically as an mTOR inhibitor.

Investigated diseases

Sarcoidosis – Sarcoidosis is an inflammatory disease characterized by the formation of tiny clumps of inflammatory cells, known as granulomas, in various organs of the body. When it affects the skin, it can cause rashes, bumps, or discolored patches, often appearing on the face. The disease can progress with periods of improvement and worsening, and the skin involvement may vary in severity. Over time, the granulomas can lead to scarring and changes in skin texture. The exact cause of sarcoidosis is unknown, but it is believed to involve an abnormal immune response. It can affect people of any age, but it is most commonly diagnosed in adults.