In short
Currently, there is one active clinical trial investigating new treatment options for cutaneous sarcoidosis affecting the face. This trial is evaluating the use of Sirolimus, an immunosuppressant medication, in adults with moderate to severe facial skin involvement. The study is being conducted in France and aims to assess whether this treatment can significantly improve skin symptoms and quality of life for patients living with this challenging condition.
Clinical trial locations
Study on Sirolimus for Adults with Facial Skin Sarcoidosis: Evaluating Treatment for Moderate to Severe Cases
This clinical trial is investigating whether Sirolimus can effectively treat moderate to severe facial skin involvement in people with sarcoidosis. Sarcoidosis causes small clusters of inflammatory cells, called granulomas, to form in different parts of the body. When these affect the facial skin, they can cause visible rashes, bumps, or discolored patches that may impact a person's quality of life.
Who can participate:
- Adults aged between 18 and 74 years
- People with confirmed cutaneous sarcoidosis affecting the face, diagnosed through skin appearance and confirmed by a skin biopsy
- Those with moderate to severe condition, measured by specific scales: a SASI facial score of 2 or more and a Physician's Global Assessment score of 5 or more on a scale of 1 to 10
- Patients who have tried at least one standard treatment without success, or who have never tried systemic treatment
- Members of a French health insurance scheme
- Women of childbearing age must use effective birth control during the study and for 12 weeks after treatment ends, and have a negative pregnancy test
Who cannot participate:
- People under 18 years of age
- Those without cutaneous sarcoidosis affecting the face
- Individuals unable to provide their own informed consent
What the trial involves:
The study focuses on evaluating how well Sirolimus works in reducing facial skin symptoms over a 16-week treatment period. Participants will take Sirolimus as an oral tablet. Throughout the study, researchers will monitor changes in skin appearance using standardized assessment tools and photographs. They will also track any side effects, such as mouth ulcers or changes in blood cell counts.
The main goal is to determine whether Sirolimus can produce a significant clinical response, defined as at least a 25% reduction in the facial skin severity score. Secondary goals include assessing complete improvement of symptoms, changes in quality of life related to skin appearance, and overall safety of the treatment.
The investigational drug:
Sirolimus is an immunosuppressant medication that is commonly used to prevent organ transplant rejection. In this trial, it is being studied for a new use: treating facial skin involvement in sarcoidosis. The medication works by inhibiting a protein called mTOR, which plays an important role in cell growth and the immune response. By blocking this protein, Sirolimus may help reduce the inflammatory processes that cause skin symptoms in sarcoidosis.
Summary
Currently, only one clinical trial is actively recruiting patients with cutaneous sarcoidosis affecting the face. This trial is taking place in France and is specifically focused on adults with moderate to severe facial involvement who have not responded well to standard treatments. The study is investigating Sirolimus, a medication that works by suppressing the immune system, as a potential treatment option.
The trial represents an important step in finding better treatment options for people whose facial skin is affected by sarcoidosis, particularly those who have exhausted other treatment possibilities. The 16-week study period will provide valuable information about both the effectiveness and safety of this approach. Patients interested in participating must meet specific eligibility criteria and be able to commit to regular monitoring throughout the treatment period.
