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New treatment option for Alopecia Areata
Official title Intralesional Cyclosporine for Alopecia Areata
ClinicalTrials.gov ID: NCT07029204
What this study is testing
What is CycloSPORINE Injectable Product?
CycloSPORINE Injectable Product is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for alopecia areata.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Alopecia areata (AA) is a chronic autoimmune disease that causes non-scarring, focal areas of hair loss. Due to its resulting disfigurement and unpredictable course, it is recognized as a serious medical condition with severe emotional and psychosocial distress, including a high prevalence of depression and anxiety.1-4 Treatment options for alopecia areata are limited.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age between 18 and 65 at screening visit.
- Diagnosis of alopecia areata by a board-certified dermatologist at screening visit.
- Current alopecia areata episode involving the scalp of more than 3 months' duration prior to baseline visit.
- SALT Score between 10 and 50 at baseline visit.
- Stable disease based on subject history over the past 1 month.
You likely can't join if
- Currently experiencing other forms of alopecia. Including but not limited to: androgenetic alopecia, telogen effluvium, or any other concomitant...
- Previous treatment with cyclosporine
- Other autoimmune diseases
- Pregnancy or lactation
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric...
- Adults unable to consent
See the full eligibility criteria
- Age between 18 and 65 at screening visit.
- Diagnosis of alopecia areata by a board-certified dermatologist at screening visit.
- Current alopecia areata episode involving the scalp of more than 3 months' duration prior to baseline visit.
- SALT Score between 10 and 50 at baseline visit.
- Stable disease based on subject history over the past 1 month.
- Agree not to use any alopecia areata treatments during the study, including, but not limited to: systemic therapies (eg, methotrexate, cyclosporine, corticosteroids, JAK inhibitors) and biologics (eg, monoclonal...
- Currently experiencing other forms of alopecia. Including but not limited to: androgenetic alopecia, telogen effluvium, or any other concomitant conditions (eg, tinea capitis, psoriasis, lupus erythematosus, or...
- Previous treatment with cyclosporine
- Other autoimmune diseases
- Pregnancy or lactation
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the...
- Adults unable to consent
- Prisoners
- Currently using drugs that are well-substantiated to interact with cyclosporine, including the following: ciprofloxacin, gentamicin, tobramycin, trimethoprim with sulfamethaxazole, vancomycin, melphalan, amphotericin B...
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.