- Topical mTOR-I may be effective in treating numerous cutaneous vascular and proliferative conditions
- Potential to improve many rare and unmet dermatologic conditions for patients
- Addresses unmet needs in dermatology, providing a novel approach to treating challenging skin conditions
OVERVIEW
Methods for treating various cutaneous vascular and proliferative conditions using topical mammalian target of rapamycin (mTOR) inhibitors, such as sirolimus (rapamycin) and everolimus, are disclosed. Treatable conditions include venolymphatic malformations, acne, scars, and malignancies associated with PI3K/AKT/mTOR mutations. Georgetown University Medical Center's Department of Dermatology has successfully treated conditions like Non-Langerhans Cell Histiocytosis, Venolymphatic Malformation, and Capillary Malformation-Arteriovenous Malformation using compounded topical rapamycin. Topical application minimizes systemic absorption, avoiding adverse effects and offering potential as an antiproliferative medication for various skin disorders.
BACKGROUND
Rapamycin is a known mTOR inhibitor and is approved orally for systemic use in various clinical applications. However, there is no standard or commercially available topical formulation in the U.S. Topical mTOR inhibitors have shown tremendous promise in treating several dermatological conditions for which there are currently no other treatments.
Benefit
● Offers a unique and effective treatment for various skin conditions without current therapeutic options.
● Minimizes systemic absorption, reducing the risk of adverse effects and making it a safer option.
● Addresses a wide range of dermatological conditions, providing a versatile solution for different patient needs.
● Potential for improved patient outcomes with a topical application that is less invasive and more convenient.
● Despite the high cost of oral rapamycin, the topical formulation presents a cost-effective alternative for patients.
Market Application
● Targeting dermatological conditions with limited treatment options, the invention serves patients with non-Langerhans cell histiocytosis, venolymphatic malformations, and other skin disorders.
● Widely applicable in general dermatology, offering a new tool for treating common conditions like acne and rosacea.
● Addresses cutaneous malignancies and tumors associated with PI3K/AKT/mTOR mutations, offering a potential alternative or complementary approach to existing treatments.
● Provides a valuable option for pediatric patients with conditions such as RASopathies and PIK3CA-related overgrowth spectrum (PROS).
● Useful in managing scars, hypertrophic or keloidal scars, and other proliferative conditions encountered in plastic surgery procedures.
Publications
● DeKlotz CM, Ogram AE, Singh S, Dronavalli S, MacGregor JL. Dramatic improvement of facial angiofibromas in tuberous sclerosis with topical rapamycin: optimizing a treatment protocol. Arch Dermatol 2011 Sep;147(9):1116‐7.
● U.S. Provisional Patent Application No. 62/626,779
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