Novel topical formulation of Cyclosporine

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Patient outcome: Left- 79-year-old patient after 3.5 months. Right- 50-year-old patient after 4 weeks of treatment with the novel formulation. Ref: JAAD Case Rep. 2023 Aug 20;40

Invention Summary:

Pyoderma Gangrenosum (PG) is a rare, acute inflammatory skin disorder characterized by the rapid development of large, painful ulcers. PG frequently co-occurs with systemic conditions such as inflammatory bowel disease, arthritis, and hematological disorders. Current therapeutic interventions focus on inflammation reduction, pain management, wound closure, and addressing underlying systemic diseases.

Rutgers researchers have tested this innovation in seven cases. This innovation centers on a novel topical formulation of cyclosporine A (CsA) incorporated in Vitamin E oil (VE), designed as a complementary treatment PG.  By directly targeting the skin surface, the formulation modulates the local immune response while minimizing systemic side effects typically associated with oral or intravenous delivery. The oil-based formulation ensures complete wound bed adhesion. The incorporation of VE enhances lipophilicity for optimal absorption. A case series demonstrated significant pain reduction in six of seven patients within four weeks of topical CsA treatment, with initial improvements reported as early as ten days.

Market Applications:

• A novel therapeutic approach for chronic, recalcitrant skin ulcers, addressing a significant unmet medical need.
• Potential applications extend beyond ulcerative skin conditions, across dermatology, wound care, and autoimmune disease management, including psoriasis, atopic dermatitis, alopecia, folliculitis decalvans, dissecting cellulitis, and hidradenitis suppurativa.

Advantages:

• Localized application to affected areas optimizes therapeutic efficacy.
• Minimized systemic absorption compared to oral or injectable alternatives lowers the risk of side effects.
• Convenient home application enhances treatment adherence.
• Efficacy Across Disease Spectrum, managing mild to moderate cases of PG

Intellectual Property & Development Status: