Erlotinib ointment 3.5% and 5% were investigated by Sol-Gel on healthy volunteers in maximal use condition. Following 28 days of daily application all 12 subjects have completed the study. In general both Erlotinib ointment 3.5% and 5% are considered to be well tolerated , no systemic absorption-related adverse events were reported.
The following background information was taken from Sol-Gel’s website:
“SGT-210 (erlotinib) is a topical drug candidate for the treatment of pachyonychia congenita and other hyperkeratosis indications. Erlotinib is a tyrosine kinase receptor inhibitor which acts on the epidermal growth factor receptor, a protein expressed on the surface of cells, whose job is to help cells grow and divide. There is a case report showing that orally administered erlotinib improved the quality of life of pachyonychia congenita patients but was associated with significant adverse events, while topically applied erlotinib, 0.2%, failed to display significant improvement1. Sol-Gel’s scientists have managed to overcome erlotinib formulation limitations and developed a topical product with a significantly higher concentration of erlotinib than that which was reported to be inefficient. SGT-210 is expected to treat pachyonychia congenita without the adverse events caused by oral erlotinib. Our Phase-1 was initiated in December 2022.
1 Céline Greco, Anne-Charlotte Ponsen, Stéphanie Leclerc-Mercier, Joël Schlatter, Salvatore Cisternino, Claude Boucheix, Christine Bodemer. Treatment of Painful Palmoplantar Keratoderma Related to Pachyonychia Congenita Using EGFR Inhibitors. 2022 Apr 3;10(4):841. DOI: 10.3390/biomedicines10040841″