Definition

A topical gel formulation, with potential immunomodulatory activity that can potentially be used for treatment of epidermal growth factor receptor (EGFR) inhibitor (EGFRI)-induced skin toxicity. Upon application of the topical gel HT-001 to the affected area(s) of the skin, scalp and nails, HT-001 is able to inhibit the recruitment and activation of immune cells and inhibit the expression of inflammatory mediators that are induced by EGFR signaling blockade resulting from EGFRI cancer therapy. This may prevent or reduce inflammation, reduce substance P and reduce neutrophil activity, thereby preventing and/or clearing the rash and the associated itching and/or hair loss induced by EGFRI therapy. EGFR signaling is critical to maintain normal, healthy skin homeostasis. EGFR inhibition results in high influx of inflammatory cells and production of pro-inflammatory cytokines in the skin. EGFR signaling blockade increases C-C motif chemokine ligand 2 (CCL2) and 5 (CCL5) expression.