HT-001 is being studied for the treatment of mild to moderate cutaneous toxicities associated with EGFR inhibitor cancer therapy.

Hoth Therapeutics, Inc. received approval from the Food & Drug Administration (FDA) for a protocol change in its Phase 2a clinical trial of HT-001. 

Participants will apply HT-001 Gel once per day for six weeks, during which the effect on treating acneiform rash and other skin disorders induced by epidermal growth factor receptor inhibitors will be evaluated using different assessment tools to measure severity of rash, pain, and pruritus, as well as the change in quality of life.

The study will be completed in two parts: the first part is an open-label cohort and all patients will receive HT-001 topical gel with the active ingredient; the second part is a randomized, placebo-controlled, parallel Phase 2a dose-ranging study and patients will be randomized to receive one of three concentrations of HT-001 or placebo. Hoth will compare HT-001 to the placebo in the second period to see if HT-001 provides a significant treatment effect.

"With our recent change in protocol approved, we believe that HT-001 for the treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors will be more widely available for patients suffering from chemo rash," says Hoth Therapeutics Chief Executive Officer, Robb Knie, in a news release.