Hoth Therapeutics receives approval from FDA for protocol change in HT-001 trial

Hoth Therapeutics announced that it has received approval from the FDA for a protocol change in its Phase 2a clinical trial of HT-001. Participants will apply HT-001 Gel once per day for 6 weeks, during which the effect on treating acneiform rash and other skin disorders induced by EGFRI therapy will be evaluated using different assessment tools to measure severity of rash, pain, and itching, as well as the change in quality of life. The study will be completed in 2 parts: the first part is an open-label (unblinded) 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.