Hoth Therapeutics, a patient-focused biopharmaceutical company, 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 the severity of rash, pain, and itching (pruritus), 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.
"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," stated Hoth Therapeutics Chief Executive Officer, Robb Knie.
More information on the trial can be found at clinicaltrials.gov.
About Hoth Therapeutics, Inc.
Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to develop innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://ir.hoththerapeutics.com/
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special
offers from Pharmaceutical Outsourcing – all delivered right to your inbox! Sign up now!