On February 24, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH) reported a significant expansion of its CLEER-001 Phase 2a clinical trial with the addition of Regis Clinical Research as a new enrolling site. Located in Miami, Florida, Regis joins the growing CLEER-001 investigational site network as surging patient demand outpaces capacity at existing sites — a direct reflection of the compelling early clinical results HT-001 has produced and the desperate unmet need it addresses.
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For the estimated 200,000 Americans who begin EGFR Inhibitor cancer therapy each year, the skin toxicities that accompany treatment are not a minor inconvenience. They are severe, often disfiguring rashes, lesions, and unrelenting itch that force up to one-third of patients to reduce or discontinue the chemotherapy keeping them alive. Today, those patients have no FDA-approved treatment option. HT-001 is designed to change that — and the data so far suggests it can.
Positive Signal
The interim CLEER-001 data is generating physician and patient interest that drives enrollment expansions like today’s announcement:
100% of open-label cohort patients achieved the primary efficacy endpoint — an ARIGA rash severity score of ≤1 — by week six
Zero patients required dose reduction or discontinuation of their life-saving EGFRi cancer therapy while on HT-001
Over 65% of patients reported meaningful reductions in pain and itching
Zero dose-limiting toxicities observed across the entire trial to date
At the American Academy of Dermatology Annual Meeting, a case study demonstrated complete lesion and symptom resolution after just one week of twice-daily application in a metastatic breast cancer patient
For a patient population that currently has no targeted treatment, results like these represent a potential paradigm shift in how oncologists can manage one of the most common and quality-of-life-destroying side effects in all of cancer care.
A New Site, A New Market, A Growing Network
Regis Clinical Research brings IRB-approved, FDA-compliant research infrastructure and a new South Florida patient population to the CLEER-001 network. For Hoth, it means faster enrollment, a faster path to a complete data set, and a faster road to the regulatory milestones that matter.
"The addition of Regis Clinical Research is a direct response to the acceleration we are seeing in enrollment demand," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "The data speaks for itself. Patients and oncologists are taking notice — and we are building the infrastructure to meet that demand and deliver the full clinical readout this program deserves."
Patients and referring physicians may visit regisclinical.com or call +1 (305) 546-3952 to learn more about participation in the CLEER-001 trial.
(Press release, Hoth Therapeutics, FEB 24, 2026, View Source [SID1234662945])