Novel Topical Therapy Offers New Path Forward for Oncology-Related Dermatologic Care

Hoth Therapeutics has reported positive interim results from its ongoing phase 2 HT-001 program, announcing that the investigational topical agent met its primary efficacy endpoint in patients experiencing dermatologic toxicities associated with epidermal growth factor receptor (EGFR) inhibitor therapy. The interim analysis showed that treated patients achieved an ARIGA rash severity score of ≤1 by week 6 — a clinically meaningful threshold reflecting near-complete or complete rash resolution.¹

Background and Clinical Context

EGFR-associated acneiform rash is among the most common and treatment-limiting dermatologic adverse events encountered in oncologic practice. Affecting a substantial proportion of patients receiving agents such as erlotinib, cetuximab, and osimertinib, the rash can range from mild papulopustular eruption to severe, disfiguring involvement that compromises tolerability and adherence. In current practice, management typically involves topical or systemic antibiotics, corticosteroids, and moisturizers — an approach that is largely empirical and inconsistently effective. When toxicity becomes severe, oncologists may reduce doses or discontinue EGFR therapy altogether, with potential consequences for tumor control.²

The need for a validated, targeted intervention that reliably controls cutaneous toxicity without undermining the cancer regimen has remained unmet.

Interim Efficacy Results

The primary endpoint — an ARIGA score of ≤1 at week 6 — was achieved in the interim cohort, suggesting meaningful rash resolution within the treatment window. The ARIGA (Assessment of Rash In Genetic and Anti-cancer treatments) scale is a standardized instrument for grading acneiform toxicity severity, and a score at or below 1 corresponds to minimal or absent clinical findings.

Beyond the primary endpoint, patient-reported outcomes reinforced the efficacy signal. More than 65% of patients reported meaningful reductions in both pain and pruritus — symptoms that significantly affect quality of life and daily functioning in this population, and that are often inadequately addressed by standard supportive measures.

Critically, no patients in the cohort required dose reduction or discontinuation of their EGFR during the treatment period. For dermatologists and oncologists managing these patients collaboratively, this finding carries considerable weight: it suggests HT-001 may enable patients to remain on full therapeutic doses of their cancer treatment while dermatologic toxicity is actively controlled.

Safety and Pharmacokinetic Profile

HT-001 was well tolerated across the interim cohort, with no treatment discontinuations reported. Pharmacokinetic analysis revealed systemic exposure approximately 99% lower than that associated with FDA-approved oral comparators used in this setting. This near-absence of systemic absorption positions HT-001 as a locally acting agent — a profile that may be particularly advantageous in oncology-adjacent applications, where patients often carry a high systemic medication burden and where minimizing drug–drug interactions or cumulative toxicity is a priority.

Program Expansion

Building on the interim results, Hoth Therapeutics is actively expanding the geographic footprint of the phase 2 trial. The company has received regulatory approval from Hungarian authorities to enroll patients at a clinical site in Hungary — marking HT-001's first approved presence in Europe. Additional regulatory submissions are pending in Spain and Poland, where site activations are anticipated in the near term. In the United States, at least 1 additional clinical site is planned for activation alongside the existing enrollment infrastructure, with the goal of accelerating patient accrual and broadening the dataset ahead of a full analysis.

Clinical Implications

For dermatologists embedded in oncology care — or those managing referrals from oncology practices — EGFR-associated rash represents a recurring and often difficult consultation. Current interventions can attenuate symptoms but rarely resolve them fully, and few have been evaluated with the rigor of a controlled trial using standardized severity instruments.

The interim HT-001 data, while preliminary, offers a potentially differentiated profile: primary endpoint achievement, patient-reported symptom relief across the two most burdensome symptoms, preserved oncologic therapy continuity, and a favorable systemic safety margin. Whether these results hold in a fully powered analysis and across the expanded international cohort will determine the therapy's broader clinical positioning.

Reference

1. Hungary approves trial expansion as HT-001 meets primary endpoint in interim analysis with patients reaching ARIGA ≤1 by week six. News release. Hoth Therapeutics. Published April 1, 2026. Accessed April 1, 2026. https://www.prnewswire.com/news-releases/hungary-approves-trial-expansion-as-ht-001-meets-primary-endpoint-in-interim-analysis-with-patients-reaching-ariga-1-by-week-six-302731156.html
2. Fabbrocini G, Panariello L, Caro G, Cacciapuoti S. Acneiform rash induced by EGFR inhibitors: review of the literature and new insights. Skin Appendage Disord. 2015;1(1):31-37. doi:10.1159/000371821