MedTrace Logo

Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors

NCT05639933 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2026-03-31

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about HT-001 Topical Gel for treatment of EGFR inhibitor-induced skin toxicities. The main questions it aims to answer are:

* Determine the therapeutic effect of HT-001 for treatment of patients who develop acneiform rash undergoing Epidermal Growth Factor inhibitor (EGFRI) therapy using the acneiform rash investigator's global assessment scale \[ARIGA\]
* Evaluate the safety of HT-001 during treatment

Participants will apply HT-001 Gel once per day for 6 weeks, during which the effect on treating acneiform rash or other skin disorders induced by EGFRI therapy will be evaluated using different assessment tools to measure severity of rash, pain, and itching (pruritus), as well as the change in quality of life.

The study will be completed in 2 periods: the first period is open-label (unblinded) and all patients will receive HT-001 topical gel with the active ingredient; the second period is blinded and patients will be randomized to receive one of three concentrations of HT-001 or placebo.

Researchers will compare HT-001 to the placebo in the second period to see if HT-001 provides a significant treatment effect.

Conditions

  • Acneiform Eruption Due to Chemical
  • Xerosis Cutis
  • Paronychia

Interventions

DRUG

HT-001 2% Topical Gel

Topical gel, 2% active

DRUG

HT-001 1% Topical Gel

Topical gel, 1% active

DRUG

HT-001 0.5% Topical Gel

Topical gel, 0.5% active

DRUG

HT-001 Placebo

Topical gel, vehicle gel

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • Hoth Therapeutics, Inc.

    lead OTHER

Principal Investigators

  • Mario Lacouture, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-19
Primary Completion
2026-12-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States
  • Poland
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05639933 on ClinicalTrials.gov