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Clinical trialNCT05639933RecruitingPhase 2Interventional

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

SponsorHoth Therapeutics, Inc.Enrollment152Acneiform Eruption Due to ChemicalParonychiaXerosis Cutis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Poland
  • Centrum Medyczne Pratia Krakow

    Krakow, Poland

    Active, not recruiting
  • Nzoz Neuromed M. I M. Nastaj Sp.P

    Lublin, Poland

    Active, not recruiting
Spain
  • Hospital Sant Joan de Deu-Fundacio Althaia

    Manresa, Spain

    Active, not recruiting
United States
  • Uci Health - Ciacc

    Irvine, California, United States

    Janellen Smith, MD
    Recruiting
  • Uc Irvine - Chao Family Cancer Center

    Orange, California, United States

    Janellen Smith, MD
    Recruiting
  • Regis Clinical Research

    Miami, Florida, United States

    Yilena Rodriguez, MD
    Recruiting
  • Dana Farber Cancer Institute

    Boston, Massachusetts, United States

    Connie Shi, MD
    Recruiting
  • Nyu Langone Health

    Mineola, New York, United States

    Recruiting
  • Northwell Physician Partners Dermatology

    New Hyde Park, New York, United States

    Sheila Shaigany, MD
    Recruiting
  • Montefiore Medical Center

    The Bronx, New York, United States

    Beth McLellan, MD
    Recruiting
  • Gabrail Cancer & Research Center

    Canton, Ohio, United States

    Nashat Gabrail, MD
    Recruiting
  • Md Anderson Cancer Center

    Houston, Texas, United States

    Anisha Patel, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

HT-001 0.5% Topical GelHT-001 1% Topical GelHT-001 2% Topical GelHT-001 Placebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
19 Jul 2023
Primary completion
30 Dec 2026
Completion
30 Dec 2026
Last update posted
31 Mar 2026
Registered enrollment
152
Registry id
NCT05639933

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.