RecruitingPhase 2NCT05639933

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

A Randomized, Placebo-controlled, Parallel Phase 2a Dose-ranging 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


Sponsor

Hoth Therapeutics, Inc.

Enrollment

152 participants

Start Date

Jul 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a topical (applied to the skin) treatment called HT-001 for the painful and disfiguring rash that is a common side effect of cancer drugs called EGFR inhibitors (EGFRIs). EGFRIs are used to treat cancers like lung, colorectal, and head-and-neck cancer, but the rash they cause can be so bothersome that patients sometimes need to reduce or stop their cancer treatment. You may be eligible if... - You are 18 or older and are taking an approved EGFR inhibitor for cancer - You have developed a rash or skin reaction (pustules, papules, or burning) as a side effect of the EGFRI - Your rash is grade 3 or below and affects no more than 30% of your body surface - Your ECOG performance status is 0–2 - Your expected life expectancy is at least 3 months You may NOT be eligible if... - Your rash is severe (grade 4) or affects more than 30% of your body - You have a history of eczema, psoriasis, or other chronic skin conditions - You are receiving radiation to the head, neck, or upper chest at the same time as EGFRI therapy - You are pregnant or breastfeeding - You have a known allergy to aprepitant or any component of HT-001 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHT-001 2% Topical Gel

Topical gel, 2% active

DRUGHT-001 1% Topical Gel

Topical gel, 1% active

DRUGHT-001 0.5% Topical Gel

Topical gel, 0.5% active

DRUGHT-001 Placebo

Topical gel, vehicle gel


Locations(12)

UCI Health - CIACC

Irvine, California, United States

UC Irvine - Chao Family Cancer Center

Orange, California, United States

Regis Clinical Research

Miami, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

NYU Langone Health

Mineola, New York, United States

Northwell Physician Partners Dermatology

New Hyde Park, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Gabrail Cancer & Research Center

Canton, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

Centrum Medyczne Pratia Krakow

Krakow, Poland

NZOZ Neuromed M. i M. Nastaj Sp.P

Lublin, Poland

Hospital Sant Joan de Deu-Fundacio Althaia

Manresa, Spain

View Full Details on ClinicalTrials.gov

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NCT05639933


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