Actively Recruiting
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
Led by Hoth Therapeutics, Inc. · Updated on 2026-03-31
152
Participants Needed
12
Research Sites
180 weeks
Total Duration
On this page
Sponsors
H
Hoth Therapeutics, Inc.
Lead Sponsor
I
ICON Clinical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participant (18 years or older) prescribed an approved EGFR inhibitor to treat cancer
- Developed a rash or skin symptoms related to EGFR inhibitor therapy with severity 3 or less and affecting 30% or less of body surface area
- ECOG performance status of 0 to 2
- Predicted life expectancy of at least 3 months
- Able and willing to comply with contraceptive requirements
- Able and willing to attend all required study visits (telehealth and in person)
- Willing and able to provide written informed consent
You will not qualify if you...
- Severe cutaneous toxicity (severity 4) or involvement greater than 30% body surface area due to EGFR inhibitor therapy
- Severe systemic toxicity (severity greater than 3) from EGFR inhibitor therapy
- Medical conditions that may prevent compliance or study completion
- History of other skin disorders that could affect study results or pose risk
- Abnormal laboratory values at screening including low neutrophil, white blood cell, or platelet counts, or elevated liver enzymes, bilirubin, or creatinine
- Known history of QT interval prolongation
- Radiation treatment to head, neck, or upper trunk concurrent with EGFR inhibitor therapy or within 4 weeks prior to screening
- Use of aprepitant or other neurokinin-1 receptor antagonists within 4 weeks prior to screening
- Prior investigational drug treatment within 4 weeks or 8 half-lives before screening
- Active infection or uncontrolled disease except cancer
- Recent changes in topical or systemic antibiotics or steroid treatments within 14 days prior to screening, except stable doses
- Use of certain medications affecting CYP3A4 enzymes within 30 days prior to screening
- Known hypersensitivity to aprepitant or any component of HT-001
- Pregnant or breastfeeding, or planning pregnancy during the study including follow-up period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
UCI Health - CIACC
Irvine, California, United States, 92612
Actively Recruiting
2
UC Irvine - Chao Family Cancer Center
Orange, California, United States, 92868
Actively Recruiting
3
Regis Clinical Research
Miami, Florida, United States, 33126
Actively Recruiting
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
NYU Langone Health
Mineola, New York, United States, 11501
Actively Recruiting
6
Northwell Physician Partners Dermatology
New Hyde Park, New York, United States, 11042
Actively Recruiting
7
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
8
Gabrail Cancer & Research Center
Canton, Ohio, United States, 44718
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
Centrum Medyczne Pratia Krakow
Krakow, Poland, 30-727
Active, Not Recruiting
11
NZOZ Neuromed M. i M. Nastaj Sp.P
Lublin, Poland, 20-064
Active, Not Recruiting
12
Hospital Sant Joan de Deu-Fundacio Althaia
Manresa, Spain, 8243
Active, Not Recruiting
Research Team
H
Hayley Springer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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