NCT05639933 · Hoth Therapeutics, Inc.
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
(CLEER)
What this study is about
The goal of this clinical trial is to learn about HT-001 Topical Gel for treatment of EGFR inhibitor-induced skin toxicities.
View original scientific description
The goal of this clinical trial is to learn about HT-001 Topical Gel for treatment of EGFR inhibitor-induced skin toxicities.
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
Primary outcome measures
Acneiform Rash Investigator's Global Assessment Scale [ARIGA ]
Time frame: 6 weeks
Proportion of patients with a grade ≤ 1 based on the Acneiform Rash Investigator's Global Assessment \[ARIGA\] Scale; novel 5-point scale 0-4 with score of 0 is clear and grade 4 being most severe
Pharmacokinetics of HT-001 applied topically [Cohort 1] - Area Under the Curve (AUC)
Time frame: Day 1 and Day 42
Characterize pharmacokinetics of HT-001 parameters including: measured drug concentrations above the lower limit of quantitation, number of patients with measurable systemic exposure; if data allow - area under the curve (AUC)
Pharmacokinetics of HT-001 applied topically [Cohort 1] - Peak Plasma Concentration (Cmax)
Time frame: Day 1 and Day 42
Characterize pharmacokinetics of HT-001 parameters including: maximum (or peak) serum concentration (Cmax)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult patient (ie, ≥ 18 years of age at Screening/Baseline \[V1\]) prescribed an approved EGFRI to treat cancer (indication within the approved labeling for the EGFRI). 2. Patient has developed a rash or symptoms of a rash (papular and/or pustular eruptions) or symptoms of a rash (cutaneous burning), as assessed by both Common Terminology Criteria for Adverse Events (CTCAE) grading and ARIGA scales (severity ≤ 3) with overall involvement ≤ 30% BSA. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 4. Predicted life expectancy ≥ 3 months. 5. Patient is able and willing to comply with contraceptive requirements. 6. Patient must have the ability and willingness to attend the necessary visits (telehealth and in person). 7. Patient must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
Exclusion criteria
- Patient has severe c
Where
- Irvine, California
- Orange, California
- Miami, Florida
- Boston, Massachusetts
- Mineola, New York
- New Hyde Park, New York
- The Bronx, New York
- Canton, Ohio
- Houston, Texas
Collaborators
ICON Clinical Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 31, 2026 · Source of record for eligibility and locations