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
NCT ID: NCT05639933
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
152 participants
INTERVENTIONAL
2023-07-19
2026-12-30
Brief Summary
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* 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.
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Detailed Description
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The study will be conducted in 2 periods: Part 1, an open-label cohort consisting of 12 patients to measure pharmacokinetics of HT 001 gel followed by Part 2, a randomized, parallel arm study comparing 3 dose strengths of HT-001 gel to placebo (HT 001 vehicle). Patients in the randomized cohorts will be randomly assigned to 1 of the 4 treatment arms in a 2:2:2:1 ratio (active groups = 2: placebo = 1).
All patients in both open-label and blinded cohorts will apply the study drug once a day to each area affected with cutaneous toxicity up to 30% body surface area (BSA) involvement, inclusive of skin, scalp, and nails.
The goal of the study is to determine the minimum efficacious dose strength(s) for further investigation. The dose effect, together with the application site safety assessments, and therapeutic effects based on the primary and secondary endpoints will be evaluated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Open-Label PK Cohort
Topical treatment with HT-001 2% Gel unblinded.
HT-001 2% Topical Gel
Topical gel, 2% active
Randomized, Double Blind Cohort
Topical treatment with HT-001 (2%, 1%, or 0.5%) or placebo (HT-001 vehicle), blinded
HT-001 2% Topical Gel
Topical gel, 2% active
HT-001 1% Topical Gel
Topical gel, 1% active
HT-001 0.5% Topical Gel
Topical gel, 0.5% active
HT-001 Placebo
Topical gel, vehicle gel
Interventions
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HT-001 2% Topical Gel
Topical gel, 2% active
HT-001 1% Topical Gel
Topical gel, 1% active
HT-001 0.5% Topical Gel
Topical gel, 0.5% active
HT-001 Placebo
Topical gel, vehicle gel
Eligibility Criteria
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Inclusion Criteria
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
2. Patient has any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the patient would comply with the protocol or complete the study per protocol.
3. Patient has a history of other skin disorders (eg, atopic dermatitis, psoriasis, recurrent skin infections), or history of illness that, in the opinion of the Investigator, would confound results of the study or pose unwarranted risk in administering study drug to the patient.
4. Patient has abnormal laboratory values at Screening/Baseline (V1):
1. Absolute neutrophil count \< 1000/mm3 and WBC count \< 3000/mm3
2. Platelet count \< 50,000/mm3
3. Aspartate transaminase (AST) \> 2.5 × upper limit of normal (ULN)
4. Alanine transaminase (ALT) \> 2.5 × ULN
5. Bilirubin \> 1.5 × ULN
6. Creatinine \> 1.5 × ULN
5. Patient has a prescribed cancer treatment plan that requires radiation treatment to the head, neck, or upper trunk concurrent with EGFRI therapy or has previously received radiation therapy within 4 weeks prior to Screening/Baseline (V1).
6. Patient has received aprepitant or other neurokinin-1 receptor antagonist within 4 weeks prior to Screening/Baseline (V1).
7. Patient has had prior treatment with an investigational drug within 4 weeks prior to Screening/Baseline (V1), or at least 8 half-lives of the drug, whichever is longer.
8. Patient has an active infection (eg, pneumonia) or any uncontrolled disease except for the malignancy that, in the opinion of the Investigator, might confound the result or the study or pose unwarranted risk in administering the study drug to the patient.
9. Patient has received non-stable escalating doses of topical antibiotics, topical steroids, or other topical treatments within 14 days prior to Screening/Baseline (V1). Patients who have been on stable doses of topical antibiotics, topical steroids, or other topical treatments for 14 days or more are allowed to be enrolled and to stay on their current prescription. Reduction in dose due to improvement in EGFRI-related toxicities is allowed.
10. Patient has used non-stable escalating doses of systemic steroids within 14 days prior to Screening/Baseline (V1) excluding low-dose systemic corticosteroids as part of standard of care for prevention or treatment of chemotherapy-induced nausea and vomiting; acceptability of the steroid and dose is to be determined by the study Investigator. Patients who have been on a stable dose of systemic steroids for 14 days or more are allowed to be enrolled and to stay on their current prescription. Reduction in dose due to improvement in EGFRI-related toxicities is allowed. Use of steroid inhalers and nasal corticosteroids is allowed.
11. Patient has received non-stable escalating dose treatment with a systemic antibiotic within 14 days prior to Screening/Baseline (V1). Patients who have been on stable doses of systemic antibiotics for 14 days or more are allowed to be enrolled and to stay on their current prescription. Reduction in dose due to improvement in EGFRI-related toxicities is allowed.
12. Patient has received concomitant treatment with pimozide, moderate to strong cytochrome p450 (CYP) 3A4 inhibitors (diltiazem, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir), or strong CYP3A4 inducers (rifampin, carbamazepine, phenytoin) within 30 days of Screening/Baseline (V1).
13. Patient has a history of hypersensitivity to aprepitant or any component of HT-001.
14. Patient is pregnant or lactating at Screening/Baseline (V1) or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
18 Years
ALL
No
Sponsors
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ICON Clinical Research
INDUSTRY
Hoth Therapeutics, Inc.
OTHER
Responsible Party
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Principal Investigators
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Mario Lacouture, MD
Role: STUDY_CHAIR
NYU Langone Health
Locations
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UCI Health - CIACC
Irvine, California, United States
UC Irvine - Chao Family Cancer Center
Orange, California, United States
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 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
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Bao-An Huynh
Role: primary
Study Coordinator
Role: primary
Harita Dharaneeswaran
Role: primary
Shirly Gholian
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Stacie Stutt
Role: primary
References
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Guenther L, Lynde CW, Andriessen A, Barankin B, Goldstein E, Skotnicki SP, Gupta SN, Choi KL, Rosen N, Shapiro L, Sloan K. Pathway to dry skin prevention and treatment. J Cutan Med Surg. 2012 Jan-Feb;16(1):23-31. doi: 10.1177/120347541201600106.
Other Identifiers
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CLEER-001
Identifier Type: -
Identifier Source: org_study_id
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