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Topical Gel

HT-001 for Skin Side Effects from Cancer Therapy (CLEER Trial)

Phase 2
Recruiting
Led By Milan Anadkat, MD
Research Sponsored by Hoth Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 7, 21, 35, 42, 56

Summary

This trial will explore if HT-001 Topical Gel can safely reduce skin toxicities associated with EGFR inhibitors and improve patient quality of life.

Who is the study for?
This trial is for adults over 18 with cancer, who are starting EGFRI treatment within 4 weeks and have developed a rash or symptoms of it. They must be able to consent, attend visits, expect to live at least 3 months, follow contraceptive rules, and have an ECOG status of 0-2. Excluded are those with less than 8-week EGFRI therapy plan, recent radiation to head/neck/trunk, active infections or uncontrolled diseases that could affect the study's outcome.
What is being tested?
The trial tests HT-001 Topical Gel in various concentrations (0.5%, 1%, and 2%) against a placebo for treating skin toxicities caused by EGFR inhibitors in cancer patients. It has two phases: an open-label phase where all receive HT-001 and a blinded phase where participants get either the gel or placebo randomly.
What are the potential side effects?
While specific side effects aren't listed here, typical concerns may include local skin reactions like redness or irritation at the application site. Since this is a topical treatment being tested for safety and tolerability as well as efficacy, close monitoring will identify any potential adverse effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 7, 21, 35, 42, 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 7, 21, 35, 42, 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acneiform Rash Investigator's Global Assessment Scale [ARIGA ]
Pharmacokinetics of HT-001 applied topically [Cohort 1] - Area Under the Curve (AUC)
Pharmacokinetics of HT-001 applied topically [Cohort 1] - Peak Plasma Concentration (Cmax)
Secondary study objectives
Body weight
Change in acneiform rash severity
EGFR Inhibitor dose reduction or discontinuation
+8 more
Other study objectives
Change in Quality of Life (QoL)
Scoring system for paronychia related to oncologic treatments (SPOT)
Xerosis Severity Scale

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-Label PK CohortExperimental Treatment1 Intervention
Topical treatment with HT-001 2% Gel unblinded.
Group II: Randomized, Double Blind CohortPlacebo Group4 Interventions
Topical treatment with HT-001 (2%, 1%, or 0.5%) or placebo (HT-001 vehicle), blinded

Find a Location

Who is running the clinical trial?

Hoth Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
31 Total Patients Enrolled
Worldwide Clinical TrialsOTHER
64 Previous Clinical Trials
14,623 Total Patients Enrolled
Milan Anadkat, MDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

HT-001 (Topical Gel) Clinical Trial Eligibility Overview. Trial Name: NCT05639933 — Phase 2
Paronychia Research Study Groups: Randomized, Double Blind Cohort, Open-Label PK Cohort
Paronychia Clinical Trial 2023: HT-001 Highlights & Side Effects. Trial Name: NCT05639933 — Phase 2
HT-001 (Topical Gel) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05639933 — Phase 2
~9 spots leftby Dec 2024
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