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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

Adult patient (≥ 18 years of age at Screening/Baseline [V1]) prescribed an approved EGFRI to treat cancer with indication within the approved labeling for the EGFRI

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, 7, 21, 35, 42, 56

Awards & highlights

CLEER Trial 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.Check my eligibility

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.See study design

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.

CLEER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult prescribed an EGFRI for my cancer treatment.

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I can take care of myself and am up and about more than half of my waking hours.

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I have a mild rash covering less than 30% of my body.

CLEER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, 7, 21, 35, 42, 56

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Body weight

Change in acneiform rash severity

EGFR Inhibitor dose reduction or discontinuation

+8 more

Other outcome measures

Change in Quality of Life (QoL)

Scoring system for paronychia related to oncologic treatments (SPOT)

Xerosis Severity Scale

CLEER 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

0 / 3Eligibility criteria met

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

61 Previous Clinical Trials

14,235 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being accepted for this investigation?

"The data on clinicaltrials.gov suggests that this research trial is actively seeking participants as of today. This project was initially published on February 7th 2023 and has recently been amended on the 13th day of February in the same year."

Answered by AI

To what degree is Open-Label PK Cohort a secure option for those involved?

"Because of the Phase 2 trial nature, which has only collected data on safety but not efficacy, our team at Power gave Open-Label PK Cohort a score of 2 when it comes to safety."

Answered by AI

What is the current participant count for this experiment?

"Affirmative. According to information hosted on clinicaltrials.gov, this research initiative is still searching for participants since it was first posted on February 7th, 2023 and recently updated on the 13th of that month. The study requires 152 individuals from a single medical centre."

Answered by AI

What are the desired outcomes of this clinical endeavor?

"This 6 week long study seeks to measure the pharmacokinetics of HT-001 when applied topically. The primary outcome is Area Under the Curve (AUC). Other objectives include determining Time To Improvement using a novel 5 point scale, evaluating EGFR Inhibitor dose reduction or discontinuation and conducting Physical Examinations with an accompanying AE form for any noteworthy changes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05639933.