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HT-001 for Skin Side Effects from Cancer Therapy (CLEER Trial)
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.
CLEER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCLEER Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CLEER Trial Design
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Who is running the clinical trial?
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- I can and will attend all required visits, both in person and via telehealth.I have severe skin or systemic side effects from EGFRI therapy.I haven't taken any experimental drugs within the last 4 weeks or 8 half-lives of the drug.I haven't changed my antibiotic dose in the last 14 days, except for improvements.I am an adult prescribed an EGFRI for my cancer treatment.I have taken aprepitant or similar medication in the last 4 weeks.I am undergoing or have recently had radiation therapy to my head, neck, or upper trunk along with EGFRI therapy.I do not have any active infections or uncontrolled diseases that could affect the study.I haven't taken pimozide or certain strong medications affecting liver enzymes in the last 30 days.I can take care of myself and am up and about more than half of my waking hours.I have a mild rash covering less than 30% of my body.I haven't changed my skin medication doses in the last 14 days.I am willing and able to follow the birth control requirements.I haven't increased my steroid dose recently, except for low doses for nausea from chemo.
- Group 1: Randomized, Double Blind Cohort
- Group 2: Open-Label PK Cohort
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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