Ignite Creation Date:
2024-05-06 @ 6:22 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05639933
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2022-11-14
Brief Title:
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
Sponsor:
Hoth Therapeutics Inc
Organization:
Hoth Therapeutics Inc
Study Overview
Official Title:
A Randomized Placebo-controlled Parallel Phase 2a Dose-ranging 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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLEER
Brief Summary:
The goal of this clinical trial is to learn about HT-001 Topical Gel for treatment of EGFR inhibitor-induced skin toxicities The main questions it aims to answer are
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 investigators 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
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 investigators 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
Detailed Description:
This is a randomized double-blind placebo-controlled multi-center Phase 2a dose-ranging study to evaluate the efficacy safety and tolerability of HT-001 for treatment of EGFRI-induced skin toxicity The study will include adult patients 18 years of age scheduled to receive initial or repeat EGFRI therapy
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 2221 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 strengths 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
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 2221 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 strengths 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None