Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04544943
Status:
COMPLETED
Last Update Posted:
2022-11-17
First Post:
2020-08-27
Brief Title:
Safety Tolerability Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis
Sponsor:
Hoth Therapeutics Inc
Organization:
Hoth Therapeutics Inc
Study Overview
Official Title:
A Randomised Double-Blind Vehicle Controlled Sequential Group Study to Determine the Safety Tolerability Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2022-11
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:
None
Brief Summary:
This is a Phase 1 randomised double-blind vehicle controlled study to determine the safety tolerability PK and efficacy of twice daily application of topical BioLexa lotion administered for 28 days in adult healthy subjects in adult patients with mild to moderate AD and in adolescent patients with mild to moderate AD
Detailed Description:
This study will consist of 3 parts Part A Part A will consist of Cohort 1 constituting of heathy subjects The total body surface area BSA dosed will be either 9 or 27 BSA for Cohort 1 subjects Part A will include both an active-control lotion base 01 gentamicin and a placebo control applied at 9 or 27 BSA
Part B Part B will consist of Cohort 2 made up of adult mild to moderate AD patients The minimum BSA dosed will be 3 BSA and the maximum will be 27 BSA for patients in Cohort 2 Part B will include both an active-control lotion base 01 gentamicin and a placebo control
Open-Label Cohort After closure of Part B open-label enrolment of patients with mild to moderate atopic dermatitis affecting 3-27 BSA for treatment with BioLexa for 14 days unblinded
Part B Part B will consist of Cohort 2 made up of adult mild to moderate AD patients The minimum BSA dosed will be 3 BSA and the maximum will be 27 BSA for patients in Cohort 2 Part B will include both an active-control lotion base 01 gentamicin and a placebo control
Open-Label Cohort After closure of Part B open-label enrolment of patients with mild to moderate atopic dermatitis affecting 3-27 BSA for treatment with BioLexa for 14 days unblinded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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