NCT04544943

Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Hoth Therapeutics, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 + 0.1% 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 + 0.1% 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).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	BioLexa- Cohort 1	Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult healthy subjects
DRUG	BioLexa- Cohort 2	Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult mild to moderate AD patients
DRUG	Placebo	Twice daily (BID) application of placebo for 14 days
DRUG	Gentamicin	Twice daily (BID) application of Gentamicin for 14 days

Timeline

• Start date: 2021-05-17
• Primary completion: 2022-09-21
• Completion: 2022-09-21
• First posted: 2020-09-10
• Last updated: 2022-11-17

Locations

1 site across 1 country: Australia