drugset
drugset / Trial / 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

NCT04544943 ↗

Phase 1 Completed 31 enrolled Hoth Therapeutics, Inc. Novotech (Australia) Pty Limited · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-05-17
Primary completion
2022-09-21
Completion
2022-09-21

Drugs

EvaluationDrugModalityDoseRoute
Subject BioLexa Unknown 3 % Topical
Subject BioLexa Unknown 9 % Topical
Subject BioLexa Unknown 27 % Topical
Subject Gentamicin Small molecule 0.1 % Topical

Indications

atopic eczema