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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-11-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Hoth Therapeutics, Inc.

    lead OTHER

Principal Investigators

  • Oscar Cumming, Dr · Novatrials

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04544943 on ClinicalTrials.gov