Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 64
Summary
- Conditions
- Atopic Dermatitis
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
This study will consist of 2 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, a...
This study will consist of 2 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.
Tracking Information
- NCT #
- NCT04544943
- Collaborators
- Novotech (Australia) Pty Limited
- Investigators
- Principal Investigator: Oscar Cumming, Dr Novatrials
Get Well Soon