A single center, open-label pilot study in healthy subjects using dermal open flow microperfusion to collect body fluids for bioanalytical matrix validation and to explore the effects of topical product removal on dermal kinetics

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515780-62-00

Acronym

FDA03A1

Enrollment

Registered

2024-11-18

Start date

2025-02-05

Completion date

2025-07-03

Last updated

2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No medical condition is being investigated in this clinical trial.

Brief summary

Dermal PK profile (drug concentration over time) for defined removal times, Dermal PK parameter (e.g. AUC, Cmax, tmax) for defined removal times, Serum PK profile (drug concentration over time)

Interventions

DRUGMETRONIDAZOLE

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Dermal PK profile (drug concentration over time) for defined removal times, Dermal PK parameter (e.g. AUC, Cmax, tmax) for defined removal times, Serum PK profile (drug concentration over time)	—

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026