Comparing how topical medicines are absorbed into the skin using microperfusion
Official title: Optimized clinical dermal Open Flow Microperfusion study design to demonstrate bioequivalence based on cutaneous pharmacokinetics
Funded at Joanneum Research Forschungsgesellschaft Mbh · NIH-11247064 · Data updated 2026-11-12
This project uses a small-sample skin microperfusion method to show whether generic creams, gels, and ointments deliver the same amount of medicine into the skin as brand-name products for people who use topical treatments.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Joanneum Research Forschungsgesellschaft Mbh NIH-funded |
| Lab location | 1 site (Graz, Austria) |
| Project start | September 15, 2022 |
| Project end | August 31, 2026 |
| Funding year | 2026 |
| Award (this year) | $250,000 |
| NIH project number | 5U01FD007669-04 |
| Project ID | NIH-11247064 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal participants would be people who use or need prescription or over-the-counter topical medicines (creams, gels, ointments) and are willing to undergo brief skin sampling procedures at a clinic.
✕Less likely to help
People who do not use topical treatments or who are unwilling to have small skin-sampling procedures are unlikely to benefit directly from participating.
What this research studies
Researchers will place a tiny sampling device (dermal Open Flow Microperfusion, dOFM) in the skin to collect fluid after a topical medicine is applied and measure drug levels over time. The team will refine the clinical design and sampling procedures so these skin drug measurements can be used to demonstrate bioequivalence when laboratory matching is not possible. Work builds on prior FDA-collaborative projects that showed dOFM can sensitively measure cutaneous drug exposure and will compare different products and analytic approaches. The goal is to create a reliable, practical method regulators can accept to help bring equivalent generics to patients more affordably.
Why it matters
Potential benefit: If successful, this could help bring more lower-cost generic topical medicines to market that work like the brand-name versions.
How similar studies have gone: Previous FDA-partnered projects have shown dOFM can accurately measure drug levels in human skin, but broader regulatory acceptance for proving generic equivalence is still being advanced.
Where this research is happening
-
Joanneum Research Forschungsgesellschaft Mbh
Graz, Austria Active
Researchers
- Principal investigator: Sinner, Frank — Joanneum Research Forschungsgesellschaft Mbh
- Study coordinator: Sinner, Frank
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.