In clinical research, every decision about product development hinges on data. For topical drugs and dermatology products in particular, gathering that data has always been a challenge. How do you know, with certainty, that an active ingredient is doing what it is supposed to do once it reaches the skin? Traditional approaches have left sponsors with indirect, expensive, and often slow answers.
Dermal open-flow microperfusion (dOFM) is changing this. By enabling researchers to study topical absorption and activity directly within living skin, dOFM provides an unprecedented look at drug behavior at the microscopic level. For CROs, this technology represents more than a scientific breakthrough, it is a new operational advantage.
Historically, sponsors and CROs have relied on in vitro diffusion tests or invasive biopsies to study topical performance. In vitro methods are limited because they cannot fully replicate the complexity of living human skin, while biopsies are invasive and capture only a static snapshot. Neither method offers the type of continuous, dynamic data required to understand how drugs interact with the skin over time.
The result? Costly trial phases often move forward with incomplete data, leading to delays, redesigns, or in some cases, failure to prove efficacy.
Dermal dOFM solves this problem by collecting real-time samples from within the dermis using ultra-thin probes. This allows scientists to measure concentrations of active compounds, metabolites, and PD markers for local biological responses continuously and with minimal disruption to the patient.
The data provided is a true pharmacokinetic and Pharmacodynamic profile of topicals, something that until now has been nearly impossible to capture. With this information in hand, sponsors can:
From a CRO operations perspective, the true power of dermal dOFM lies in its efficiency. Because dOFM can generate rich, continuous datasets from small patient groups, sponsors can obtain high quality data at low cost early in the development process.
This early clarity saves time and resources downstream. Instead of advancing uncertain formulations into larger, more expensive trials, CROs can help sponsors identify promising candidates quickly, or pivot before further investment. It is a model that protects timelines, budgets, and ultimately, patient safety.
Regulators have long struggled with assessing bioequivalence for topical generics. dOFM provides objective, quantitative data that can demonstrate equivalence far more clearly than traditional methods. This not only facilitates regulatory approvals but also lowers barriers to market entry for new products.
For sponsors, that means reduced costs, accelerated development, and the ability to bring competitive therapies or generics to market faster. A key value is early insights into how a drug actually works and using that to knowledge for later stage clinical research. For CROs, it strengthens our role as a partner in navigating both scientific and regulatory hurdles.
At its core, dermal dOFM gives CROs the ability to deliver something sponsors consistently demand: early answers supported by robust science. It’s not just about better data, rather it’s about better decision-making. dOFM brings value to the three stakeholders: regulators, Sponsors and CROs.
By incorporating dOFM into early-phase studies, CROs can help clients reduce trial risk, control costs, and gain confidence in their development pipelines. For sponsors, that translates into faster paths to proof of concept and stronger positioning for later-phase success.
Dermal dOFM represents a genuine revolution in how we study topicals. By capturing what happens beneath the skin in real time, this technology bridges the gap between preclinical models and patient outcomes.
For CROs, it is more than a scientific innovation,it is an operational tool that enables us to obtain high quality data at low cost early, helping sponsors make faster, smarter, and safer decisions.
The future of dermatological research depends not only on what we can measure, but how quickly and efficiently we can deliver those insights. With dermal dOFM, CROs are positioned to lead that future.
