Théo Boyer, project manager at Indero, explores how novel methodologies could influence the collection of biological data in future clinical research.
Dermatology trials frequently rely on blood draws and skin biopsies to evaluate inflammatory pathways, pharmacodynamic activity and drug exposure.
While these methods are well established, their invasiveness and practical limitations may hinder successful development of new therapies. For example, taking skin biopsies increases protocol complexity, limits repeat sampling and affects recruitment, especially in studies involving children.
As dermatology research becomes increasingly biomarker-driven, investigators are exploring alternative methods that may reduce patient burden while preserving access to meaningful molecular data.
One emerging approach is the sampling of dermal interstitial fluid (dISF), which is the fluid that surrounds skin cells and serves as an intermediary between the circulatory system and local tissues.
Using dISF as a sampling matrix
dISF contains a broad range of molecular constituents, including inflammatory mediators and proteins that are traditionally measured in blood or tissue samples.
Advances in microneedle-based technologies now allow the collection of dISF through minimally invasive techniques that only penetrate the upper dermal layer, reducing patient discomfort and providing a promising diagnostic alternative, particularly for evaluating skin conditions.
Recent studies have shown that biomarkers detected in dISF align with those obtained through established methods such as biopsies, tape stripping or venous sampling.
In early-phase research, this comparative approach is being used to better underst=and where dISF sampling may add value. Although research is ongoing, initial observations suggest that a range of inflammatory markers relevant to conditions such as atopic dermatitis and psoriasis can be detected in dISF.
Investigators are also examining its potential role in pharmacokinetic assessments, particularly in understanding drug presence within the skin tissue.
Supporting patient-centered trial design
One of the primary drivers behind interest in dISF sampling is improving the patient experience, as traditional approaches such as biopsies and tape stripping can be uncomfortable.
Biopsies requiring tissue excision may leave residual marks and cause infections and are often impractical to repeat. Tape stripping, while less invasive, can still cause some discomfort and irritation when performed repeatedly.
Théo Boyer, Project Manager at Indero, explained: “dISF occupies the interstitial space of the dermis, bathing the dermal cells, and has an inherent biochemical relationship with blood.
It has attracted interest as a potential minimally invasive sampling matrix in dermatology research because recruitment performance in clinical trials is frequently influenced by the invasiveness of the study procedures. The use of minimally invasive approaches may therefore help to lower this barrier, particularly when repeated sampling is required.”
This new approach may be particularly important in advancing pediatric research. Traditional sampling methods can be difficult to justify in young participants, where minimizing discomfort and long-term skin impact is a priority. A technique that allows molecular assessment without tissue removal could make biomarker-driven studies in these populations more feasible.
Practical and analytical considerations
As with any emerging technique, practical questions must be addressed before wider adoption. Study teams must have enhanced training on a new technique to perform the sampling method consistently, obtain reliable sample volumes and maintain quality.
Downstream analyses must also demonstrate that biomarkers measured in dISF can be interpreted meaningfully alongside established approaches. Integrating a new sampling strategy into a protocol also requires coordination across clinical, analytical and regulatory functions, with clear scientific justification provided to ethics committees, even when procedures are minimally invasive.
Despite these challenges, interest in alternative sampling approaches reflects a broader shift towards more patient-conscious trial designs. Molecular endpoints are increasingly incorporated into dermatology studies, and the ability to repeatedly obtain biological snapshots from the same participant may support more dynamic assessments of treatment responses.
A complementary tool in evolving research models
At present, dISF sampling is best viewed as a complementary tool, rather than a substitute for established methods. Ongoing studies will determine how comparable the dISF biomarker profiles are to those obtained from blood and tissue samples, and in which contexts this approach offers the greatest value.
Dermatology research is evolving, enabling the detection of more precise biological signals. At the same time, the participant’s experience must be considered.
Thoughtful adoption of less intrusive sampling methods, such as dISF sampling, may help to balance scientific ambition with patient comfort in modern dermatology trials, without compromising data quality.
