This website is intended exclusively for healthcare professionals and medical device manufacturers.
By accessing this site, you confirm that you belong to one of its of these categories and understand that the information provided is specifically intented for a professional audience.
"MANAGING AESTHETIC PRACTICE IN 2025/2026"
The present study evaluates the transdermal absorption of a novel exosome-based formulation, PKH26@MG-EXO-SKIN, using the reconstructed full-thickness human skin model KeraSkin-FT™. Applying microneedles significantly enhanced the skin penetration of the formulation, enabling delivery beyond the stratum corneum into deeper skin layers, including the dermis. This research suggests microneedle-assisted delivery may be a highly effective strategy for improving the bioavailability of active dermatological agents.
Transdermal delivery remains a challenge in dermatological research due to the skin’s natural barrier properties, especially those conferred by the stratum corneum. To overcome this, microneedleassisted systems have emerged as promising alternatives for enhancing skin permeability.
This study investigates the depth and kinetics of absorption of PKH26@MG-EXO-SKIN—an exosomebased active agent—using a validated in vitro model and OECD guideline-compliant methodology.
KeraSkin-FT™, a reconstructed full-thickness human skin model, was used. It mimics human skin architecture with basal, spinous, granular, and keratin layers and includes a fibroblast-populated dermal matrix.
PKH26@MG-EXO-SKIN is a formulation containing mesenchymal stem cell-derived extracellular vesicles (MBTC-MSC-EXO) stained with PKH26, a lipophilic fluorescent dye for tracking.
Nine test groups were created (n=2 per group), covering treatment durations of 1, 3, 6, and 24 hours with and without microneedle application.
50 µL of test formulation was applied to KeraSkinFT™. For microneedle-assisted groups, a microneedle device (Dermapenworld) was used prior to application.
After treatment, samples were incubated at 37°C with5% CO₂. Tissues were then fixed, cryosectioned, stained with DAPI, and analyzed via fluorescence microscopy.
Microscopic observations revealed time- and methoddependent absorption profiles:
Without microneedles:
With microneedles:
Fluorescence microscopy images visually confirmed progressive absorption at each time point. Control vs. microneedle comparison highlighted stark differences in penetration depth.
Treatment of PKH26@MG-EXO_SKIN
Treatment of PKH26@MG-EXO_SKIN after microneedle application
Treatment of PKH26@MG-EXO_SKIN
Treatment of PKH26@MG-EXO_SKIN after microneedle application
The study confirms that exosome-containing formulations alone have limited capability to traverse the stratum corneum barrier. However, when combined with microneedle pre-treatment, significant transdermal absorption occurs. This aligns with previous findings on microneedle-enhanced delivery and supports the growing application of microchannelfacilitated skin therapies.
Given the increasing popularity of exosomebased treatments in regenerative and aesthetic dermatology, enhancing their delivery is crucial. The results underscore the compatibility of KeraSkinFT™ with OECD TG 428 guidelines and its suitability as an alternative to animal testing for topical delivery research.
PKH26@MG-EXO-SKIN exhibits enhanced transdermal delivery when used in conjunction with microneedle application. These findings suggest promising utility in clinical dermatology and cosmeceutical development, particularly for treatments requiring deeper skin penetration.
