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In situ bio-distribution and residency of a topical anti-inflammatory using fluorescence lifetime imaging microscopy.

BACKGROUND: In this Phase I clinical trial, the spatial bio-distribution and residency of GSK2894512 within the epidermis and dermis of healthy human participants was investigated non-invasively using fluorescence lifetime imaging microscopy (FLIM). Two topical drug formulations containing 1% GSK2894512 were applied to the right and left forearms of 6 participants for 7 consecutive days, followed by 7 days of observation for residency.

OBJECTIVE: FLIM images were obtained daily throughout the study approximately every 24 hours. During the treatment phase of the study, images were collected from each participant pre-treatment, reflecting the residual dose from the previous day. Three punch biopsies from each participant of one formulation was obtained from the treated region during the post-treatment follow-up period between days 8 and 14 for comparison with FLIM results.

RESULTS: Cellular and sub-cellular features associated with different epidermal and dermal layers were visualized non-invasively, down to a depth of 200 μm. Results yielded 3D maps of GSK2894512 spatial distribution and residency over time. This fluorescence data provided a marker that was used as a monitor for day-to-day variance of drug presence and residency post-application.

CONCLUSIONS: These results suggest FLIM could be a viable alternative to skin biopsies without the usual patient discomfort and limitations, thereby enabling the direct measurement of skin distribution through longitudinal monitoring. These results are the first step in establishing the unique capabilities that multi-photon imaging could provide to patients through non-invasive drug detection. This article is protected by copyright. All rights reserved.

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