A Phase 1 randomized, open‐label clinical trial to evaluate the effect of a far‐infrared emitting patch on local skin perfusion, microcirculation and oxygenation

Author:

van Kraaij Sebastiaan J. W.12,Hamblin Michael R.3ORCID,Pickering Gisele4,Giannokopoulos Bill5,Kechemir Hayet6,Heinz Moritz6,Igracki‐Turudic Iva7,Yavuz Yalçin1,Rissmann Robert18,Gal Pim12

Affiliation:

1. Centre for Human Drug Research Leiden the Netherlands

2. Leiden University Medical Centre Leiden the Netherlands

3. Laser Research Centre, Faculty of Health Science University of Johannesburg Johannesburg South Africa

4. Clinical Investigation Center CIC Inserm 1405 University Hospital Clermont‐Ferrand Clermont‐Ferrand France

5. CHC Science Hub Sanofi Athens Greece

6. Research & Development Sanofi Chilly‐Mazarin France

7. CHC Science Hub Sanofi Frankfurt Germany

8. Leiden Academic Centre for Drug Research Leiden the Netherlands

Abstract

AbstractFar‐infrared radiation (FIR) has been investigated for reduction of pain and improvement of dermal blood flow. The FIRTECH patch is a medical device designed to re‐emit FIR radiated by the body. This phase 1 study was conducted to evaluate the local effects of the FIRTECH patch on local skin perfusion, microcirculation and oxygenation. This prospective, randomized, open‐label, parallel designed study admitted 20 healthy participants to a medical research facility for treatment for 31 h on three anatomical locations. During treatment, imaging assessments consisting of laser speckle contrast imaging, near‐infrared spectroscopy, side‐stream dark‐field microscopy, multispectral imaging and thermography were conducted regularly on patch‐treated skin and contralateral non‐treated skin. The primary endpoint was baseline perfusion increase during treatment on the upper back. Secondary endpoints included change in baseline perfusion, oxygen consumption and temperature of treated versus untreated areas. The primary endpoint was not statistically significantly different between treated and non‐treated areas. The secondary endpoints baseline perfusion on the forearm (least square means [LSMs] difference 2.63 PU, 95% CI: 0.97, 4.28), oxygen consumption (LSMs difference: 0.42 arbitrary units [AUs], 95% CI: 0.04, 0.81) and skin temperature (LSMs difference 0.35°C, 95% CI: 0.16, 0.6) were statistically significantly higher in treated areas. Adverse events observed during the study were mild and transient. The vascular response to the FIRTECH patch was short‐lived suggesting a non‐thermal vasodilatory effect of the patch. The FIRTECH patch was well tolerated, with mild and transient adverse events observed during the study. These results support the therapeutic potential of FIR in future investigations.

Funder

Sanofi

Publisher

Wiley

Subject

Dermatology,Molecular Biology,Biochemistry

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