Validity, reliability, and feasibility of durometer measurements of scleroderma skin disease in a multicenter treatment trial

Abstract

Objective. To determine the validity, reliability, and feasibility of durometer measurements of skin hardness as an outcome measure in clinical trials of scleroderma. Methods. Skin hardness was measured during a multicenter treatment trial for scleroderma using handheld digital durometers with a continuous scale. Skin thickness was measured by modified Rodnan skin score (MRSS). Other outcome data collected included the Scleroderma Health Assessment Questionnaire. In a reliability exercise in advance of the trial, 9 investigators examined the same 5 scleroderma patients by MRSS and durometry. Results. Forty-three patients with early diffuse cutaneous systemic sclerosis were studied at 11 international centers

Irradiation with Water-Filtered Infrared A plus Visible Light Improves Cutaneous Scleroderma Lesions in a Series of Cases

“…Moreover, Kissin et al demonstrated that durometry enables detection of even minor changes in skin hardness over time [24]. For our investigations we used a new durometer and observed – in line with previous studies – that durometry is painless and can be easily performed [23,24,25]. Durometry was suitable for the documentation of the success of therapy and to motivate patients to continue treatments.…”

“…In earlier investigations durometry has been proven to be reliable in the assessment of morphea [23,24,25]. Moreover, Kissin et al demonstrated that durometry enables detection of even minor changes in skin hardness over time [24].…”

Investigation of dental materials as skin simulants for forensic skin/skull/brain model impact testing

“…Regarding their hardness, the human skin data reported in the literature [6][7][8]25] has quite a wide range (0-65DU), which is mainly due to the large number of various sites tested. All the tested silicone materials lie within this range, however one must keep in mind that there is a lack of scalp hardness values reported in the current literature that has yet to be investigated.…”

“…Moreover, it is an anisotropic (force response is dependent on the force direction) and a nonlinear material [1][2][3]. Several studies have identified that human skin's mechanical behavior is dependent on a variety of factors, such as age, gender, health and weight of the donor, as well as the location of the site and its orientation [1,2,[4][5][6][7][8]. The use of human skin in test situations may potentially make it difficult to analyze any experimental results and repeating of the experiment would be problematic [9].…”

Systemische Sklerose

“…Bislang wurde allerdings nur das Durometer, das das Ausmaß der Hautverhärtung misst, in klinischen Studien validiert [28]. Um diese Hypothese zu untermauern, bedarf es der Anwendung von TNF-α-Blockern in entzündungsunabhängigen Tiermodellen der SSc [29].…”