This is a prospective, randomized, open-label, controlled, exploratory trial that aims to investigate the local skin tolerability of topically administered VZ and to evaluate efficacy and safety parameters associated with improved wound condition and healing
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
VZ powder will be applied topically to the open surface of the verum treatment-assigned wound to cover the entire wound area. Following each VZ application, wounds will be protected by wound dressing (non-adhesive wound dressing (AdapticTM) and conventional protective Mepore® dressing).
wound cleansing (0.9% saline solution) and wound dressing (non-adhesive wound dressing (AdapticTM) and conventional protective Mepore® dressing) will be applied to the SoC-assigned wound.
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria
Local tolerability of IMD
Local tolerability of IMD assessed using erythema severity score: a scale from 0 - 4 (0 = no visible reaction, 1 = faint, minimal erythema, 2 = erhythema, 3 = erythema with induration of vesicles, 4 = severe erythema with induration, vesicles or bullae or pustules and/ulceration) with 0 being best and 4 being worst.
Time frame: 14 days
Change in wound size
Change in wound size between baseline and End of Treatment (EoT) assessed by photographic analysis
Time frame: 14 days
Wound closure
Presence or absence of complete wound closure at End of Treatment (EoT) visit
Time frame: 1 day
Wound healing and condition
Wound healing and wound condition parameters assessed as a dichotomous outcome by the investigator
Time frame: 14 days
Histological evaluation
Descriptive histological evaluation of wound healing by H\&E and Masson trichrome staining as well as by immunostaining against biomarkers of the biopsy specimens obtained at baseline and at EoT
Time frame: 2 days
Investigator's satisfaction on topical applicability
Investigator's satisfaction on topical applicability of VZ evaluated via a 5-point Likert scale: a scale from 1 - 5: 5 = extremely satisfied, 4 = very satisfied, 3 = moderately satisfied, 2 = slightly satisfied, 1 = not at all satisfied) with 5 being best and 1 being worst.
Time frame: 14 days
Change in local pain intensity
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Change in local pain intensity based on the Visual Analogue Scale (VAS) when compared to SoC-treated wounds with a scale from 0-10: 0 - no pain and 10 - worst possible pain.
Time frame: 14 days
Adverse Events and Serious Adverse Events
Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 28 days