G-Wound (VZ for Wound Treatment)

Study Overview
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Brief Summary
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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

Official Title
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A Prospective, Randomized, Open-label, Controlled, Exploratory Trial to Investigate the Safety and Tolerability of Topically Administered VZ in Healthy Male Subjects With Artificial Dermal Wounds

Conditions
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Wounds, Wound Heal

Intervention / Treatment
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* Device: VZ powder (purified clinoptilolite)
* Procedure: Standard of care (SoC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects Age 18-45 years at time of screening Subjects are in good clinical and mental health as established by medical history and physical examination Subject agrees to be compliant with study related visit and treatment schedule Written informed consent Exclusion Criteria: Regular use of medications affecting the blood clotting process (e.g. aspirin or any other over-the-counter medicine or complimentary health product affecting the blood clotting process) or immunosuppressive drugs. Aspirin should not be taken in the 10 days prior to study participation or during the study Use of topical (in the skin area of investigation) or systemic antibiotics within the last 4 weeks before study enrolment History of cancer (except for non-melanoma skin cancer) within the previous 12 months or treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy, hormone therapy for cancer treatment, targeted therapy or gene therapy) within 12 months before the first administration of investigational product or at any time during the study Subjects with any known coagulation disorder Subjects who have pigmented skin (Fitzpatrick Classification Level V - VI) due to an increased susceptibility to hypertrophic and keloid scarring History of wound healing abnormalities or a medical condition that is known to be associated with abnormal wound healing Chronic inflammatory dermatological disease History of chronic autoimmune diseases such as, but not restricted to rheumatoid arthritis, inflammatory bowel disease, lupus erythematodes Subjects diagnosed with Diabetes Type I or II Lack of 2-point discrimination above 10 cm as assessed using an aesthesiometer Tattoos, scars, burns, rashes or hyper- or hypopigmentation in the region of planned punch biopsy Evidence of active infectious disease including HIV and hepatitis B or C Current smoker (or any kind of nicotine consumption) Known allergies to biopsy numbing medication, wound cleansing solution and wound dressing Known hypersensitivity to aluminium and/or silicon Allergy requiring medical treatment within the last 4 weeks prior to screening Active infection or fever > 38°C within the last 7 days prior to randomization Clinically relevant abnormalities in the laboratory testing, vital signs, ECG or physical examination Alcohol abuse or a positive urine screen for drugs of abuse at screening Participation in another clinical trial with an investigational day within the last 4 weeks before study participation Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to the sponsor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Proximal wound SoC treatment - Distal wound VZ application | Device: VZ powder (purified clinoptilolite)<br>* 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).<br>Procedure: Standard of care (SoC)<br>* 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.<br>|
| Experimental: Group 2<br>Distal wound SoC treatment - Proximal wound VZ application | Device: VZ powder (purified clinoptilolite)<br>* 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).<br>Procedure: Standard of care (SoC)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in wound size | Change in wound size between baseline and End of Treatment (EoT) assessed by photographic analysis | 14 days | 
| Wound closure | Presence or absence of complete wound closure at End of Treatment (EoT) visit | 1 day | 
| Wound healing and condition | Wound healing and wound condition parameters assessed as a dichotomous outcome by the investigator | 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 | 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. | 14 days | 
| Change in local pain intensity | 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. | 14 days | 
| Adverse Events and Serious Adverse Events | Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound, Healing