NCT04417647CompletedNot Applicable
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
Glock Health, Science and Research GmbH1 site in 1 country12 target enrollmentStarted: June 5, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Local tolerability of IMD
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Group 1
Experimental
Proximal wound SoC treatment - Distal wound VZ application
Intervention: VZ powder (purified clinoptilolite) (Device)
Group 1
Experimental
Proximal wound SoC treatment - Distal wound VZ application
Intervention: Standard of care (SoC) (Procedure)
Group 2
Experimental
Distal wound SoC treatment - Proximal wound VZ application
Intervention: VZ powder (purified clinoptilolite) (Device)
Group 2
Experimental
Distal wound SoC treatment - Proximal wound VZ application
Intervention: Standard of care (SoC) (Procedure)
Outcomes
Primary Outcomes
Local tolerability of IMD
Time Frame: 14 days
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.
Secondary Outcomes
- Wound closure(1 day)
- Histological evaluation(2 days)
- Investigator's satisfaction on topical applicability(14 days)
- Adverse Events and Serious Adverse Events(28 days)
- Change in wound size(14 days)
- Wound healing and condition(14 days)
- Change in local pain intensity(14 days)
Investigators
Study Sites (1)
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