Status:
COMPLETED
G-Wound (VZ for Wound Treatment)
Lead Sponsor:
Glock Health, Science and Research GmbH
Conditions:
Wounds
Wound Heal
Eligibility:
MALE
18-45 years
Phase:
NA
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 param...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04417647
Start Date
June 5 2020
End Date
August 13 2020
Last Update
November 13 2020
Active Locations (1)
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1
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria