Clinical trial NCT04417647: G-Wound (VZ for Wound Treatment)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds
Wound Heal
Keywords: Wound
Healing
Lead sponsor: Glock Health, Science and Research GmbH
Sponsor class: INDUSTRY
First posted: 2020-06-05
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects
2. Age 18-45 years at time of screening
3. Subjects are in good clinical and mental health as established by medical history and physical examination
4. Subject agrees to be compliant with study related visit and treatment schedule
5. Written informed consent

Exclusion Criteria:

1. 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
2. Use of topical (in the skin area of investigation) or systemic antibiotics within the last 4 weeks before study enrolment
3. 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
4. Subjects with any known coagulation disorder
5. Subjects who have pigmented skin (Fitzpatrick Classification Level V - VI) due to an increased susceptibility to hypertrophic and keloid scarring
6. History of wound healing abnormalities or a medical condition that is known to be associated with abnormal wound healing
7. Chronic inflammatory dermatological disease
8. History of chronic autoimmune diseases such as, but not restricted to rheumatoid arthritis, inflammatory bowel disease, lupus erythematodes
9. Subjects diagnosed with Diabetes Type I or II
10. Lack of 2-point discrimination above 10 cm as assessed using an aesthesiometer
11. Tattoos, scars, burns, rashes or hyper- or hypopigmentation in the region of planned punch biopsy
12. Evidence of active infectious disease including HIV and hepatitis B or C
13. Current smoker (or any kind of nicotine consumption)
14. Known allergies to biopsy numbing medication, wound cleansing solution and wound dressing
15. Known hypersensitivity to aluminium and/or silicon
16. Allergy requiring medical treatment within the last 4 weeks prior to screening
17. Active infection or fever \> 38°C within the last 7 days prior to randomization
18. Clinically relevant abnormalities in the laboratory testing, vital signs, ECG or physical examination
19. Alcohol abuse or a positive urine screen for drugs of abuse at screening
20. Participation in another clinical trial with an investigational day within the last 4 weeks before study participation
21. 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

Primary outcomes:
measure: Local tolerability of IMD
timeFrame: 14 days
Secondary outcomes:
measure: Change in wound size
timeFrame: 14 days
measure: Wound closure
timeFrame: 1 day
measure: Wound healing and condition
timeFrame: 14 days
measure: Histological evaluation
timeFrame: 2 days
measure: Investigator's satisfaction on topical applicability
timeFrame: 14 days
measure: Change in local pain intensity
timeFrame: 14 days
measure: Adverse Events and Serious Adverse Events
timeFrame: 28 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Michael Wolzt, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: