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 enrollmentJune 5, 2020

ConditionsWounds Wound Heal

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Wounds
Sponsor: Glock Health, Science and Research GmbH
Enrollment: 12
Locations: 1
Primary Endpoint: Local tolerability of IMD
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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

Registry

clinicaltrials.gov

Start Date

June 5, 2020

End Date

August 13, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Glock Health, Science and Research GmbH

Responsible Party

Sponsor

Eligibility Criteria

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

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.