FS2 Safety and Tolerability Study in Healthy Volunteers
Cicatrix, Cicatrix, Hypertrophic, Keloid
About this trial
This is an interventional treatment trial for Cicatrix
Eligibility Criteria
Inclusion Criteria:
- Healthy males or females between the ages of 18 and 65
- English as a primary language, or English as a second language (ESL) but completely fluent and do not require a translator
Exclusion Criteria:
- Pregnant, or attempting to become pregnant (NB: Pregnancy tests will be administered at the screening and baseline visit.)
- History of chronic skin conditions (e.g: eczema, psoriasis, etc.)
- Use of oral anti-histamines in the past month
- Use of systemic steroids in the past month
- Chronic use of NSAIDs or other anti-inflammatory medications
- Known immunosuppression or immunosuppressive illness
- Known sensitivity to parabens
- Known allergy to the the bandage adhesive
- English as a second language (ESL) and require a translator.
Sites / Locations
- BCPFF Burn & Wound Healing Lab
Arms of the Study
Arm 1
Arm 2
Other
Other
Acute Sensitivity Test to FS2 cream
Chronic Sensitivity Test to FS2 cream
Twenty (20) healthy volunteers will be assigned volunteer numbers and will have a testing areas identified by permanent marker on their backs. Pouches containing 0.00% (placebo), 0.15%, 0.25%, 0.4% and 0.5% of FS2 will be randomly applied to an occlusive, transparent dressing (Tegaderm) and applied to each test area once for 24 hours. The pouch order will be random, generated by the www.random.org list generator each application. Patients will be evaluated at 24 hours post application for skin reactions and adverse reactions by a blinded observer recorded. Before and after photographs will be taken.
Twenty (20) randomized healthy volunteers will be assigned numbers and will have a single testing area identified by permanent marker on either shoulder or upper back. Volunteers will be educated how to apply a pouch of cream to an occlusive, transparent dressing (Tegaderm) and place it on the test site every 24 hours for 30 days. The date and time of first application will be recorded. Baseline urine and serum measurements of drug concentration (presumed absent), as well as complete blood count, liver enzymes, blood urea nitrogen, and creatinine will be taken on Day 0 (the initial enrollment of each part). The volunteers will be seen in follow-up at day 1, day 5, day 15, and day 30.