The study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of Propionibacterium acnes. The test product will be applied once daily for 4 weeks. Exploratory measures include whether the topical product decreases the amount of a bacteria associated with acne (P. acnes).
This is a single center, observer blinded, randomized, multiple dose study with 3 doses of NVN1000 and vehicle applied once daily for 4 weeks. There are 4 arms to the study (3 active and 1 vehicle).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
2% NVN1000 Topical Gel once daily for 4 weeks
4% NVN1000 4% Topical Gel applied once daily 4 weeks
8% NVN1000 Topical Gel applied once daily for 4 weeks
KGL, Inc
Broomall, Pennsylvania, United States
Cutaneous tolerability Evaluation
Cutaneous tolerability evaluations to include erythema, scaling, dryness, puritus and burning/stinging using a 4-category scale with scores ranging from 0-3 (0=none, 1=mild, 2=moderate, 3 - severe).
Time frame: 4 weeks
Safety Assessment
Comparison of adverse events between groups.
Time frame: 4 weeks
Safety Assessment
Change from baseline in HCT (L/L)
Time frame: 4 weeks
Safety Assessment
Change from baseline in HGB, MCHC (g/L)
Time frame: 4 weeks
Safety Assessment
Change from baseline in % methemoglobin (%)
Time frame: 4 weeks
Safety Assessment
Change from baseline in % Basophils (%)
Time frame: 4 weeks
Safety Assessment
Change from baseline in % Eosinophils (%)
Time frame: 4 weeks
Safety Assessment
Change from baseline in % Lymphocytes (%)
Time frame: 4 weeks
Safety Assessment
Change from baseline in MCH (pg)
Time frame: 4 weeks
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Vehicle Topical Gel applied once daily
Safety Assessment
Change from baseline in MCV, MPV (fL)
Time frame: 4 weeks
Safety Assessment
Change from baseline in % Monocytes (%)
Time frame: 4 weeks
Safety Assessment
Change from baseline in % Neutrophils (%)
Time frame: 4 weeks
Safety Assessment
Change from baseline in Platelet Count, WBC (10 \^ 9/L)
Time frame: 4 weeks
Safety Assessment
Change from baseline in % RDW (%)
Time frame: 4 weeks
Safety Assessment
Change from baseline in RBC (10 \^ 12/L)
Time frame: 4 weeks
Safety Assessment
Change from baseline in Albumin, Protein, Total (g/L)
Time frame: 4 weeks
Safety Assessment
Change from baseline in Alkaline Phosphatase, ALT, AST, (U/L)
Time frame: 4 weeks
Safety Assessment
Change from baseline in Bicarbonate, Bun, Calcium, Chloride, Glucose, Phosphorus, Potassium, Sodium (mmol/L)
Time frame: 4 weeks
Safety Assessment
Change from baseline in Bilirubin Direct, Bilirubin Total, Creatinine (umol/ L)
Time frame: 4 weeks