Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% NVN1000 Topical Gel | Experimental | 2% NVN1000 Topical Gel once daily for 4 weeks |
|
| 4% NVN1000 Topical Gel | Experimental | 4% NVN1000 4% Topical Gel once daily for 4 weeks |
|
| Vehicle Topical Gel | Placebo Comparator | Vehicle Topical Gel once daily for 4 weeks |
|
| 8% NVN1000 Topical Gel | Experimental | 8% NVN1000 8% Topical Gel applied once daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% NVN1000 Topical Gel | Drug | 2% NVN1000 Topical Gel once daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | Comparison of adverse events between groups. | 4 weeks |
| Safety Assessment | Change from baseline in HCT (L/L) | 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James J Leyden, MD | KGL, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGL, Inc | Broomall | Pennsylvania | 19008 | United States |
Not provided
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000709171 | berdazimer sodium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 4% NVN1000 Topical Gel | Drug | 4% NVN1000 4% Topical Gel applied once daily 4 weeks |
|
|
| 8% NVN1000 Topical Gel | Drug | 8% NVN1000 Topical Gel applied once daily for 4 weeks |
|
|
| Vehicle Topical Gel | Drug | Vehicle Topical Gel applied once daily |
|
|
| Safety Assessment | Change from baseline in HGB, MCHC (g/L) | 4 weeks |
| Safety Assessment | Change from baseline in % methemoglobin (%) | 4 weeks |
| Safety Assessment | Change from baseline in % Basophils (%) | 4 weeks |
| Safety Assessment | Change from baseline in % Eosinophils (%) | 4 weeks |
| Safety Assessment | Change from baseline in % Lymphocytes (%) | 4 weeks |
| Safety Assessment | Change from baseline in MCH (pg) | 4 weeks |
| Safety Assessment | Change from baseline in MCV, MPV (fL) | 4 weeks |
| Safety Assessment | Change from baseline in % Monocytes (%) | 4 weeks |
| Safety Assessment | Change from baseline in % Neutrophils (%) | 4 weeks |
| Safety Assessment | Change from baseline in Platelet Count, WBC (10 ^ 9/L) | 4 weeks |
| Safety Assessment | Change from baseline in % RDW (%) | 4 weeks |
| Safety Assessment | Change from baseline in RBC (10 ^ 12/L) | 4 weeks |
| Safety Assessment | Change from baseline in Albumin, Protein, Total (g/L) | 4 weeks |
| Safety Assessment | Change from baseline in Alkaline Phosphatase, ALT, AST, (U/L) | 4 weeks |
| Safety Assessment | Change from baseline in Bicarbonate, Bun, Calcium, Chloride, Glucose, Phosphorus, Potassium, Sodium (mmol/L) | 4 weeks |
| Safety Assessment | Change from baseline in Bilirubin Direct, Bilirubin Total, Creatinine (umol/ L) | 4 weeks |