A 2 Period Cross-over Pharmacokinetic Study of SB204 in Acne Vulgaris
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|ClinicalTrials.gov Identifier: NCT02164084|
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : April 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: SB204 Drug: Vehicle Gel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1, Single-center, Double-blind, Randomized, Cross-over, Pharmacokinetics, Safety and Tolerability Study of SB204 8% (NVN1000 Gel) and Vehicle Gel|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||December 2014|
SB204 8% topically twice daily for 4 days and once on Day 5
SB204 Gel with hydrogel
Other Name: NVN1000
Placebo Comparator: Vehicle Gel
Vehicle Gel topically twice daily for 4 days and once on Day 5
Drug: Vehicle Gel
Vehicle Gel with hydrogel
- Pharmacokinetics of nitrate and silicon [ Time Frame: After single dose and multiple dose (Day 5) application ]Standard PK parameters including area under the curve (AUC) 0-∞, AUC0-t, Cmax, Cmin, and T1/2, for nitrate and silicon. Calculations may be based on actual and/or baseline-subtracted concentrations for nitrate.
- Safety [ Time Frame: Safety will be assessed throughout the study duration (up to 7 weeks). ]Physical examinations including vital signs, EKGs, and laboratory assessments (serum chemistry, hematology and urinalysis) will be performed at Screening and during the study. Adverse events will be collected throughout the study.
- Tolerability [ Time Frame: During both treatment periods, through last day of treatment. ]During the study, cutaneous tolerability assessments will be made at Day 1 and at the end of each treatment period (Day 5). Erythema, dryness, scaling, stinging/burning and itching will be assessed on a four point scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164084
|United States, Wisconsin|
|Spaulding Clinical Research, LLC|
|West Bend, Wisconsin, United States, 53095|
|Principal Investigator:||Carlos Sanabria, MD||Spaulding Clinical Research LLC|