A 2 Period Cross-over Pharmacokinetic Study of SB204 in Acne Vulgaris
A Phase 1, Single-center, Double-blind, Randomized, Cross-over, Pharmacokinetics, Safety and Tolerability Study of SB204 8% (NVN1000 Gel) and Vehicle Gel
1 other identifier
interventional
18
1 country
1
Brief Summary
This study will identify how much (if any) drug is absorbed from the skin of subjects with acne vulgaris after topical application of SB204.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 12, 2014
CompletedFirst Posted
Study publicly available on registry
June 16, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 3, 2015
April 1, 2015
Same day
June 12, 2014
April 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics of nitrate and silicon
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.
After single dose and multiple dose (Day 5) application
Secondary Outcomes (1)
Safety
Safety will be assessed throughout the study duration (up to 7 weeks).
Other Outcomes (1)
Tolerability
During both treatment periods, through last day of treatment.
Study Arms (2)
SB204
EXPERIMENTALSB204 8% topically twice daily for 4 days and once on Day 5
Vehicle Gel
PLACEBO COMPARATORVehicle Gel topically twice daily for 4 days and once on Day 5
Interventions
Eligibility Criteria
You may qualify if:
- Male and female subjects with an acne severity of moderate or severe and a minimum of 20 inflammatory and 20 non-inflammatory lesions on the face, trunk and shoulders
- years of age and older
You may not qualify if:
- Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
- Subjects who smoke or use tobacco products
- Subjects with methemoglobin level greater than 2% at Screening or Baseline by pulse co-oximeter.
- Subjects with a previous history of methemoglobinemia
- Subjects being treated with nitrates or any drug associated with methemoglobinemia
- Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novan, Inc.lead
Study Sites (1)
Spaulding Clinical Research, LLC
West Bend, Wisconsin, 53095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Sanabria, MD
Spaulding Clinical Research LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2014
First Posted
June 16, 2014
Study Start
June 1, 2014
Primary Completion
June 1, 2014
Study Completion
December 1, 2014
Last Updated
April 3, 2015
Record last verified: 2015-04