Back to resultsPharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SB204 4%
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Otherwise healthy male and female adolescent subjects with moderate to severe acne vulgaris on a 5 point IGA scale
- At least 20 total inflammatory lesions (papules and pustules), and at least 20 total non-inflammatory lesions (open and closed comedones) on the face, chest, back, and shoulders
- Age 9-16 years, 11 months inclusive
- Subjects with methemoglobin level less than 3% at Screening and Baseline by pulse co-oximeter
Exclusion Criteria:
- Subjects with any other acne-like dermatological conditions such as severe, recalcitrant nodulocystic acne, acne conglobata, acne fulminans, acne secondary to medications or other medical conditions, perioral dermatitis, clinically significant rosacea, or gram-negative folliculitis;
- Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
- Subjects who reside in a dwelling that relies on well water for a primary drinking source
- Subjects with facial hair (beards, mustaches, etc.), tattoos or other facial markings that would interfere with assessments and study drug application
- Transgender subjects receiving hormone supplement (male to female or female to male)
- Subjects with a previous history of methemoglobinemia or taking medications known to be associated with methemoglobinemia
- Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens
- Females who are pregnant, planning a pregnancy or breastfeeding
- Subjects previously treated with NVN1000 Gel / SB204
Sites / Locations
- WCCT #1
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SB204 4%
Arm Description
Topically Once Daily (AM)
Outcomes
Primary Outcome Measures
Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration
Maximum plasma concentration of plasma hMAP3 on Day 21
AUC - area under the plasma concentration time curve for hMAP3
AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma hMAP3 on Day 21
Secondary Outcome Measures
Pharmacokinetics as measured by maximum concentration of nitrate
Cmax: maximum plasma concentration of plasma nitrate on Day 21
Pharmacokinetics (AUC) - area under the plasma concentration time curve for hMAP3
AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma nitrate on Day 21
Safety profile (Reported adverse events)
Reported adverse events
Tolerability (Scores on tolerability assessment)
Scores on tolerability assessment during treatment
Full Information
NCT ID
NCT02801903
First Posted
June 9, 2016
Last Updated
October 10, 2018
Sponsor
Novan, Inc.
Collaborators
WCCT Global
1. Study Identification
Unique Protocol Identification Number
NCT02801903
Brief Title
Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris
Official Title
A Phase 1, Single-center, Open-label Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents With Moderate to Severe Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 7, 2016 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 25, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novan, Inc.
Collaborators
WCCT Global
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents with Moderate to Severe Acne Vulgaris
Detailed Description
This is a single-center, open-label study to be conducted in 18 otherwise healthy adolescents with moderate to severe acne vulgaris. Repeat blood samples will be obtained on Day 1 and Day 21 pre and post treatment to characterize systemic exposure to hMAP3 and nitrate. Subjects will receive a low-nitrate diet for 12 hours prior to and during the PK sampling period
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SB204 4%
Arm Type
Experimental
Arm Description
Topically Once Daily (AM)
Intervention Type
Drug
Intervention Name(s)
SB204 4%
Other Intervention Name(s)
NVN1000
Intervention Description
Topically Once Daily (AM)
Primary Outcome Measure Information:
Title
Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration
Description
Maximum plasma concentration of plasma hMAP3 on Day 21
Time Frame
Day 21
Title
AUC - area under the plasma concentration time curve for hMAP3
Description
AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma hMAP3 on Day 21
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
Pharmacokinetics as measured by maximum concentration of nitrate
Description
Cmax: maximum plasma concentration of plasma nitrate on Day 21
Time Frame
Day 21
Title
Pharmacokinetics (AUC) - area under the plasma concentration time curve for hMAP3
Description
AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma nitrate on Day 21
Time Frame
Day 21
Title
Safety profile (Reported adverse events)
Description
Reported adverse events
Time Frame
Day 21/End of Treatment
Title
Tolerability (Scores on tolerability assessment)
Description
Scores on tolerability assessment during treatment
Time Frame
Day 21/End of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Otherwise healthy male and female adolescent subjects with moderate to severe acne vulgaris on a 5 point IGA scale
At least 20 total inflammatory lesions (papules and pustules), and at least 20 total non-inflammatory lesions (open and closed comedones) on the face, chest, back, and shoulders
Age 9-16 years, 11 months inclusive
Subjects with methemoglobin level less than 3% at Screening and Baseline by pulse co-oximeter
Exclusion Criteria:
Subjects with any other acne-like dermatological conditions such as severe, recalcitrant nodulocystic acne, acne conglobata, acne fulminans, acne secondary to medications or other medical conditions, perioral dermatitis, clinically significant rosacea, or gram-negative folliculitis;
Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
Subjects who reside in a dwelling that relies on well water for a primary drinking source
Subjects with facial hair (beards, mustaches, etc.), tattoos or other facial markings that would interfere with assessments and study drug application
Transgender subjects receiving hormone supplement (male to female or female to male)
Subjects with a previous history of methemoglobinemia or taking medications known to be associated with methemoglobinemia
Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens
Females who are pregnant, planning a pregnancy or breastfeeding
Subjects previously treated with NVN1000 Gel / SB204
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Joyce Rico, MD
Organizational Affiliation
Novan, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
WCCT #1
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris
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