Pharmacokinetics of Topical SB204 in Adolescents With Acn... | NCT02801903

Studies
Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris

NCT02801903

Sponsor

Novan, Inc.

Status

Completed

Last Update Posted

Oct 12, 2018Actual

Enrollment

18Actual

Phase

Phase 1

Conditions

Acne Vulgaris

Interventions

SB204 4%

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 7, 2016Actual

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 25, 2016Actual

First Submitted Date

Jun 9, 2016

First Submission Date that Met QC Criteria

Jun 13, 2016

First Posted Date

Jun 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2018

Last Update Posted Date

Oct 12, 2018Actual

Name	Class
WCCT Global	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Label	Type	Description	Intervention Names
SB204 4%	Experimental	Topically Once Daily (AM)	Drug: SB204 4%

Name	Type	Description	Arm Group Labels	Other Names
SB204 4%	Drug	Topically Once Daily (AM)	SB204 4%	NVN1000

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration	Maximum plasma concentration of plasma hMAP3 on Day 21	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	Day 21

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics as measured by maximum concentration of nitrate	Cmax: maximum plasma concentration of plasma nitrate on Day 21	Day 21
Pharmacokinetics (AUC) - area under the plasma concentration time curve for hMAP3

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases