Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-01-02 @ 9:43 AM
Study NCT ID:
NCT02801903
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2016-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris
Sponsor:
Novan, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Single-center, Open-label Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents With Moderate to Severe Acne Vulgaris
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: