NCT03431610

A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis

A Phase 1b Multi-Center, Double-Blind, Randomized Vehicle-Controlled Study Assessing the PK , Pharmacodynamics, Safety and Tolerability of SB414 in Subjects With Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Novan, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.

Detailed description

This is a phase 1b, multi-center, randomized, double-blind, vehicle-controlled study to be conducted in approximately 48 non-immunocompromised adult subjects with mild to moderate AD. Subjects will be randomized to 2 active and 1 vehicle treatment arms. Subjects will apply the study drug (SB414 or Vehicle) to affected areas twice daily for 2 weeks (14 days).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	SB414 2%	Twice daily
DRUG	SB414 6%	Twice daily
DRUG	Vehicle	Placebo comparator

Timeline

• Start date: 2017-11-13
• Primary completion: 2018-05-11
• Completion: 2018-05-11
• First posted: 2018-02-13
• Last updated: 2018-09-07

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study