A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: SB414 6%Drug: VehicleDrug: SB414 2%
- Registration Number
- NCT03431610
- Lead Sponsor
- Novan, Inc.
- Brief 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Male or female, 18 years of age and older, and in good general health;
- EASI score >1 and ≤21, involving ≥5% body surface area (BSA).
- Two target lesions at least 5 cm2 with a TLSS ≥5. Target lesions can not be located on the groin, hands, elbows, feet, ankles, knees, face or scalp.
- Willing to not use any other products for AD during the study;
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) prior to randomization and must agree to use an effective method of birth control during the study and for 30 days after their final study visit.
- Concurrent or recent use of topical or systemic medications without a sufficient washout period;
- Immunocompromised subjects including those who are known HIV positive or receiving current immunosuppressive treatment,
- Female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study;
- Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SB414 6% SB414 6% SB414 6% topically twice daily Vehicle Cream Vehicle Vehicle Cream topically twice daily SB414 2% SB414 2% SB414 2% topically twice daily
- Primary Outcome Measures
Name Time Method Plasma concentrations of hMAP3 Day 15 Peak plasma concentrations of hMAP3 after topical application of SB414
- Secondary Outcome Measures
Name Time Method Pharmacodynamics of SB414 Day 15 Change in relevant Pre and post dose tissue cytokine levels (mg/mg tissue)
Safety Profile (Reported Adverse Events) Day 15 Reported Adverse Events
Efficacy as assessed by EASI (Eczema area and severity index) score Screening, Baseline and Week 2 EASI Score will be collected
Investigator Assessment of Tolerability Baseline, Week 1 and Week 2 Investigator assessment of overall degree of irritation
Efficacy as assessed by Itch NRS Baseline, Week 1 and Week 2 Itching due to AD as reported by subject on an 11 point numerical rating scale
Subject Assessment of Tolerability Baseline, Week 1 and Week 2 Subject-reported from 5 point tolerability scale overall presence and degree of itching and burning / stinging
Efficacy as assessed by Target Lesion Severity Score Screening, Baseline, Week 1 and Week 2 Target Lesion Severity Score will be collected
Trial Locations
- Locations (9)
Novella Site# 242
🇺🇸Coral Gables, Florida, United States
Novella Site# 264
🇺🇸Sweetwater, Florida, United States
Novella Site# 250
🇺🇸Portland, Oregon, United States
Novella Site# 265
🇺🇸Hazleton, Pennsylvania, United States
Novells Site# 263
🇺🇸Pflugerville, Texas, United States
Novella Site# 114
🇺🇸Norfolk, Virginia, United States
Novella Site# 251
🇺🇸Indianapolis, Indiana, United States
Novella Site# 247
🇺🇸Boise, Idaho, United States
Novella Site# 201
🇺🇸Berlin, New Jersey, United States