Atopic Dermatitis
Conditions
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).
Interventions
Sponsors
Novella Clinical
Novan, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations of hMAP3 | Day 15 | Peak plasma concentrations of hMAP3 after topical application of SB414 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Profile (Reported Adverse Events) | Day 15 | Reported Adverse Events |
| Investigator Assessment of Tolerability | Baseline, Week 1 and Week 2 | Investigator assessment of overall degree of irritation |
| 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 |
| Pharmacodynamics of SB414 | Day 15 | Change in relevant Pre and post dose tissue cytokine levels (mg/mg tissue) |
| Efficacy as assessed by Target Lesion Severity Score | Screening, Baseline, Week 1 and Week 2 | Target Lesion Severity Score will be collected |
| 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 |
| Efficacy as assessed by EASI (Eczema area and severity index) score | Screening, Baseline and Week 2 | EASI Score will be collected |
Countries
United States
Outcome results
None listed