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| Name | Class |
|---|---|
| Novella Clinical | OTHER |
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This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB414 2% | Experimental | SB414 2% topically twice daily |
|
| SB414 6% | Experimental | SB414 6% topically twice daily |
|
| Vehicle Cream | Placebo Comparator | Vehicle Cream topically twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB414 2% | Drug | Twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of hMAP3 | Peak plasma concentrations of hMAP3 after topical application of SB414 | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics of SB414 | Change in relevant Pre and post dose tissue cytokine levels (mg/mg tissue) | Day 15 |
| Safety Profile (Reported Adverse Events) | Reported Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomoko Maeda-Chubachi | Novan, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novella Site# 242 | Coral Gables | Florida | 33134 | United States | ||
| Novella Site# 264 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32428543 | Derived | Guttman-Yassky E, Gallo RL, Pavel AB, Nakatsuji T, Li R, Zhang N, Messersmith E, Maeda-Chubachi T. A Nitric Oxide-Releasing Topical Medication as a Potential Treatment Option for Atopic Dermatitis through Antimicrobial and Anti-Inflammatory Activity. J Invest Dermatol. 2020 Dec;140(12):2531-2535.e2. doi: 10.1016/j.jid.2020.04.013. Epub 2020 May 16. No abstract available. |
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| SB414 6% |
| Drug |
Twice daily |
|
|
| Vehicle | Drug | Placebo comparator |
|
|
| Day 15 |
| Investigator Assessment of Tolerability | Investigator assessment of overall degree of irritation | Baseline, Week 1 and Week 2 |
| Subject Assessment of Tolerability | Subject-reported from 5 point tolerability scale overall presence and degree of itching and burning / stinging | Baseline, Week 1 and Week 2 |
| Efficacy as assessed by EASI (Eczema area and severity index) score | EASI Score will be collected | Screening, Baseline and Week 2 |
| Efficacy as assessed by Target Lesion Severity Score | Target Lesion Severity Score will be collected | Screening, Baseline, Week 1 and Week 2 |
| Efficacy as assessed by Itch NRS | Itching due to AD as reported by subject on an 11 point numerical rating scale | Baseline, Week 1 and Week 2 |
| Sweetwater |
| Florida |
| 33172 |
| United States |
| Novella Site# 247 | Boise | Idaho | 83704 | United States |
| Novella Site# 251 | Indianapolis | Indiana | 46256 | United States |
| Novella Site# 201 | Berlin | New Jersey | 08009 | United States |
| Novella Site# 250 | Portland | Oregon | 97210 | United States |
| Novella Site# 265 | Hazleton | Pennsylvania | 18201 | United States |
| Novells Site# 263 | Pflugerville | Texas | 78660 | United States |
| Novella Site# 114 | Norfolk | Virginia | 23502 | United States |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000709171 | berdazimer sodium |
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