NCT03431610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2018

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

January 31, 2018

Last Update Submit

September 6, 2018

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of hMAP3

    Peak plasma concentrations of hMAP3 after topical application of SB414

    Day 15

Secondary Outcomes (7)

  • Pharmacodynamics of SB414

    Day 15

  • Safety Profile (Reported Adverse Events)

    Day 15

  • Investigator Assessment of Tolerability

    Baseline, Week 1 and Week 2

  • Subject Assessment of Tolerability

    Baseline, Week 1 and Week 2

  • Efficacy as assessed by EASI (Eczema area and severity index) score

    Screening, Baseline and Week 2

  • +2 more secondary outcomes

Study Arms (3)

SB414 2%

EXPERIMENTAL

SB414 2% topically twice daily

Drug: SB414 2%

SB414 6%

EXPERIMENTAL

SB414 6% topically twice daily

Drug: SB414 6%

Vehicle Cream

PLACEBO COMPARATOR

Vehicle Cream topically twice daily

Drug: Vehicle

Interventions

SB414 2%DRUG

Twice daily

Also known as: NVN1000
SB414 2%
SB414 6%DRUG

Twice daily

Also known as: NVN1000
SB414 6%
VehicleDRUG

Placebo comparator

Also known as: Placebo
Vehicle Cream

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Novella Site# 242

Coral Gables, Florida, 33134, United States

Location

Novella Site# 264

Sweetwater, Florida, 33172, United States

Location

Novella Site# 247

Boise, Idaho, 83704, United States

Location

Novella Site# 251

Indianapolis, Indiana, 46256, United States

Location

Novella Site# 201

Berlin, New Jersey, 08009, United States

Location

Novella Site# 250

Portland, Oregon, 97210, United States

Location

Novella Site# 265

Hazleton, Pennsylvania, 18201, United States

Location

Novells Site# 263

Pflugerville, Texas, 78660, United States

Location

Novella Site# 114

Norfolk, Virginia, 23502, United States

Location

Related Publications (1)

  • 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.

    PMID: 32428543DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

berdazimer sodium

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Tomoko Maeda-Chubachi

    Novan, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 13, 2018

Study Start

November 13, 2017

Primary Completion

May 11, 2018

Study Completion

May 11, 2018

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations

US(9)