Atopic DermatitisPhase 1NCT03431610
A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis
A Phase 1 study testing SB414 2% and SB414 6% in people with Atopic Dermatitis, run by Novan, Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- SB414 2% and SB414 6%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 9 sitesUnited States
- Study dates
- 13 Nov 2017to 11 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Novella Site# 201
Berlin, New Jersey, 08009
Novella Site# 247
Boise, Idaho, 83704
Novella Site# 242
Coral Gables, Florida, 33134
Novella Site# 265
Hazleton, Pennsylvania, 18201
Novella Site# 251
Indianapolis, Indiana, 46256
Novella Site# 114
Norfolk, Virginia, 23502
Novells Site# 263
Pflugerville, Texas, 78660
Novella Site# 250
Portland, Oregon, 97210
Novella Site# 264
Sweetwater, Florida, 33172
About this study
Official title: 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
This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.
Read the 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
- Being tested
- SB414 2%, SB414 6%, Vehicle
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB414 2%Drug
Also called NVN1000
Twice daily
SB414 6%Drug
Also called NVN1000
Twice daily
VehicleDrug
Also called Placebo
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| SB414 2% | Experimental | SB414 2% topically twice daily Receives: Drug: SB414 2% |
| SB414 6% | Experimental | SB414 6% topically twice daily Receives: Drug: SB414 6% |
| Vehicle Cream | Placebo comparator | Vehicle Cream topically twice daily Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of hMAP3
Peak plasma concentrations of hMAP3 after topical application of SB414
Measured: Day 15
Secondary outcomes (7)
Pharmacodynamics of SB414
Change in relevant Pre and post dose tissue cytokine levels (mg/mg tissue)
Measured: Day 15
Safety Profile (Reported Adverse Events)
Reported Adverse Events
Measured: Day 15
Investigator Assessment of Tolerability
Investigator assessment of overall degree of irritation
Measured: 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
Measured: Baseline, Week 1 and Week 2
Efficacy as assessed by EASI (Eczema area and severity index) score
EASI Score will be collected
Measured: Screening, Baseline and Week 2
Efficacy as assessed by Target Lesion Severity Score
Target Lesion Severity Score will be collected
Measured: 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
Measured: Baseline, Week 1 and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start13 Nov 2017
- Primary completion11 May 2018
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novella Clinical
- Responsible party
- Sponsor
- Investigators
- Tomoko Maeda-Chubachi, Study chair, Novan, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431610
- Sponsor's protocol ID
- NI-AD101
- Status last verified
- Sep 2018
- First submitted
- 31 Jan 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 32428543
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03431610
- Acronym / sponsor ID
- NI-AD101
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novella Clinical
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SB414 2% | Experimental | Drug: SB414 2%SB414 2% topically twice daily |
| SB414 6% | Experimental | Drug: SB414 6%SB414 6% topically twice daily |
| Vehicle Cream | Placebo comparator | Drug: VehicleVehicle Cream topically twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB414 2%Also: NVN1000Twice daily | Drug | SB414 2% |
| SB414 6%Also: NVN1000Twice daily | Drug | SB414 6% |
| VehicleAlso: PlaceboPlacebo comparator | Drug | Vehicle Cream |
Primary outcome
Plasma concentrations of hMAP3
Time frame: Day 15
Peak plasma concentrations of hMAP3 after topical application of SB414
7 secondary outcomes
Pharmacodynamics of SB414
Time frame: Day 15
Safety Profile (Reported Adverse Events)
Time frame: Day 15
Investigator Assessment of Tolerability
Time frame: Baseline, Week 1 and Week 2
Subject Assessment of Tolerability
Time frame: Baseline, Week 1 and Week 2
Efficacy as assessed by EASI (Eczema area and severity index) score
Time frame: Screening, Baseline and Week 2
Efficacy as assessed by Target Lesion Severity Score
Time frame: Screening, Baseline, Week 1 and Week 2
Efficacy as assessed by Itch NRS
Time frame: Baseline, Week 1 and Week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Derived from this study: PubMed 32428543Guttman-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomoko Maeda-Chubachi study chair
Novan, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SB414 2% and SB414 6% in people with Atopic Dermatitis, run by Novan, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of hMAP3 (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03431610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.