Acne VulgarisPhase 1NCT02801903
Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris
A Phase 1 study testing SB204 4% in people with Acne Vulgaris, run by Novan, Inc. at 1 site in United States.
Trial summary
A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents with Moderate to Severe Acne Vulgaris Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- SB204 4%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2016to 25 Aug 2016
- 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 9 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Otherwise healthy male and female adolescent subjects with moderate to severe acne vulgaris on a 5 point IGA scale
- At least 20 total inflammatory lesions (papules and pustules), and at least 20 total non-inflammatory lesions (open and closed comedones) on the face, chest, back, and shoulders
- Age 9-16 years, 11 months inclusive
- Subjects with methemoglobin level less than 3% at Screening and Baseline by pulse co-oximeter
Who cannot join
- Subjects with any other acne-like dermatological conditions such as severe, recalcitrant nodulocystic acne, acne conglobata, acne fulminans, acne secondary to medications or other medical conditions, perioral dermatitis, clinically significant rosacea, or gram-negative folliculitis;
- Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
- Subjects who reside in a dwelling that relies on well water for a primary drinking source
- Subjects with facial hair (beards, mustaches, etc.), tattoos or other facial markings that would interfere with assessments and study drug application
- Transgender subjects receiving hormone supplement (male to female or female to male)
- Subjects with a previous history of methemoglobinemia or taking medications known to be associated with methemoglobinemia
Show all 9Show fewer
- Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens
- Females who are pregnant, planning a pregnancy or breastfeeding
- Subjects previously treated with NVN1000 Gel / SB204
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-center, Open-label Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents With Moderate to Severe Acne Vulgaris
A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents with Moderate to Severe Acne Vulgaris
Read the detailed description
This is a single-center, open-label study to be conducted in 18 otherwise healthy adolescents with moderate to severe acne vulgaris. Repeat blood samples will be obtained on Day 1 and Day 21 pre and post treatment to characterize systemic exposure to hMAP3 and nitrate. Subjects will receive a low-nitrate diet for 12 hours prior to and during the PK sampling period
- Conditions
- Acne Vulgaris
- Being tested
- SB204 4%
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB204 4%Drug
Also called NVN1000
Topically Once Daily (AM)
| Study group | Role | What they receive |
|---|---|---|
| SB204 4% | Experimental | Topically Once Daily (AM) Receives: Drug: SB204 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration
Maximum plasma concentration of plasma hMAP3 on Day 21
Measured: Day 21
AUC - area under the plasma concentration time curve for hMAP3
AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma hMAP3 on Day 21
Measured: Day 21
Secondary outcomes (4)
Pharmacokinetics as measured by maximum concentration of nitrate
Cmax: maximum plasma concentration of plasma nitrate on Day 21
Measured: Day 21
Pharmacokinetics (AUC) - area under the plasma concentration time curve for hMAP3
AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma nitrate on Day 21
Measured: Day 21
Safety profile (Reported adverse events)
Reported adverse events
Measured: Day 21/End of Treatment
Tolerability (Scores on tolerability assessment)
Scores on tolerability assessment during treatment
Measured: Day 21/End of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start7 Jun 2016
- Primary completionAug 2016
- Study completion25 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WCCT Global
- Responsible party
- Sponsor
- Investigators
- M. Joyce Rico, MD, Study director, Novan, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801903
- Sponsor's protocol ID
- NI-AC103
- Status last verified
- Oct 2018
- First submitted
- 9 Jun 2016
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Open-label Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents With Moderate to Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02801903
- Acronym / sponsor ID
- NI-AC103
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- WCCT Global
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- 25 Aug 2016 (actual)
- First posted
- 16 Jun 2016 (estimated)
- 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.
A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents with Moderate to Severe Acne Vulgaris
Detailed description
This is a single-center, open-label study to be conducted in 18 otherwise healthy adolescents with moderate to severe acne vulgaris. Repeat blood samples will be obtained on Day 1 and Day 21 pre and post treatment to characterize systemic exposure to hMAP3 and nitrate. Subjects will receive a low-nitrate diet for 12 hours prior to and during the PK sampling period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SB204 4% | Experimental | Drug: SB204 4%Topically Once Daily (AM) |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Otherwise healthy male and female adolescent subjects with moderate to severe acne vulgaris on a 5 point IGA scale
- At least 20 total inflammatory lesions (papules and pustules), and at least 20 total non-inflammatory lesions (open and closed comedones) on the face, chest, back, and shoulders
- Age 9-16 years, 11 months inclusive
- Subjects with methemoglobin level less than 3% at Screening and Baseline by pulse co-oximeter
Key exclusion criteria (9 listed)
- Subjects with any other acne-like dermatological conditions such as severe, recalcitrant nodulocystic acne, acne conglobata, acne fulminans, acne secondary to medications or other medical conditions, perioral dermatitis, clinically significant rosacea, or gram-negative folliculitis;
- Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
- Subjects who reside in a dwelling that relies on well water for a primary drinking source
- Subjects with facial hair (beards, mustaches, etc.), tattoos or other facial markings that would interfere with assessments and study drug application
- Transgender subjects receiving hormone supplement (male to female or female to male)
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 |
|---|---|---|
| SB204 4%Also: NVN1000Topically Once Daily (AM) | Drug | SB204 4% |
Primary outcome
Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration
Time frame: Day 21
Maximum plasma concentration of plasma hMAP3 on Day 21
AUC - area under the plasma concentration time curve for hMAP3
Time frame: Day 21
AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma hMAP3 on Day 21
4 secondary outcomes
Pharmacokinetics as measured by maximum concentration of nitrate
Time frame: Day 21
Pharmacokinetics (AUC) - area under the plasma concentration time curve for hMAP3
Time frame: Day 21
Safety profile (Reported adverse events)
Time frame: Day 21/End of Treatment
Tolerability (Scores on tolerability assessment)
Time frame: Day 21/End of treatment
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 12 Oct 2018.
- Individual participant dataSharing planned: No
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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.
M. Joyce Rico, MD study director
Novan, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SB204 4% in people with Acne Vulgaris, run by Novan, Inc. at 1 site 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 4 inclusion and 9 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 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration (time frame: Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2018.