Acne VulgarisPhase 1NCT02164084
A 2 Period Cross-over Pharmacokinetic Study of SB204 in Acne Vulgaris
A Phase 1 study testing SB204 in people with Acne Vulgaris, run by Novan, Inc. at 1 site in United States.
Trial summary
This study will identify how much (if any) drug is absorbed from the skin of subjects with acne vulgaris after topical application of SB204. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- SB204
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects with an acne severity of moderate or severe and a minimum of 20 inflammatory and 20 non-inflammatory lesions on the face, trunk and shoulders
- 18 years of age and older
Who cannot join
- Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
- Subjects who smoke or use tobacco products
- Subjects with methemoglobin level greater than 2% at Screening or Baseline by pulse co-oximeter.
- Subjects with a previous history of methemoglobinemia
- Subjects being treated with nitrates or any drug associated with methemoglobinemia
- Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research, LLC
West Bend, Wisconsin, 53095
About this study
Official title: A Phase 1, Single-center, Double-blind, Randomized, Cross-over, Pharmacokinetics, Safety and Tolerability Study of SB204 8% (NVN1000 Gel) and Vehicle Gel
This study will identify how much (if any) drug is absorbed from the skin of subjects with acne vulgaris after topical application of SB204.
Read the detailed description
This is a single-center, double-blind, randomized, 2 period cross-over study to be conducted in 18 subjects (18 years of age and above) each of whom will receive SB204 8% and Vehicle Gel. Subjects who satisfy the entry criteria will be randomized to SB204 8% or Vehicle Gel in a 1:1 ratio for the first treatment period. Study drug will be applied to the face, upper chest, upper back and shoulders (approximately 17% BSA) twice daily on Days 1- 4 approximately 12 hours apart. On Day 5, the study drug will be applied to the same areas only once, in the morning. Pharmacokinetic (PK) profiling will be performed on Day 1 and Day 5. After a wash out period, subjects will be treated with the alternate product and undergo similar treatment and assessments. The primary assessment is the pharmacokinetic profile of nitrate and silicon as markers for systemic exposure to nitric oxide (nitrate) and NVN1000 (silicon) after topical application of SB204 8% to approximately 17% of the total body surface area.
- Conditions
- Acne Vulgaris
- Being tested
- SB204, Vehicle Gel
- Keywords
- acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB204Drug
Also called NVN1000
SB204 Gel with hydrogel
Vehicle GelDrug
Vehicle Gel with hydrogel
| Study group | Role | What they receive |
|---|---|---|
| SB204 | Experimental | SB204 8% topically twice daily for 4 days and once on Day 5 Receives: Drug: SB204 |
| Vehicle Gel | Placebo comparator | Vehicle Gel topically twice daily for 4 days and once on Day 5 Receives: Drug: Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of nitrate and silicon
Standard PK parameters including area under the curve (AUC) 0-∞, AUC0-t, Cmax, Cmin, and T1/2, for nitrate and silicon. Calculations may be based on actual and/or baseline-subtracted concentrations for nitrate.
Measured: After single dose and multiple dose (Day 5) application
Secondary outcomes (1)
Safety
Physical examinations including vital signs, EKGs, and laboratory assessments (serum chemistry, hematology and urinalysis) will be performed at Screening and during the study. Adverse events will be collected throughout the study.
Measured: Safety will be assessed throughout the study duration (up to 7 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2014
- Study completionDec 2014
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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Sanabria, MD, Principal investigator, Spaulding Clinical Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164084
- Sponsor's protocol ID
- NI-AC101
- Status last verified
- Apr 2015
- First submitted
- 12 Jun 2014
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Double-blind, Randomized, Cross-over, Pharmacokinetics, Safety and Tolerability Study of SB204 8% (NVN1000 Gel) and Vehicle Gel
- ClinicalTrials.gov ID
- NCT02164084
- Acronym / sponsor ID
- NI-AC101
- Conditions
- Acne Vulgaris
- Keywords
- acne
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Jun 2014 (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.
This study will identify how much (if any) drug is absorbed from the skin of subjects with acne vulgaris after topical application of SB204.
Detailed description
This is a single-center, double-blind, randomized, 2 period cross-over study to be conducted in 18 subjects (18 years of age and above) each of whom will receive SB204 8% and Vehicle Gel. Subjects who satisfy the entry criteria will be randomized to SB204 8% or Vehicle Gel in a 1:1 ratio for the first treatment period. Study drug will be applied to the face, upper chest, upper back and shoulders (approximately 17% BSA) twice daily on Days 1- 4 approximately 12 hours apart. On Day 5, the study drug will be applied to the same areas only once, in the morning. Pharmacokinetic (PK) profiling will be performed on Day 1 and Day 5. After a wash out period, subjects will be treated with the alternate product and undergo similar treatment and assessments. The primary assessment is the pharmacokinetic profile of nitrate and silicon as markers for systemic exposure to nitric oxide (nitrate) and NVN1000 (silicon) after topical application of SB204 8% to approximately 17% of the total body surface area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB204 | Experimental | Drug: SB204SB204 8% topically twice daily for 4 days and once on Day 5 |
| Vehicle Gel | Placebo comparator | Drug: Vehicle GelVehicle Gel topically twice daily for 4 days and once on Day 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female subjects with an acne severity of moderate or severe and a minimum of 20 inflammatory and 20 non-inflammatory lesions on the face, trunk and shoulders
- 18 years of age and older
Key exclusion criteria (6 listed)
- Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
- Subjects who smoke or use tobacco products
- Subjects with methemoglobin level greater than 2% at Screening or Baseline by pulse co-oximeter.
- Subjects with a previous history of methemoglobinemia
- Subjects being treated with nitrates or any drug associated with methemoglobinemia
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 |
|---|---|---|
| SB204Also: NVN1000SB204 Gel with hydrogel | Drug | SB204 |
| Vehicle GelVehicle Gel with hydrogel | Drug | Vehicle Gel |
Primary outcome
Pharmacokinetics of nitrate and silicon
Time frame: After single dose and multiple dose (Day 5) application
Standard PK parameters including area under the curve (AUC) 0-∞, AUC0-t, Cmax, Cmin, and T1/2, for nitrate and silicon. Calculations may be based on actual and/or baseline-subtracted concentrations for nitrate.
1 secondary outcome
Safety
Time frame: Safety will be assessed throughout the study duration (up to 7 weeks).
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 3 Apr 2015.
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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.
Carlos Sanabria, MD principal investigator
Spaulding Clinical Research LLC
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 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 2 inclusion and 6 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 3 Apr 2015. 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. 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?
Pharmacokinetics of nitrate and silicon (time frame: After single dose and multiple dose (Day 5) application). 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 3 Apr 2015.