Acne VulgarisPhase 1NCT01755247
A Phase 1, 3 Day Study of Safety and Tolerability of NVN1000 Topical Gel in Healthy Volunteers
A Phase 1 study testing 8% NVN1000 Topical Gel and 8% NVN1000 Topical Gel and moisturizer in people with Acne Vulgaris, run by Novan, Inc. at 1 site in United States.
Trial summary
A Phase I, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- 8% NVN1000 Topical Gel and 8% NVN1000 Topical Gel and moisturizer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Dec 2012
- 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
- Healthy Male and Females > 18 years of age
- High degree of fluorescence of facial skin under Wood's lamp
Who cannot join
- Acute or chronic skin disorders
- Topical or systemic antibiotics within 4 weeks of study enrollment
- Use of medication that increases risk of methemoglobinemia or influences P. acnes counts
- Subjects with medical illnesses, anemia, elevated methemoglobin
- Women who are pregnant, nursing or planning a pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase One, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN10000 Topical Gel in Healthy Volunteers
A Phase I, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers
Read the detailed description
This is a 3 day study to assess safety and tolerability of a new topical gel product, NVN1000 with and without the application of a commercially available moisturizer in approximately 15 healthy subjects. The test product will be applied to the forehead of healthy volunteers once daily for 3 days. One group of subjects will have a moisturizer applied to the same area 15 minutes after the test gel was applied and one group of subjects will be treated with the gel vehicle which does not contain the active product. The hypothesis is that the application of moisturizer will not effect safety or local tolerability.
- Conditions
- Acne Vulgaris
- Being tested
- Topical Gel Vehicle, 8% NVN1000 Topical Gel, 8% NVN1000 Topical Gel and moisturizer
- 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.
Topical Gel VehicleDrug
Also called Vehicle
8% NVN1000 Topical GelDrug
Also called NVN1000 Topical Gel
8% NVN1000 Topical Gel and moisturizerDrug
Also called NVN1000 plus moisturizer
| Study group | Role | What they receive |
|---|---|---|
| Topical Gel Vehicle | Placebo comparator | Once daily application of topical gel vehicle to forehead for 3 days Receives: Drug: Topical Gel Vehicle |
| 8% NVN1000 Topical Gel | Active comparator | Once daily application of 8% NVN1000 Topical Gel to the forehead for 3 days Receives: Drug: 8% NVN1000 Topical Gel |
| 8% NVN1000 Topical Gel and moisturizer | Active comparator | Once daily application of 8% NVN1000 Topical Gel to the forehead, followed 15 minutes later by application of a commercially available moisturizer Receives: Drug: 8% NVN1000 Topical Gel and moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous tolerability
Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging.
Measured: 3 days
Secondary outcomes (1)
Safety comparison
Assess safety through the comparison of adverse events between groups (lab assessments, physical exams and vital signs).
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2012
- Study completionDec 2012
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James J Leyden, Principal investigator, KGL, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755247
- Sponsor's protocol ID
- NI-AC004
- Status last verified
- May 2019
- First submitted
- 18 Dec 2012
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase One, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN10000 Topical Gel in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01755247
- Acronym / sponsor ID
- NI-AC004
- Conditions
- Acne Vulgaris
- Keywords
- acne
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Dec 2012 (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 I, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers
Detailed description
This is a 3 day study to assess safety and tolerability of a new topical gel product, NVN1000 with and without the application of a commercially available moisturizer in approximately 15 healthy subjects. The test product will be applied to the forehead of healthy volunteers once daily for 3 days. One group of subjects will have a moisturizer applied to the same area 15 minutes after the test gel was applied and one group of subjects will be treated with the gel vehicle which does not contain the active product. The hypothesis is that the application of moisturizer will not effect safety or local tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical Gel Vehicle | Placebo comparator | Drug: Topical Gel VehicleOnce daily application of topical gel vehicle to forehead for 3 days |
| 8% NVN1000 Topical Gel | Active comparator | Drug: 8% NVN1000 Topical GelOnce daily application of 8% NVN1000 Topical Gel to the forehead for 3 days |
| 8% NVN1000 Topical Gel and moisturizer | Active comparator | Drug: 8% NVN1000 Topical Gel and moisturizerOnce daily application of 8% NVN1000 Topical Gel to the forehead, followed 15 minutes later by application of a commercially available moisturizer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Male and Females > 18 years of age
- High degree of fluorescence of facial skin under Wood's lamp
Key exclusion criteria (5 listed)
- Acute or chronic skin disorders
- Topical or systemic antibiotics within 4 weeks of study enrollment
- Use of medication that increases risk of methemoglobinemia or influences P. acnes counts
- Subjects with medical illnesses, anemia, elevated methemoglobin
- Women who are pregnant, nursing or planning a pregnancy
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 |
|---|---|---|
| Topical Gel VehicleAlso: Vehicle | Drug | Topical Gel Vehicle |
| 8% NVN1000 Topical GelAlso: NVN1000 Topical Gel | Drug | 8% NVN1000 Topical Gel |
| 8% NVN1000 Topical Gel and moisturizerAlso: NVN1000 plus moisturizer | Drug | 8% NVN1000 Topical Gel and moisturizer |
Primary outcome
Cutaneous tolerability
Time frame: 3 days
Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging.
1 secondary outcome
Safety comparison
Time frame: 3 Days
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 10 Sep 2019.
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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.
James J Leyden principal investigator
KGL, 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 8% NVN1000 Topical Gel and 8% NVN1000 Topical Gel and moisturizer 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 5 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 10 Sep 2019. 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?
Cutaneous tolerability (time frame: 3 days). 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 10 Sep 2019.