Tinea PedisPhase 2NCT02860052
SB208 for the Treatment of Tinea Pedis
A Phase 2 study testing SB208 2%, SB208 4% and SB208 16% in people with Tinea Pedis, run by Novan, Inc. at 1 site in Dominican Republic.
Trial summary
This is a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in non immunocompromised adult subjects with interdigital tinea pedis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- SB208 2%, SB208 4% and SB208 16%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 1 siteDominican Republic
- Study dates
- 19 Jul 2016to 1 Feb 2017
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Otherwise healthy male and female subjects with clinical diagnosis of interdigital t. pedis
- T.pedis provisionally confirmed at baseline by a positive KOH wet mount for segmented fungal hyphae on skin scraping from the target site
Who cannot join
- Women who are pregnant or nursing or planning on becoming pregnant
- Subjects with onychomycosis or moccasin-type t. pedis
- Subjects using topical or systemic anti-fungal agents
Trial locations and contacts
1 site in 1 country.
Dominican Republic1 site
Instituto Dermatológico y Cirugía de Piel,
Santo Domingo
About this study
Official title: A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Ranging Study Assessing Efficacy and Safety of SB208 and Vehicle Gel in Subjects With Interdigital Tinea Pedis
This is a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in non immunocompromised adult subjects with interdigital tinea pedis.
Read the detailed description
A phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in approximately 170 non immunocompromised adult subjects with interdigital tinea pedis. Subjects will apply the investigational product (IP) (SB208 or Vehicle Gel) to the interdigital areas and all affected and immediate surrounding areas of one or both feet once daily for 2 weeks, followed by a 4-week post-treatment observation period.
- Conditions
- Tinea Pedis
- Being tested
- SB208 2%, SB208 4%, SB208 16%, Vehicle Gel
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB208 2%Drug
Also called NVN1000 4%
Apply once daily to one or both feet for 14 days
SB208 4%Drug
Also called NVN1000 8%
Apply once daily to one or both feet for 14 days
SB208 16%Drug
Also called NVN1000 32%
Apply once daily to one or both feet for 14 days
Vehicle GelDrug
Also called Vehicle
Apply once daily to one or both feet for 14 days
| Study group | Role | What they receive |
|---|---|---|
| SB208 2% | Experimental | Apply once daily to one or both feet for 14 days Receives: Drug: SB208 2% |
| SB208 4% | Experimental | Apply once daily to one or both feet for 14 days Receives: Drug: SB208 4% |
| SB208 16% | Experimental | Apply once daily to one or both feet for 14 days Receives: Drug: SB208 16% |
| Vehicle Gel | Placebo comparator | Apply once daily to one or both feet for 14 days Receives: Drug: Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fungal culture result
Negative fungal culture from target lesion
Measured: 2 weeks
Secondary outcomes (2)
Clinical cure
Amelioration of signs and symptoms of tinea pedis
Measured: 6 wks
Mycological cure
No evidence of fungal infection based on skin scraping and culture
Measured: 6 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start19 Jul 2016
- Primary completionJan 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea PedisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M Joyce Rico, MD, Study director, Novan, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860052
- Sponsor's protocol ID
- NI-AF201
- Status last verified
- Nov 2018
- First submitted
- 2 Aug 2016
- Last updated
- 10 Jan 2019
- 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 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Ranging Study Assessing Efficacy and Safety of SB208 and Vehicle Gel in Subjects With Interdigital Tinea Pedis
- ClinicalTrials.gov ID
- NCT02860052
- Acronym / sponsor ID
- NI-AF201
- Conditions
- Tinea Pedis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 9 Aug 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.
This is a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in non immunocompromised adult subjects with interdigital tinea pedis.
Detailed description
A phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in approximately 170 non immunocompromised adult subjects with interdigital tinea pedis. Subjects will apply the investigational product (IP) (SB208 or Vehicle Gel) to the interdigital areas and all affected and immediate surrounding areas of one or both feet once daily for 2 weeks, followed by a 4-week post-treatment observation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SB208 2% | Experimental | Drug: SB208 2%Apply once daily to one or both feet for 14 days |
| SB208 4% | Experimental | Drug: SB208 4%Apply once daily to one or both feet for 14 days |
| SB208 16% | Experimental | Drug: SB208 16%Apply once daily to one or both feet for 14 days |
| Vehicle Gel | Placebo comparator | Drug: Vehicle GelApply once daily to one or both feet for 14 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Otherwise healthy male and female subjects with clinical diagnosis of interdigital t. pedis
- T.pedis provisionally confirmed at baseline by a positive KOH wet mount for segmented fungal hyphae on skin scraping from the target site
Key exclusion criteria (3 listed)
- Women who are pregnant or nursing or planning on becoming pregnant
- Subjects with onychomycosis or moccasin-type t. pedis
- Subjects using topical or systemic anti-fungal agents
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 |
|---|---|---|
| SB208 2%Also: NVN1000 4%Apply once daily to one or both feet for 14 days | Drug | SB208 2% |
| SB208 4%Also: NVN1000 8%Apply once daily to one or both feet for 14 days | Drug | SB208 4% |
| SB208 16%Also: NVN1000 32%Apply once daily to one or both feet for 14 days | Drug | SB208 16% |
| Vehicle GelAlso: VehicleApply once daily to one or both feet for 14 days | Drug | Vehicle Gel |
Primary outcome
Fungal culture result
Time frame: 2 weeks
Negative fungal culture from target lesion
2 secondary outcomes
Clinical cure
Time frame: 6 wks
Mycological cure
Time frame: 6 wks
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 Jan 2019.
- 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 2 study testing SB208 2%, SB208 4% and SB208 16% in people with Tinea Pedis, run by Novan, Inc. at 1 site in Dominican Republic.
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 3 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 Jan 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 Dominican Republic. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Fungal culture result (time frame: 2 weeks). 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 Jan 2019.