Genital WartsPhase 2NCT02462187
Topical NVN1000 for the Treatment of External Genital and Perianal Warts
A Phase 2 study testing NVN1000 8% Gel, NVN1000 16% and NVN1000 24% in people with Genital Warts and Perianal Warts, run by Novan, Inc. at 15 sites in United States.
Trial summary
A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects with External Genital Warts and Perianal Warts Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Genital Warts, Perianal Warts
- What is being tested?
- NVN1000 8% Gel, NVN1000 16% and NVN1000 24%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 15 sitesUnited States
- Study dates
- 12 Jun 2015to 17 Oct 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- At least 2 but not more than 20 genital/perianal warts with a maximum total wart surface area no more than 1% body surface area
- If a woman of child-bearing potential, have a negative pregnancy test and use effective contraception
- If currently receiving wart treatment, be willing to stop all treatment for 28 days prior to randomization and during the study
Who cannot join
- Immunocompromised patients including those with HIV, receiving radiation, or drugs that suppress the immune system
- Pregnant, planning to become pregnant, or nursing
- History of cancer (including cervical cancer) within 5 years, with exception of non-melanoma skin cancer in non-genital skin
- Recent history of other genital skin infections
- Active HSV and frequent HSV recurrences unless receiving suppression therapy
- Have hemoglobin < 10 G/dl or methemoglobin > 3%
- Known allergy to any component of the gel including excipients
- Previously participated in any study with NVN1000 or SB204
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
PPD 134
Atlanta, Georgia, 30005
PPD 139
Atlanta, Georgia, 30338
PPD 128
Corpus Christi, Texas, 78414
PPD 137
Fountain Valley, California, 92708
PPD 129
Houston, Texas, 77023
PPD 130
Indianapolis, Indiana, 46202
PPD 140
Lomita, California, 90717
PPD 126
Metairie, Louisiana, 70006
PPD 135
Philadelphia, Pennsylvania, 19107
PPD 132
Portland, Oregon, 97210
PPD 138
Roswell, Georgia, 30075
PPD 127
San Antonio, Texas, 78229
PPD 133
San Diego, California, 92123
PPD 136
Seattle, Washington, 98105
PPD 131
Webster, Texas, 75598
About this study
Official title: A Phase 2, Multi-center, Double-blind, Randomized, Vehicle-controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects With External Genital Warts and Perianal Warts
A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects with External Genital Warts and Perianal Warts
Read the detailed description
This is a phase 2, multi-center, randomized, double-blind, vehicle-controlled, ascending dose study to assess safety, tolerability and efficacy of a topical nitric oxide releasing compound in subjects with external genital and perianal warts. Eligible subjects will be treated with a topical gel (active or vehicle) for up to 12 weeks.
- Conditions
- Genital Warts, Perianal Warts
- Being tested
- NVN1000 8% Gel, NVN1000 16%, Vehicle, NVN1000 24%
- Keywords
- genital warts, perianal warts
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVN1000 8% GelDrug
Also called SB206
once and twice daily
NVN1000 16%Drug
Also called SB206
once daily
VehicleDrug
Also called Placebo
placebo comparator
NVN1000 24%Drug
Also called SB206
once daily
| Study group | Role | What they receive |
|---|---|---|
| NVN1000 8% Gel twice daily | Experimental | NVN1000 8% Gel twice daily Receives: Drug: NVN1000 8% Gel |
| NVN1000 8% Gel once daily | Experimental | NVN1000 8% Gel once daily Receives: Drug: NVN1000 8% Gel |
| NVN1000 16% Once daily | Experimental | NVN1000 16% Gel once daily Receives: Drug: NVN1000 16% |
| Vehicle Gel | Placebo comparator | Vehicle Gel at frequency to match active Receives: Drug: Vehicle |
| NVN1000 24% once daily | Experimental | NVN1000 24% once daily Receives: Drug: NVN1000 24% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12
Clearance of baseline external genital and perianal warts at or before Week 12 as determined by physical examination by the investigator.
Measured: 12 weeks
Secondary outcomes (4)
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Comparison of scores for erythema, edema, erosions/ulcers, itch between active and vehicle treated subjects using a 4 point grading scale; on the tolerability scale, 0 = none and 3 = severe, indicating an increase in severity the higher the number assigned.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12
Safety as Determined by Changes in Laboratory Assessments
Safety population--Comparison of changes in methemoglobin levels between active and vehicle treated subjects. Methemoglobin levels were measured using a RAD-57 pulse co-oximeter. Values are expressed as a percentage of hemoglobin.
Measured: Baseline, Week 2 and Week 12
Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12
The percentage of subjects with complete clearance of baseline and warts that emerge during treatment period as determined by physical examination by the investigator
Measured: 12 weeks
Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12
Percentage of subjects with complete or partial clearance of baseline warts as determined by physical examination by the investigator
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study start12 Jun 2015
- Primary completionOct 2016
- Study completion17 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Genital WartsStudies 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Joyce Rico, MD, Study director, Novan, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462187
- Sponsor's protocol ID
- NI-WA201
- Status last verified
- Apr 2023
- First submitted
- 28 May 2015
- Last updated
- 6 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. 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, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects With External Genital Warts and Perianal Warts
- ClinicalTrials.gov ID
- NCT02462187
- Acronym / sponsor ID
- NI-WA201
- Conditions
- Genital Warts, Perianal Warts
- Keywords
- genital warts, perianal warts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 12 Jun 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- 17 Oct 2016 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Posted 5 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects with External Genital Warts and Perianal Warts
Detailed description
This is a phase 2, multi-center, randomized, double-blind, vehicle-controlled, ascending dose study to assess safety, tolerability and efficacy of a topical nitric oxide releasing compound in subjects with external genital and perianal warts. Eligible subjects will be treated with a topical gel (active or vehicle) for up to 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| NVN1000 8% Gel twice daily | Experimental | Drug: NVN1000 8% GelNVN1000 8% Gel twice daily |
| NVN1000 8% Gel once daily | Experimental | Drug: NVN1000 8% GelNVN1000 8% Gel once daily |
| NVN1000 16% Once daily | Experimental | Drug: NVN1000 16%NVN1000 16% Gel once daily |
| Vehicle Gel | Placebo comparator | Drug: VehicleVehicle Gel at frequency to match active |
| NVN1000 24% once daily | Experimental | Drug: NVN1000 24%NVN1000 24% once daily |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- At least 2 but not more than 20 genital/perianal warts with a maximum total wart surface area no more than 1% body surface area
- If a woman of child-bearing potential, have a negative pregnancy test and use effective contraception
- If currently receiving wart treatment, be willing to stop all treatment for 28 days prior to randomization and during the study
Key exclusion criteria (8 listed)
- Immunocompromised patients including those with HIV, receiving radiation, or drugs that suppress the immune system
- Pregnant, planning to become pregnant, or nursing
- History of cancer (including cervical cancer) within 5 years, with exception of non-melanoma skin cancer in non-genital skin
- Recent history of other genital skin infections
- Active HSV and frequent HSV recurrences unless receiving suppression therapy
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 |
|---|---|---|
| NVN1000 8% GelAlso: SB206once and twice daily | Drug | NVN1000 8% Gel once daily, NVN1000 8% Gel twice daily |
| NVN1000 16%Also: SB206once daily | Drug | NVN1000 16% Once daily |
| VehicleAlso: Placeboplacebo comparator | Drug | Vehicle Gel |
| NVN1000 24%Also: SB206once daily | Drug | NVN1000 24% once daily |
Primary outcome
Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12
Time frame: 12 weeks
Clearance of baseline external genital and perianal warts at or before Week 12 as determined by physical examination by the investigator.
4 secondary outcomes
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12
Safety as Determined by Changes in Laboratory Assessments
Time frame: Baseline, Week 2 and Week 12
Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12
Time frame: 12 weeks
Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Genital Warts
Not yet recruiting
Efficacy and Safety of Oral Ivermectin for Genital Warts
Genital Warts
RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital Warts
Not yet recruitingPhase 3
Intralesional Acyclovir Versus Intralesional Zinc Sulphate in the Treatment of Plantar Warts
Warts, Plantar Warts
RecruitingObservational study
Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Psoriasis, Condyloma Acuminata
Not yet recruitingEarly Phase 1
the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.
Warts
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.
Joyce Rico, MD study director
Novan, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NVN1000 8% Gel, NVN1000 16% and NVN1000 24% in people with Genital Warts and Perianal Warts, run by Novan, Inc. at 15 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 3 inclusion and 8 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 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 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?
Yes. Results are posted in the registry (first posted 5 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12 (time frame: 12 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 6 Apr 2023.