A Phase 2 interventional study of NVN1000 8% Gel and NVN1000 16% in Genital Warts and Perianal Warts, sponsored by Novan, Inc.. Completed at 15 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by Novan, Inc. · Phase 2, Interventional, and Treatment
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
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.
116 studies on the registry are indexed under Condylomata Acuminata; 11 are open to participants now.
This study's enrollment of 108 is below the median of 158 across 95 interventional studies indexed under Condylomata Acuminata.
Browse Condylomata Acuminata studies →Novan, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NVN1000 8% Gel twice daily
Drug: NVN1000 8% Gel
NVN1000 8% Gel once daily
Drug: NVN1000 8% Gel
NVN1000 16% Gel once daily
Drug: NVN1000 16%
Vehicle Gel at frequency to match active
Drug: Vehicle
NVN1000 24% once daily
Drug: NVN1000 24%
once and twice daily
Also known as: SB206
once daily
Also known as: SB206
placebo comparator
Also known as: Placebo
once daily
Also known as: SB206
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.
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 12 weeks
120 subjects were planned to be enrolled; 108 subjects were actually enrolled per the Sponsor's decision.
| Milestone | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily |
|---|---|---|---|---|---|---|
| Started | 13 | 24 | 14 | 30 | 23 | 4 |
| Completed | 8 | 19 | 9 | 23 | 16 | 4 |
| Not completed | 5 | 5 | 5 | 7 | 7 | 0 |
Clearance of baseline external genital and perianal warts at or before Week 12 as determined by physical examination by the investigator.
| Participants | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily |
|---|---|---|---|---|---|---|
| Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12 | 2 | 5 | 2 | 10 | 1 | 2 |
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.
| Participants | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily |
|---|---|---|---|---|---|---|
| Erythema: Baseline — 0 (none) | 12 | 23 | 14 | 27 | 20 | 4 |
| Erythema: Baseline — 1 (mild) | 0 | 0 | 0 | 2 | 0 | 0 |
| Erythema: Baseline — 2 (moderate) | 0 | 0 | 0 | 0 | 0 | 0 |
| Erythema: Baseline — 3 (severe) | 0 | 0 | 0 | 0 | 0 | 0 |
| Erythema: Baseline — Missing/unknown | 0 | 0 | 0 | 1 | 0 | 0 |
| Erythema: Week 2 — 0 (none) | 6 | 16 | 11 | 19 | 18 | 4 |
| Erythema: Week 2 — 1 (mild) | 2 | 4 | 1 | 9 | 1 | 0 |
| Erythema: Week 2 — 2 (moderate) | 3 | 2 | 2 | 2 | 0 | 0 |
| Erythema: Week 2 — 3 (severe) | 1 | 0 | 0 | 0 | 0 | 0 |
| Erythema: Week 2 — Missing/unknown | 0 | 1 | 0 | 0 | 1 | 0 |
| Erythema: Week 4 — 0 (none) | 6 | 14 | 9 | 20 | 19 | 4 |
| Erythema: Week 4 — 1 (mild) | 3 | 4 | 3 | 6 | 0 | 0 |
| Erythema: Week 4 — 2 (moderate) | 0 | 3 | 1 | 2 | 0 | 0 |
| Erythema: Week 4 — 3 (severe) | 0 | 0 | 0 | 0 | 0 | 0 |
| Erythema: Week 4 — Missing/unknown | 3 | 2 | 1 | 2 | 1 | 0 |
| Erythema: Week 8 — 0 (none) | 8 | 13 | 8 | 18 | 16 | 4 |
| Erythema: Week 8 — 1 (mild) | 0 | 3 | 2 | 3 | 1 | 0 |
| Erythema: Week 8 — 2 (moderate) | 1 | 2 | 1 | 4 | 0 | 0 |
| Erythema: Week 8 — 3 (severe) | 0 | 0 | 0 | 1 | 0 | 0 |
| Erythema: Week 8 — Missing/unknown | 3 | 5 | 3 | 4 | 3 | 0 |
| Erythema: Week 12 — 0 (none) | 8 | 15 | 6 | 19 | 18 | 4 |
| Erythema: Week 12 — 1 (mild) | 0 | 2 | 2 | 3 | 2 | 0 |
| Erythema: Week 12 — 2 (moderate) | 0 | 2 | 1 | 0 | 0 | 0 |
| Erythema: Week 12 — 3 (severe) | 0 | 0 | 0 | 1 | 0 | 0 |
| Erythema: Week 12 — Missing/unknown | 4 | 4 | 5 | 7 | 0 | 0 |
| Edema: Baseline — 0 (none) | 12 | 23 | 14 | 28 | 20 | 4 |
| Edema: Baseline — 1 (mild) | 0 | 0 | 0 | 1 | 0 | 0 |
| Edema: Baseline — 2 (moderate) | 0 | 0 | 0 | 0 | 0 | 0 |
| Edema: Baseline — 3 (severe) | 0 | 0 | 0 | 0 | 0 | 0 |
| Edema: Baseline — Missing/unknown | 0 | 0 | 0 | 1 | 0 | 0 |
| Edema: Week 2 — 0 (none) | 10 | 22 | 12 | 26 | 19 | 4 |
| Edema: Week 2 — 1 (mild) | 0 | 0 | 1 | 4 | 0 | 0 |
| Edema: Week 2 — 2 (moderate) | 2 | 0 | 1 | 0 | 0 | 0 |
| Edema: Week 2 — 3 (severe) | 0 | 0 | 0 | 0 | 0 | 0 |
| Edema: Week 2 — Missing/unknown | 0 | 1 | 0 | 0 | 1 | 0 |
| Edema: Week 4 — 0 (none) | 9 | 19 | 11 | 25 | 19 | 4 |
| Edema: Week 4 — 1 (mild) | 1 | 2 | 2 | 3 | 0 | 0 |
| Edema: Week 4 — 2 (moderate) | 0 | 0 | 0 | 0 | 0 | 0 |
| Edema: Week 4 — 3 (severe) | 0 | 0 | 0 | 0 | 0 | 0 |
| Edema: Week 4 — Missing/unknown | 2 | 2 | 1 | 2 | 1 | 0 |
| Edema: Week 8 — 0 (none) | 8 | 18 | 10 | 24 | 17 | 4 |
| Edema: Week 8 — 1 (mild) | 1 | 0 | 0 | 1 | 0 | 0 |
| Edema: Week 8 — 2 (moderate) | 0 | 0 | 1 | 1 | 0 | 0 |
| Edema: Week 8 — 3 (severe) | 0 | 0 | 0 | 0 | 0 | 0 |
| Edema: Week 8 — Missing/unknown | 3 | 5 | 3 | 4 | 3 | 0 |
| Edema: Week 12 — 0 (none) | 8 | 18 | 8 | 20 | 16 | 4 |
| Edema: Week 12 — 1 (mild) | 0 | 1 | 1 | 2 | 0 | 0 |
| Edema: Week 12 — 2 (moderate) | 0 | 0 | 0 | 1 | 0 | 0 |
| Edema: Week 12 — 3 (severe) | 0 | 0 | 0 | 0 | 0 | 0 |
| Edema: Week 12 — Missing/unknown | 4 | 4 | 5 | 7 | 4 | 0 |
| Erosion/Ulceration: Baseline — 0 (none) | 12 | 23 | 14 | 28 | 20 | 4 |
| Erosion/Ulceration: Baseline — 1 (mild) | 0 | 0 | 0 | 1 | 0 | 0 |
| Erosion/Ulceration: Baseline — 2 (moderate) | 0 | 0 | 0 | 0 | 0 | 0 |
| Erosion/Ulceration: Baseline — 3 (severe) | 0 | 0 | 0 | 0 | 0 | 0 |
| Erosion/Ulceration: Baseline — Missing/unknown | 0 | 0 | 0 | 1 | 0 | 0 |
| Erosion/Ulceration: Week 2 — 0 (none) | 8 | 18 | 14 | 27 | 19 | 4 |
| Erosion/Ulceration: Week 2 — 1 (mild) | 3 | 4 | 0 | 2 | 0 | 0 |
| Erosion/Ulceration: Week 2 — 2 (moderate) | 0 | 0 | 0 | 0 | 0 | 0 |
| Erosion/Ulceration: Week 2 — 3 (severe) | 1 | 0 | 0 | 1 | 0 | 0 |
| Erosion/Ulceration: Week 2 — Missing/unknown | 0 | 1 | 0 | 0 | 1 | 0 |
| Erosion/Ulceration: Week 4 — 0 (none) | 9 | 18 | 13 | 24 | 19 | 4 |
| Erosion/Ulceration: Week 4 — 1 (mild) | 0 | 2 | 0 | 3 | 0 | 0 |
| Erosion/Ulceration: Week 4 — 2 (moderate) | 1 | 0 | 0 | 1 | 0 | 0 |
| Erosion/Ulceration: Week 4 — 3 (severe) | 0 | 1 | 0 | 0 | 0 | 0 |
| Erosion/Ulceration: Week 4 — Missing/unknown | 2 | 2 | 1 | 2 | 1 | 0 |
| Erosion/ulceration: Week 8 — 0 (none) | 8 | 15 | 11 | 20 | 20 | 4 |
| Erosion/ulceration: Week 8 — 1 (mild) | 0 | 2 | 0 | 4 | 0 | 0 |
| Erosion/ulceration: Week 8 — 2 (moderate) | 1 | 1 | 0 | 2 | 0 | 0 |
| Erosion/ulceration: Week 8 — 3 (severe) | 0 | 0 | 0 | 0 | 0 | 0 |
| Erosion/ulceration: Week 8 — Missing/unknown | 3 | 5 | 3 | 4 | 0 | 0 |
| Erosion/ulceration: Week 12 — 0 (none) | 8 | 16 | 8 | 20 | 20 | 4 |
| Erosion/ulceration: Week 12 — 1 (mild) | 0 | 3 | 1 | 2 | 0 | 0 |
| Erosion/ulceration: Week 12 — 2 (moderate) | 0 | 0 | 0 | 1 | 0 | 0 |
| Erosion/ulceration: Week 12 — 3 (severe) | 0 | 0 | 0 | 0 | 0 | 0 |
| Erosion/ulceration: Week 12 — Missing/unknown | 4 | 4 | 5 | 7 | 0 | 0 |
| Burning/stinging: Baseline — 0 (none) | 12 | 23 | 14 | 28 | 20 | 4 |
| Burning/stinging: Baseline — 1 (mild) | 0 | 0 | 0 | 0 | 0 | 0 |
| Burning/stinging: Baseline — 2 (moderate) | 0 | 0 | 0 | 1 | 0 | 0 |
| Burning/stinging: Baseline — 3 (severe) | 0 | 0 | 0 | 0 | 0 | 0 |
| Burning/stinging: Baseline — Missing/unknown | 0 | 0 | 0 | 1 | 0 | 0 |
| Burning/stinging: Week 2 — 0 (none) | 6 | 16 | 8 | 17 | 15 | 2 |
| Burning/stinging: Week 2 — 1 (mild) | 3 | 5 | 4 | 10 | 4 | 2 |
| Burning/stinging: Week 2 — 2 (moderate) | 0 | 1 | 2 | 3 | 0 | 0 |
| Burning/stinging: Week 2 — 3 (severe) | 3 | 0 | 0 | 0 | 0 | 0 |
| Burning/stinging: Week 2 — Missing/unknown | 0 | 1 | 0 | 0 | 1 | 0 |
| Burning/stinging: Week 4 — 0 (none) | 6 | 15 | 6 | 18 | 16 | 3 |
| Burning/stinging: Week 4 — 1 (mild) | 2 | 3 | 7 | 5 | 3 | 1 |
| Burning/stinging: Week 4 — 2 (moderate) | 2 | 3 | 0 | 2 | 0 | 0 |
| Burning/stinging: Week 4 — 3 (severe) | 0 | 0 | 0 | 3 | 0 | 0 |
| Burning/stinging: Week 4 — Missing/unknown | 2 | 2 | 1 | 2 | 1 | 0 |
| Burning/stinging: Week 8 — 0 (none) | 6 | 13 | 8 | 19 | 13 | 2 |
| Burning/stinging: Week 8 — 1 (mild) | 1 | 3 | 2 | 6 | 3 | 2 |
| Burning/stinging: Week 8 — 2 (moderate) | 2 | 2 | 1 | 1 | 1 | 0 |
| Burning/stinging: Week 8 — 3 (severe) | 0 | 0 | 0 | 0 | 0 | 0 |
| Burning/stinging: Week 8 — Missing/unknown | 3 | 5 | 3 | 4 | 3 | 0 |
| Burning/stinging: Week 12 — 0 (none) | 6 | 13 | 8 | 19 | 14 | 4 |
| Burning/stinging: Week 12 — 1 (mild) | 1 | 3 | 1 | 2 | 1 | 0 |
| Burning/stinging: Week 12 — 2 (moderate) | 1 | 3 | 0 | 1 | 1 | 0 |
| Burning/stinging: Week 12 — 3 (severe) | 0 | 0 | 0 | 1 | 0 | 0 |
| Burning/stinging: Week 12 — Missing/unknown | 4 | 4 | 5 | 7 | 4 | 0 |
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.
| Percentage | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily |
|---|---|---|---|---|---|---|
| Baseline | 1.33 (0.7 to 1.7) | 1.25 (0.7 to 2.1) | 1.38 (0.8 to 2.1) | 1.29 (0.6 to 2.1) | 1.31 (0.5 to 2.0) | 1.53 (1.2 to 1.7) |
| Week 2 | 1.33 (0.7 to 2.0) | 1.33 (0.9 to 2.7) | 1.42 (0.9 to 1.9) | 1.33 (0.8 to 2.1) | 1.34 (0.9 to 1.9) | 1.48 (1.2 to 1.7) |
| Week 12 | 1.55 (1.0 to 2.5) | 1.34 (0.8 to 2.8) | 1.26 (0.8 to 1.8) | 1.36 (0.9 to 2.1) | 1.59 (0.7 to 4.0) | 1.50 (1.1 to 2.7) |
The percentage of subjects with complete clearance of baseline and warts that emerge during treatment period as determined by physical examination by the investigator
| Participants | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily |
|---|---|---|---|---|---|---|
| Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12 | 2 | 5 | 2 | 9 | 1 | 2 |
Percentage of subjects with complete or partial clearance of baseline warts as determined by physical examination by the investigator
| Participants | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily |
|---|---|---|---|---|---|---|
| Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12 | 8 | 19 | 10 | 17 | 11 | 2 |
Collected over Adverse events were collected from the time the subject signed the informed consent and completed any study assessment until the end of the final study visit, up to approximately 12 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: NVN1000 8% Gel Twice Daily | 0/12 (0%) | 2/12 (16.7%) | 9/12 (75%) |
| Cohort 2: NVN1000 8% Gel Once Daily | 0/23 (0%) | 0/23 (0%) | 13/23 (56.5%) |
| Cohort 3: NVN1000 16% Once Daily | 0/14 (0%) | 1/14 (7.1%) | 5/14 (35.7%) |
| Cohort 4: NVN1000 24% Once Daily | 0/30 (0%) | 0/30 (0%) | 7/30 (23.3%) |
| Vehicle Gel Once Daily | 0/20 (0%) | 0/20 (0%) | 4/20 (20%) |
| Vehicle Gel Twice Daily | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Event | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily |
|---|---|---|---|---|---|---|
| Abdominal adhesionsGastrointestinal disorders | 1/12 | 0/23 | 0/14 | 0/30 | 0/20 | 0/4 |
| CellulitisInfections and infestations | 1/12 | 0/23 | 0/14 | 0/30 | 0/20 | 0/4 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/12 | 0/23 | 0/14 | 0/30 | 0/20 | 0/4 |
| Affective disorderPsychiatric disorders | 0/12 | 0/23 | 1/14 | 0/30 | 0/20 | 0/4 |
| Event | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily |
|---|---|---|---|---|---|---|
| Application Site PainGeneral disorders | 3/12 | 1/23 | 0/14 | 2/30 | 0/20 | 0/4 |
| Application Site PruritusGeneral disorders | 1/12 | 5/23 | 0/14 | 0/30 | 0/20 | 0/4 |
| Application Site ReactionGeneral disorders | 2/12 | 1/23 | 0/14 | 0/30 | 1/20 | 0/4 |
| Application Site ExfoliationGeneral disorders | 0/12 | 3/23 | 0/14 | 0/30 | 0/20 | 0/4 |
| DiarrhoeaGastrointestinal disorders | 0/12 | 2/23 | 1/14 | 0/30 | 0/20 | 0/4 |
| Food PoisoningGastrointestinal disorders | 0/12 | 2/23 | 1/14 | 0/30 | 0/20 | 0/4 |
| Application Site BurnGeneral disorders | 1/12 | 0/23 | 0/14 | 0/30 | 0/20 | 0/4 |
| Application Site ErosionGeneral disorders | 1/12 | 0/23 | 0/14 | 2/30 | 0/20 | 0/4 |
| Application Site ErythemaGeneral disorders | 1/12 | 0/23 | 0/14 | 2/30 | 0/20 | 0/4 |
| Application Site RashGeneral disorders | 1/12 | 1/23 | 0/14 | 0/30 | 0/20 | 0/4 |
Intent to Treat Population (ITT)--the ITT includes all study subjects who were randomized and dispensed study medication.
| Age, Continuous(years) | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily | Total |
|---|---|---|---|---|---|---|---|
| Mean | 36.8 ± 7.13 | 33.3 ± 6.68 | 32.5 ± 7.86 | 33.6 ± 6.77 | 32.2 ± 7.41 | 31.5 ± 9.00 | 33.4 ± 7.12 |
| Sex: Female, Male(Participants) | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily | Total |
|---|---|---|---|---|---|---|---|
| Female | 6 | 8 | 2 | 7 | 6 | 2 | 31 |
| Male | 6 | 16 | 12 | 23 | 17 | 2 | 76 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 6 | 5 | 5 | 9 | 2 | 30 |
| Not Hispanic or Latino | 9 | 18 | 9 | 25 | 14 | 2 | 77 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 8 | 3 | 10 | 5 | 0 | 29 |
| White | 9 | 16 | 11 | 19 | 17 | 4 | 76 |
| More than one race | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily | Total |
|---|---|---|---|---|---|---|---|
| United States | 12 | 24 | 14 | 30 | 23 | 4 | 107 |
| Current Tobacco Use(Participants) | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily | Total |
|---|---|---|---|---|---|---|---|
| Yes | 5 | 5 | 2 | 12 | 8 | 3 | 35 |
| No | 7 | 19 | 12 | 18 | 15 | 1 | 72 |
| Wart Location at Baseline(Participants) | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily | Total |
|---|---|---|---|---|---|---|---|
| External genital warts (EGW) only | 9 | 17 | 13 | 19 | 15 | 3 | 76 |
| Perianal warts (PAW) only | 2 | 2 | 0 | 7 | 1 | 1 | 13 |
| EGW and PAW | 1 | 5 | 1 | 4 | 7 | 0 | 18 |
| Baseline Wart Count(number of warts) | Cohort 1: NVN1000 8% Gel Twice Daily | Cohort 2: NVN1000 8% Gel Once Daily | Cohort 3: NVN1000 16% Once Daily | Cohort 4: NVN1000 24% Once Daily | Vehicle Gel Once Daily | Vehicle Gel Twice Daily | Total |
|---|---|---|---|---|---|---|---|
| Mean | 9.3 ± 5.93 | 7.5 ± 5.05 | 5.1 ± 2.60 | 7.2 ± 5.58 | 7.7 ± 5.83 | 7.8 ± 3.40 | 7.4 ± 5.19 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2015 to primary completion in Oct 2016, 16 months.
Results were first posted in Apr 2023, 6 years 6 months after primary completion. A results delay was requested in Dec 2017.
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Studies of the drug tested here: Berdazimer sodium