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| Name | Class |
|---|---|
| Therapeutics, Inc. | INDUSTRY |
| Synteract, Inc. | INDUSTRY |
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This is a phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in up to approximately 850 subjects 6 months of age and older with molluscum contagiosum (MC). Subjects or their caregivers will apply SB206 10.3% or Vehicle Gel once daily for a minimum of 4 weeks and up to 12 weeks to all lesions identified at Baseline and new treatable lesions that arise during the course of the study.
This is a phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in up to approximately 850 subjects 6 months of age and older with molluscum contagiosum (MC). After obtaining informed consent/assent, subjects who satisfy entry criteria will be randomized 1:1 (active:vehicle). Subjects receiving current treatment for MC at the time of the Screening Visit will enter a wash out period of up to 14 days prior to randomization.
Subjects or their caregivers will apply treatment once daily to all lesions identified at Baseline and new lesions that arise during treatment for a minimum of 4 weeks and up to 12 weeks. If the investigator determines all lesions are cleared at a visit, the treatment may stop. If treatment is stopped due to clearance, subjects will continue regularly scheduled visits through Week 24/ET2. Study drug will be dispensed through Week 12/ET1 in case of lesion recurrence between study visits. At each visit subsequent to stopping treatment due to clearance, the investigator will determine if new lesions have occurred since the last visit, and if so, the subject or caregiver will be instructed by the investigator to re-initiate treatment. If the subject or caregiver see new lesions or re-occurrence of lesions in between visits, they should treat these lesions until the next visit. No study drug will be provided after the Week 12 visit. The subject or caregiver will apply study drug to the individual lesions. Periocular lesions will be treated if the lesions are at least 2 cm from the edge of the eye. Subjects will visit the clinic in person at Screening/Baseline, Week 2, Week 4 (unless visit is performed remotely), Week 8, Week 12, and Week 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB206 10.3% berdazimer | Experimental | SB206 10.3% berdazimer topically once daily |
|
| vehicle gel | Placebo Comparator | Vehicle gel topically once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB206 10.3% berdazimer | Drug | Topically once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Clearance of All Treatable MC at Week 12 | Percent (proportion) of subjects with complete clearance of all treatable MC at Week 12. This was measured by dividing the number of subjects who showed complete clearance by the number in that treatment group (this represents our primary outcome variable). | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| A Lesion Count of 0 or 1 of All Treatable MC at Week 12 | Percent (proportion) of subjects achieving a lesion count of 0 or 1 of all treatable MC at Week 12. | 12 Weeks |
| 90% Reduction From Baseline in the Number of All Treatable MC at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomoko Maeda Chubachi, MD PhD | Novan, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #312 | Glendale | Arizona | 85308 | United States | ||
| Site #101 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36287306 | Derived | Browning JC, Cartwright M, Thorla I Jr, Martin SA, Olayinka-Amao O, Maeda-Chubachi T. A Patient-Centered Perspective of Molluscum Contagiosum as Reported by B-SIMPLE4 Clinical Trial Patients and Caregivers: Global Impression of Change and Exit Interview Substudy Results. Am J Clin Dermatol. 2023 Jan;24(1):119-133. doi: 10.1007/s40257-022-00733-9. Epub 2022 Oct 26. | |
| 35830173 |
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Subjects receiving current treatment for MC at the time of the Screening Visit entered a wash out period of up to 14 days prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | SB206 10.3% Berdazimer | SB206 10.3% berdazimer topically once daily SB206 10.3% berdazimer: Topically once daily |
| FG001 | Vehicle Gel | Vehicle gel topically once daily vehicle gel: Topically once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2020 | Nov 11, 2022 |
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| vehicle gel | Drug | Topically once daily |
|
Percent (proportion) of subjects achieving at least a 90% reduction from Baseline in the number of all treatable MC at Week 12
| 12 Weeks |
| Complete Clearance of All Treatable MC at Week 8 | Percent (proportion) of subjects with complete clearance of all treatable MC at Week 8. This was measured by dividing the number of subjects who showed complete clearance at week 8 by the number in that treatment group (this represents our secondary outcome variable). | 8 Weeks |
| Change From Baseline in the Number of All Treatable MC at Week 4 | Percent change from Baseline in the number of all treatable MC at Week 4 | 4 Weeks |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Site #272 | Rogers | Arkansas | 72758 | United States |
| Site #336 | Fountain Valley | California | 92708 | United States |
| Site #329 | Fremont | California | 94538 | United States |
| Site# 348 | Fresno | California | 93711 | United States |
| Site #161 | San Diego | California | 92103 | United States |
| Site #327 | Thousand Oaks | California | 91320 | United States |
| Site #325 | Greenwood Village | Colorado | 80111 | United States |
| Site #335 | Apopka | Florida | 32703 | United States |
| Site #342 | Boca Raton | Florida | 33428 | United States |
| Site #333 | Fort Lauderdale | Florida | 33316 | United States |
| Site #334 | Homestead | Florida | 33030 | United States |
| Site #278 | Miami | Florida | 33165 | United States |
| Site #314 | Miami Lakes | Florida | 33014 | United States |
| Site #341 | Orlando | Florida | 32829 | United States |
| Site #227 | Sanford | Florida | 32771 | United States |
| Site #305 | Tampa | Florida | 33163 | United States |
| Site #116 | Newnan | Georgia | 30263 | United States |
| Site #340 | Chicago | Illinois | 60611 | United States |
| Site #253 | Rolling Meadows | Illinois | 60008 | United States |
| Site #288 | Evansville | Indiana | 47715 | United States |
| Site #310 | Plainfield | Indiana | 46168 | United States |
| Site #328 | Bowling Green | Kentucky | 42101 | United States |
| Site #347 | Lexington | Kentucky | 40517 | United States |
| Site # 117 | Louisville | Kentucky | 40241 | United States |
| Site #294 | Owensboro | Kentucky | 42301 | United States |
| Site #321 | Baton Rouge | Louisiana | 70809 | United States |
| Site# 349 | Covington | Louisiana | 70433 | United States |
| Site #332 | New Orleans | Louisiana | 70119 | United States |
| Site #297 | New Orleans | Louisiana | 70124 | United States |
| Site #330 | Rockville | Maryland | 20854 | United States |
| Site #346 | Brighton | Massachusetts | 02135 | United States |
| Site #274 | Clarkston | Michigan | 48346 | United States |
| Site #121 | New Brighton | Minnesota | 55112 | United States |
| Site #338 | Omaha | Nebraska | 68114 | United States |
| Site #201 | Berlin | New Jersey | 08009 | United States |
| Site #331 | Verona | New Jersey | 07044 | United States |
| Site #279 | Greensboro | North Carolina | 27408 | United States |
| Site #250 | Portland | Oregon | 97210 | United States |
| Site #265 | Sugarloaf | Pennsylvania | 18249 | United States |
| Site #311 | Warwick | Rhode Island | 02866 | United States |
| Site #295 | Fountain Inn | South Carolina | 29644 | United States |
| Site #255 | Summerville | South Carolina | 29486 | United States |
| Site #291 | Kingsport | Tennessee | 37660 | United States |
| Site #326 | Knoxville | Tennessee | 37909 | United States |
| Site #316 | Murfreesboro | Tennessee | 37130 | United States |
| Site #337 | Houston | Texas | 77087 | United States |
| Site #299 | Longview | Texas | 75605 | United States |
| Site #224 | San Antonio | Texas | 78218 | United States |
| Site #281 | Layton | Utah | 84041 | United States |
| Site #345 | West Jordan | Utah | 84088 | United States |
| Site #267 | Richmond | Virginia | 23294 | United States |
| Site #339 | Spokane | Washington | 99202 | United States |
| Site #343 | Morgantown | West Virginia | 26505 | United States |
| Browning JC, Enloe C, Cartwright M, Hebert A, Paller AS, Hebert D, Kowalewski EK, Maeda-Chubachi T. Efficacy and Safety of Topical Nitric Oxide-Releasing Berdazimer Gel in Patients With Molluscum Contagiosum: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2022 Aug 1;158(8):871-878. doi: 10.1001/jamadermatol.2022.2721. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SB206 10.3% Berdazimer | SB206 10.3% berdazimer topically once daily SB206 10.3% berdazimer: Topically once daily |
| BG001 | Vehicle Gel | Vehicle gel topically once daily vehicle gel: Topically once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||
| Baseline number of Molluscum lesions | Mean | Standard Deviation | Molluscum lesions |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Clearance of All Treatable MC at Week 12 | Percent (proportion) of subjects with complete clearance of all treatable MC at Week 12. This was measured by dividing the number of subjects who showed complete clearance by the number in that treatment group (this represents our primary outcome variable). | ITT | Posted | Count of Participants | Participants | 12 Weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | A Lesion Count of 0 or 1 of All Treatable MC at Week 12 | Percent (proportion) of subjects achieving a lesion count of 0 or 1 of all treatable MC at Week 12. | ITT | Posted | Count of Participants | Participants | 12 Weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | 90% Reduction From Baseline in the Number of All Treatable MC at Week 12 | Percent (proportion) of subjects achieving at least a 90% reduction from Baseline in the number of all treatable MC at Week 12 | ITT | Posted | Count of Participants | Participants | 12 Weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Complete Clearance of All Treatable MC at Week 8 | Percent (proportion) of subjects with complete clearance of all treatable MC at Week 8. This was measured by dividing the number of subjects who showed complete clearance at week 8 by the number in that treatment group (this represents our secondary outcome variable). | ITT | Posted | Count of Participants | Participants | 8 Weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Number of All Treatable MC at Week 4 | Percent change from Baseline in the number of all treatable MC at Week 4 | ITT | Posted | Least Squares Mean | Standard Error | percentage of change from baseline | 4 Weeks |
|
|
Baseline visit to end of study visit, 84 days.
Only TEAE were to be considered.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SB206 | SB206 gel applied topically, once daily for 12 weeks. | 0 | 444 | 0 | 444 | 221 | 444 |
| EG001 | Placebo | Placebo gel applied topically, once daily for 12 weeks. | 0 | 447 | 1 | 447 | 37 | 447 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supracondylar Fracture of right humerus, closed reduction | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment | Moderate/unrelated/hospitalization |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Application site exfoliation | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Application site dermatitis | General disorders | MedDRA 23.0 | Systematic Assessment |
|
The PI must wait 18 months after the closeout of the trial at all Study sites or until the publication of the multi-site Sponsor results. The only restriction on PI publication after that time is that the sponsor can review results communications prior to public release and can request confidential or proprietary information be removed or can embargo communications regarding trial results for a period that is more than 90 days but less than 120 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cathy White, Vice President, Drug Development Operations | Novan | 919-485-8080 | clinical@novan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2021 | Nov 11, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008976 | Molluscum Contagiosum |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000709171 | berdazimer sodium |
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| Title | Measurements |
|---|---|
|
| 2 years old to <6 years old |
|
| 6 years old to <12 years old |
|
| 12 years old to <18 years old |
|
| 18 years old |
|
| Male |
|
| Not Hispanic or Latino |
|
| Ethnicity Not Reported |
|
| Unknown |
|
| American Indian or Alaska Native |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| More than One Race |
|
| Race Not Reported |
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