Clinical trial NCT03436615: A Study to Evaluate the Safety and Efficacy of SB206 in Subjects With Molluscum Contagiosum
Official title: A Phase 2 Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Ascending Dose Study of SB206 in Subjects With Molluscum Contagiosum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Molluscum Contagiosum
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
First posted: 2018-02-19
Enrollment: 256
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase 2 multi-center, randomized, double-blind, vehicle-controlled ascending dose study to be conducted in non-immunocompromised subjects with molluscum contagiosum.

Detailed description: This is a phase 2 multi-center, randomized, double-blind, vehicle-controlled ascending dose study to be conducted in up to approximately 192 or 256 non-immunocompromised subjects with molluscum contagiosum. Subjects who satisfy entry criteria will be randomized 3:1 to ascending, sequential dose cohorts of SB206. The highest tolerated dose will also be run in a cohort once daily. Approximately 64 subjects will be randomized to each cohort. Subjects will be treated once daily, twice daily or three times a week for up to 12 weeks. After 30 subjects randomized in a cohort have completed 2 weeks of treatment, the Data Safety Monitoring Board (DSMB) will review the available unblinded safety and tolerability data. The DSMB will determine if the data supports escalating to the next highest dose for the next cohort or if the data shows the dose is not tolerable decreasing to the next lower dose or frequency for the next cohort.

Eligibility criteria: Inclusion Criteria:

* Be 2 years of age or older, and in good general health;
* Have signed written informed consent form by a parent or legal guardian (assent form where required);
* Have between 3 and 70 MC at baseline, excluding periocular (within 2 cm circumference of the eye) and lesions on the labia and penis;
* Females 10 years of age and older must have a negative urine pregnancy test prior to randomization;
* Females 10 years of age and older must agree to use an effective method of birth control during the course of the study and for 30 days after their final study visit;
* Be willing and able to follow study instructions and likely to complete all study requirements.

Exclusion Criteria:

* Are immunosuppressed, have immunodeficiency disorder, or are on immunosuppressive treatment;
* Have agminated MC that could make it difficult to provide accurate lesion counts;
* Have active atopic dermatitis with intense erythema and/or excoriations, that impact currently or could impact at any point during the study the ability to count MC lesions;
* Have significant eczematous reactions or other skin disease surrounding MC that may impact the ability to count lesions;
* Have received treatment with topical calcineurin inhibitors or steroids on MC or within 2 cm of MC lesions within 14 days prior to baseline;
* Have received treatment for MC during the 14 days prior to baseline with podophyllotoxin, imiquimod, cantharidin, sinecatechins, topical retinoids, oral or topical zinc, or other homeopathic or OTC products including, but not limited to, Zymaderm and tea tree oil, cimetidine and other histamine H2 receptor antagonists;
* Have received surgical procedures (cryotherapy, curettage, other) within 28 days prior to baseline;
* Have MC only in periocular area;
* Have MC only on the labia or penis;
* Female subjects who are pregnant, planning a pregnancy or breastfeeding;
* Have confirmed methemoglobin level of \>3.0% at Baseline using a pulse co-oximeter;
* Have know hypersensitivity to any ingredients of SB206 or Vehicle Gel including excipients;
* Have participated in a previous study with NVN1000;
* Have participated in any other trial of an interventional investigational drug or device within 30 days or concurrent participation in another interventional research study.

Primary outcomes:
measure: Proportion of Subjects Achieving Complete Clearance at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of Subjects Achieving Complete Clearance at Each Visit
timeFrame: Week 1; Week 2; Week 4; Week 8; Week 12
measure: Time to First Complete Clearance
timeFrame: Week 12
measure: Proportion of Subjects Achieving 75% Reduction at Each Visit
timeFrame: Week 1, Week 2, Week 4, Week 8, Week 12
measure: Mean Change in Molluscum Contagiosum at Each Visit
timeFrame: Week 1, Week 2, Week 4, Week 8, Week 12
measure: Percent Change in Molluscum Contagiosum at Each Visit
timeFrame: Week 1, Week 2, Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Premier Site# 266
state: Arizona
city: Santa Ana
country: United States
facility: Premier Site# 260
state: California
city: Thornton
country: United States
facility: Premier Site# 257
state: Colorado
city: Doral
country: United States
facility: Premier Site# 264
state: Florida
city: Newnan
country: United States
facility: Premier Site# 116
state: Georgia
city: Indianapolis
country: United States
facility: Premier Site# 251
state: Indiana
city: Lenexa
country: United States
facility: Premier Site# 253
state: Kansas
city: Louisville
country: United States
facility: Premier Site# 117
state: Kentucky
city: Las Vegas
country: United States
facility: Premier Site# 182
state: Nevada
city: Norman
country: United States
facility: Premier Site# 252
state: Oklahoma
city: Gresham
country: United States
facility: Premier Site# 237
state: Oregon
city: Charleston
country: United States
facility: Premier Site# 259
state: South Carolina
city: Mount Pleasant
country: United States
facility: Premier Site# 255
state: South Carolina
city: Houston
country: United States
facility: Premier Site# 131
state: Texas
city: Houston
country: United States
facility: Premier Site# 167
state: Texas
city: San Antonio
country: United States
facility: Premier Site# 224
state: Texas
city: Salt Lake City
country: United States
facility: Premier Site# 256
state: Utah
city: Richmond
country: United States
facility: Premier Site# 267
state: Virginia
Study officials:
affiliation: Novan, Inc.
name: Tomoko Maeda-Chubachi, MD
role: STUDY_CHAIR
References: