A Phase 3 Molluscum Contagiosum Efficacy and Safety Study (B-SIMPLE4)

• ClinicalTrials.gov Identifier: NCT04535531
• Recruitment Status: Completed
• First Posted: September 2, 2020
• Results First Posted: January 26, 2023
• Last Update Posted: January 26, 2023
• Sponsor: Novan, Inc.
• Collaborators: Therapeutics, Inc.; Synteract, Inc.
• Information provided by (Responsible Party): Novan, Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Molluscum Contagiosum
• Interventions: Drug: SB206 10.3% berdazimer; Drug: vehicle gel
• Enrollment: 891

Participant Flow

Recruitment Details
Pre-assignment Details	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.

Arm/Group Title	SB206 10.3% Berdazimer	Vehicle Gel
Arm/Group Description	SB206 10.3% berdazimer topically once daily SB206 10.3% berdazimer: Topically once daily	Vehicle gel topically once daily vehicle gel: Topically once daily
Period Title: Overall Study
Started	444	447
Completed	363	390
Not Completed	81	57

Baseline Characteristics

Arm/Group Title		SB206 10.3% Berdazimer	Vehicle Gel	Total
Arm/Group Description		SB206 10.3% berdazimer topically once daily SB206 10.3% berdazimer: Topically once daily	Vehicle gel topically once daily vehicle gel: Topically once daily	Total of all reporting groups
Overall Number of Baseline Participants		444	447	891
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	444 participants	447 participants	891 participants
<1 year old		1	0	891
1 to <2 years old		15	12	27
2 years old to <6 years old		220	213	433
6 years old to <12 years old		178	201	379
12 years old to <18 years old		24	15	39
18 years old		6	6	12
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	444 participants	447 participants	891 participants
	Female	216 48.6%	234 52.3%	450 50.5%
	Male	228 51.4%	213 47.7%	441 49.5%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	444 participants	447 participants	891 participants
Hispanic or Latino		94 21.2%	87 19.5%	181 20.3%
Not Hispanic or Latino		345 77.7%	357 79.9%	702 78.8%
Ethnicity Not Reported		4 0.9%	1 0.2%	5 0.6%
Unknown		1 0.2%	2 0.4%	3 0.3%
American Indian or Alaska Native		2 0.5%	2 0.4%	4 0.4%
Asian		6 1.4%	6 1.3%	12 1.3%
Black or African American		21 4.7%	28 6.3%	49 5.5%
Native Hawaiian or Other Pacific Islander		4 0.9%	2 0.4%	6 0.7%
White		387 87.2%	382 85.5%	769 86.3%
More than One Race		13 2.9%	13 2.9%	26 2.9%
Race Not Reported		11 2.5%	14 3.1%	25 2.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	444 participants	447 participants	891 participants
		444	447	891
Baseline number of Molluscum lesions; Mean (Standard Deviation); Unit of measure: Molluscum lesions
	Number Analyzed	444 participants	447 participants	891 participants
		23.1 (17.60)	20.5 (16.18)	21.8 (16.94)

Outcome Measures

1. Primary Outcome

Title	Complete Clearance of All Treatable MC at Week 12
Description	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).
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SB206	Placebo
Arm/Group Description:	SB206 gel applied topically, once daily for 12 weeks.	Placebo gel applied topically, once daily for 12 weeks.
Overall Number of Participants Analyzed	444	447
Measure Type: Count of Participants; Unit of Measure: Participants
	144 32.4%	88 19.7%

2. Secondary Outcome

Title	A Lesion Count of 0 or 1 of All Treatable MC at Week 12
Description	Percent (proportion) of subjects achieving a lesion count of 0 or 1 of all treatable MC at Week 12.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SB206	Placebo
Arm/Group Description:	SB206 gel applied topically, once daily for 12 weeks.	Placebo gel applied topically, once daily for 12 weeks.
Overall Number of Participants Analyzed	444	447
Measure Type: Count of Participants; Unit of Measure: Participants
	193 43.5%	110 24.6%

3. Secondary Outcome

Title	90% Reduction From Baseline in the Number of All Treatable MC at Week 12
Description	Percent (proportion) of subjects achieving at least a 90% reduction from Baseline in the number of all treatable MC at Week 12
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SB206	Placebo
Arm/Group Description:	SB206 gel applied topically, once daily for 12 weeks.	Placebo gel applied topically, once daily for 12 weeks.
Overall Number of Participants Analyzed	444	447
Measure Type: Count of Participants; Unit of Measure: Participants
	191 43.0%	107 23.9%

4. Secondary Outcome

Title	Complete Clearance of All Treatable MC at Week 8
Description	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).
Time Frame	8 Weeks

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SB206	Placebo
Arm/Group Description:	SB206 gel applied topically, once daily for 12 weeks.	Placebo gel applied topically, once daily for 12 weeks.
Overall Number of Participants Analyzed	444	447
Measure Type: Count of Participants; Unit of Measure: Participants
	87 19.6%	52 11.6%

5. Secondary Outcome

Title	Change From Baseline in the Number of All Treatable MC at Week 4
Description	Percent change from Baseline in the number of all treatable MC at Week 4
Time Frame	4 Weeks

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	SB206	Placebo
Arm/Group Description:	SB206 gel applied topically, once daily for 12 weeks.	Placebo gel applied topically, once daily for 12 weeks.
Overall Number of Participants Analyzed	444	447
Least Squares Mean (Standard Error); Unit of Measure: percentage of change from baseline
	-25.5 (2.86)	-9.2 (2.86)

Adverse Events

Time Frame	Baseline visit to end of study visit, 84 days.
Adverse Event Reporting Description	Only TEAE were to be considered.
Arm/Group Title	SB206		Placebo
Arm/Group Description	SB206 gel applied topically, once daily for 12 weeks.		Placebo gel applied topically, once daily for 12 weeks.
All-Cause Mortality
	SB206		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/444 (0.00%)		0/447 (0.00%)
Serious Adverse Events
	SB206		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/444 (0.00%)		1/447 (0.22%)
Injury, poisoning and procedural complications
Supracondylar Fracture of right humerus, closed reduction † 1 [1]	0/444 (0.00%)	0	1/447 (0.22%)	1
1 Term from vocabulary, MedDRA 23.0; † Indicates events were collected by systematic assessment; [1] Moderate/unrelated/hospitalization
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	SB206		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	221/444 (49.77%)		37/447 (8.28%)
General disorders
Application site pain † 1	83/444 (18.69%)	113	23/447 (5.15%)	26
Application site erythema † 1	52/444 (11.71%)	66	6/447 (1.34%)	7
Application site pruritus † 1	33/444 (7.43%)	38	5/447 (1.12%)	5
Application site exfoliation † 1	27/444 (6.08%)	45	0/447 (0.00%)	0
Application site dermatitis † 1	26/444 (5.86%)	28	3/447 (0.67%)	3
1 Term from vocabulary, MedDRA 23.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Cathy White, Vice President, Drug Development Operations
• Organization: Novan
• Phone: 919-485-8080
• EMail: clinical@novan.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Novan, Inc.
• ClinicalTrials.gov Identifier: NCT04535531
• Other Study ID Numbers: NI-MC304
• First Submitted: August 27, 2020
• First Posted: September 2, 2020
• Results First Submitted: November 11, 2022
• Results First Posted: January 26, 2023
• Last Update Posted: January 26, 2023