Cantharidin and Occlusion in Verruca Epithelium | NCT03487549

NCT03487549

Status Module

Sponsor/Collaborators Module

Name	Class
Instat Consulting, Inc.	OTHER
Paidion Research, Inc.	INDUSTRY
BioClinica, Inc.	INDUSTRY
ALMAC Clinical Services

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VP-102	Experimental	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator.	Combination Product: VP-102 Cantharidin topical film forming solution Combination Product: VP-102 Cantharidin, topical film forming solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VP-102 Cantharidin topical film forming solution	Combination Product	VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 14 days between treatments.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOS Visit (Day 84)	Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOS Visit (Day 84).	Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) Visit.
Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84)	Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84).	Compare Treatment Visit 1 (Baseline) to EOT Visit (Day 84)

Secondary Outcomes

Measure	Description	Time Frame
Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOS Visit (Day 84)	Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at the EOS Visit (Day 84).	Change in the number of warts compared at Baseline (Visit 1) to the End of Study Visit (Day 84).

Other Outcomes

Measure	Description	Time Frame
Cohort 1:Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study.	Cohort 1: Percent change from baseline in the number of treatable warts (Baseline and new) from Baseline at Visit 2, Visit 3, Visit 4 and over the duration of the study.	Baseline, Day 14, 28, 42, and 84 (EOS)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be healthy, immunocompetent males or females at least 2 years of age and older for Cohort 1 and 12 years of age and older for Cohort 2.
Present with 1-6 common warts (verruca vulgaris) located anywhere on the body except for the following prohibited areas: the eye area (including eyelids), lips, oral cavity, nasal cavity, inside of the ears, palms of the hands, volar surface of the fingers or toes, under the finger nails (near and on the sides of the nails is allowed for Cohort 1, but warts near and on the sides of the nail (e.g., periungual) are not allowed in Cohort 2), soles of the feet, or the anogenital area. (Warts within 10 mm of a mucosal surface should not be treated).
Have warts that are ≤10 mm in diameter and ≤3 mm in height. (Subjects with warts that are adjacent, touching or clustered may be included so long as the combined diameter in the longest direction does not exceed 10 mm. Individual lesions that are adjacent, touching or clustered should be counted as distinct lesions for the purposes of tracking, inclusion and clearance)(subjects in Cohort 2 can be pared, when necessary and appropriate, prior to evaluating height eligibility) .
Have warts that have been present for at least 4 weeks at the time of the baseline visit.
Consent to having all warts treated (the physician must also be willing to treat all warts initially present).
Be otherwise medically healthy with no clinically significant medical history, physical examination or vital signs as determined by the investigator.
Be free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of Aes.
Refrain from swimming, bathing or prolonged immersion in water or any liquids until the Study drug is removed.
Have the ability, or have a guardian with the ability, to follow study instructions and be likely to complete all study requirements.
Agree to use no wart-removing product (prescription or over-the-counter [OTC]) other than the Study drug during the course of the study.
Provide written informed consent or assent in a manner approved by the institutional review board (IRB) and/or have a parent/guardian provide written informed consent as evidenced by the signature on an IRB approved assent/consent form.
Provide written authorization for use and disclosure of protected health information.
If participating in the optional photographic portion of the study, agree to allow photographs of warts to be taken at each Treatment Visit by the research team and agree to share photos taken at home with the research team via text, email or in-person upload.

Exclusion Criteria:

Are unable to cooperate with the requirements or visits of the study, as determined by the investigator.
Are systemically immunosuppressed or have required, or will require, systemic immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days prior to enrollment or during the course of the study. (Routine use of inhaled or intranasal corticosteroids during the study is allowed)
Have any chronic or acute medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk. (e.g., human immunodeficiency virus, systemic lupus erythematosus, viral hepatitis, uncontrolled diabetes). NOTE: Immunizations and flu shots may be administered throughout the study, but not within 5 days before or after treatment.
Have more than 6 common warts at baseline.
Present with any verruca plana, mosaiform, filiform, subungual (under the nail), genital or anal warts. In Cohort 2, subjects with periungual warts are also excluded.
Have any warts present at baseline in an anatomic location that the subject, parent/guardian or the physician is unwilling to treat or are located in an area that cannot be easily occluded with tape.
Have had any previous treatment of common warts including, but not limited to, the use of cantharidin, antivirals, retinoids, salicylic acid, lactic acid, hydrogen peroxide, candida antigen, diphencyprone, dinitrochlorobenzene, sandalwood oil, thuja oil, squaric acid dibutyl ester, povidone iodine, nitric oxide, curettage or freezing of warts in the past 14 days. In addition, these treatments or any other over-the-counter wart treatment should not be implemented during the course of the study.
Have been treated within 14 days with a product that contains cantharidin (topical or homeopathic preparations) for any reason prior to screening.
Have received another investigational product as part of a clinical trial within 30 days prior to the first application of the Study drug.
Currently have or have a history of epidermodysplasia verruciformis.
Have a history of illness or any dermatologic disorder, which, in the opinion of the investigator, will interfere with accurate assessment of the warts or increase the risk of adverse events.
Have an active malignancy or are undergoing treatment for any malignancy.
Have a history or presence of clinically significant medical, psychiatric, or emotional condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the data.
Have a history or presence of hypersensitivity or an idiosyncratic reaction to the Study drug or related compounds, or drug product excipients (acetone, ethyl alcohol, nitrocellulose, hydroxypropyl cellulose, castor oil, camphor, gentian violet, and denatonium benzoate).
Have a condition or situation that may interfere significantly with the subject's participation in the study (e.g., subjects who required hospitalization in the 2 months prior to screening for an acute or chronic condition including alcohol or drug abuse), at the discretion of the investigator.
Are sexually active or may become sexually active and are unwilling to practice responsible birth control methods. (e.g., combination of condoms and foam, birth control pills, intrauterine device, patch, shot and vaginal ring, etc.). Withdrawal is not an acceptable method of birth control. Females that have reached menarche must have a negative urine pregnancy test at each visit prior to treatment with Study drug.
Are pregnant or breastfeeding.

Contacts/Locations Module

Name	Affiliation	Role
Adnan Nasir, MD	Cohort 1: Wake Dermatology	Principal Investigator
Scott Guenthner, MD	Cohort 2: Indiana Clinical Trials Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cohort 2: Applied Research Center of Arkansas		Little Rock	Arkansas	72212	United States
Cohort 2: Solutions Through Advanced Research

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34286459	Derived	Guenthner S, McFalda W, Kwong P, Eads K, McCafferty M, Rieger J, Glover DK, Willson C, Burnett P, Olivadoti M. COVE-1: A Phase 2, Open-Label Study to Evaluate Efficacy and Safety and the Optimal Regimen of VP-102, a Proprietary Drug-Device Product Containing Topical Cantharidin (0.7% w/v) Under Occlusion for the Treatment of Common Warts. Dermatol Ther (Heidelb). 2021 Oct;11(5):1623-1634. doi: 10.1007/s13555-021-00576-y. Epub 2021 Jul 21.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 1, 2018	Mar 30, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Study participants enrolled into Cohort 1 were not included in Cohort 2. New subjects were enrolled into Cohort 2.

Arm/Group Information

ID	Title	Description
BG000	VP-102 - Cohort 1	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. VP-102 Cantharidin topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 14 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.
BG001	VP-102 - Cohort 2	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of at least 21 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. Paring of lesions was allowed. VP-102 Cantharidin topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0005 BG0018 BG00213
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00037.86± 21.247 BG00137.66± 16.435 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00011 BG00122 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00021 BG00135 BG002

Baseline wart count

Mean

Standard Deviation

Baseline wart count

Title

Denominators

Categories

Title	Measurements
	BG0002.19± 1.569 BG0011.65± 1.098 BG002

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

Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOS Visit (Day 84)

Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOS Visit (Day 84).

ITT Population

Posted

Count of Participants

Participants

Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) Visit.

ID	Title	Description
OG000	Cohort 1	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.

Units	Counts
Participants	OG00021

Title

Denominators

Categories

Title	Measurements
	OG0004

Primary

Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84)

Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84).

ITT Population

Posted

Count of Participants

Participants

Compare Treatment Visit 1 (Baseline) to EOT Visit (Day 84)

ID	Title	Description
OG000	VP-102 - Cohort 2	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

Units	Counts
Participants	OG000

Secondary

Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOS Visit (Day 84)

Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at the EOS Visit (Day 84).

ITT Population

Posted

Mean

Standard Deviation

Number of warts

Change in the number of warts compared at Baseline (Visit 1) to the End of Study Visit (Day 84).

ID	Title	Description
OG000	Cohort 1	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.

Units	Counts
Participants	OG000

Secondary

Cohort 1: Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit (Day 84).

Cohort 1: Assessing the percent change from Baseline in the number of treatable warts (Baseline and new) at the EOT visit (Day 84).

ITT Population

Posted

Mean

Standard Deviation

Percent change

Baseline (Visit 1) to End of Treatment Visit (Day 84).

ID	Title	Description
OG000	Cohort 1	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.

Units	Counts
Participants	OG000

Secondary

Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study

Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Visit 2, Visit 3, Visit 4 and over the duration of the study.

Posted

Count of Participants

Participants

Baseline, Day 14, 28, 42 and 84 (EOS)

ID	Title	Description
OG000	Cohort 1	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.

Units	Counts
Participants	OG000

Secondary

Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit Day 84)

Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at the EOT Visit Day 84).

ITT Population

Posted

Mean

Standard Deviation

change in wart count

Baseline, Day 84 (EOS)

ID	Title	Description
OG000	VP-102 - Cohort 2	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

Units	Counts
Participants	OG000

Secondary

Cohort 2: Change From Baseline in the Percent of Treatable Warts (Baseline and New) at the EOT Visit (Day 84)

Cohort 2: Change from baseline in the percent of treatable warts (baseline and new) at the EOT Visit (Day 84).

ITT Population

Posted

Mean

Standard Deviation

percentage of change in wart count

Baseline (Visit 1) to End of Treatment Visit (Day 84).

ID	Title	Description
OG000	VP-102 - Cohort 2	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

Units	Counts
Participants	OG000

Secondary

Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts, (Baseline and New), at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study

Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts, (baseline and new), at Visit 2, Visit 3, Visit 4 and over the duration of the study.

ITT Population

Posted

Count of Participants

Participants

Baseline, Day 21, 42, 63, and 84 (EOS), 105, 126, and 147

ID	Title	Description
OG000	VP-102 - Cohort 2	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

Units	Counts
Participants	OG000

Other Pre-specified

Cohort 1:Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study.

Cohort 1: Percent change from baseline in the number of treatable warts (Baseline and new) from Baseline at Visit 2, Visit 3, Visit 4 and over the duration of the study.

ITT Population

Posted

Mean

Standard Deviation

Percent change in number of warts

Baseline, Day 14, 28, 42, and 84 (EOS)

ID	Title	Description
OG000	Cohort 1	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.

Units	Counts
Participants	OG000

Other Pre-specified

Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and the EOS Visit

Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at Visit 2, Visit 3, Visit 4 and the EOS Visit.

ITT Population

Posted

Mean

Standard Deviation

change in wart count

Baseline, Day 14, 28, 42, and 84 (EOS)

ID	Title	Description
OG000	Cohort 1	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.

Units	Counts
Participants	OG000

Other Pre-specified

Cohort 1: Proportion of Subjects Exhibiting ≥ 50% Clearance of All Treatable Warts (Baseline and New) at the EOS Visit as Compared to Baseline

Cohort 1: Proportion of subjects exhibiting ≥ 50% clearance of all treatable warts (baseline and new) at the EOS visit as compared to baseline.

ITT Population

Posted

Count of Participants

Participants

Compare Treatment Visit 1 (Baseline) to End of Study (Day 84).

ID	Title	Description
OG000	Cohort 1	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.

Units	Counts
Participants	OG000

Other Pre-specified

Cohort 1-Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOS Compared to Baseline

Cohort 1-Proportion of subjects who respond to treatment defined by a ≥ 50% reduction in total wart area at EOS compared to baseline.

ITT Population

Posted

Count of Participants

Participants

Baseline, Day 14, 28, 42, and 84 (EOS)

ID	Title	Description
OG000	Cohort 1	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.

Units	Counts
Participants	OG000

Other Pre-specified

Cohort 1-Proportion of Subjects Exhibiting Reduction of at Least 1 Treatable Wart From Baseline at Visit 2, Visit 3, Visit 4 and at the EOS Visit (Day 84)

Cohort 1-Proportion of subjects exhibiting reduction of at least 1 treatable wart from baseline at Visit 2, Visit 3, Visit 4 and at the EOS Visit (Day 84).

ITT Population

Posted

Count of Participants

Participants

Baseline, Day 14, 28, 42, and 84 (EOS)

ID	Title	Description
OG000	Cohort 1	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.

Units	Counts
Participants	OG000

Other Pre-specified

Cohort 2: Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Visit 2, Visit 3, Visit 4 and Over Duration of the Study.

Cohort 2: Intent to Treat population Cohort 2-Percent reduction of all treatable warts (baseline and new) from baseline at Visit 2, Visit 3, Visit 4 and over duration of the study.

ITT population

Posted

Mean

Standard Deviation

percentage of change in wart count

Baseline to Treatment Visits 2 (Day 21), 3 (Day 42), 4 (Day 63) through the End of Treatment (Day 84).

ID	Title	Description
OG000	VP-102 - Cohort 2	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

Units	Counts
Participants	OG000

Other Pre-specified

Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4 and the EOT Visit (Day 84)

Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4 and the EOT Visit (Day 84).

ITT Population

Posted

Mean

Standard Deviation

change in wart count

Baseline, Day 14, 28, 42, and 84 (EOS)

ID	Title	Description
OG000	VP-102 - Cohort 2	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

Units	Counts
Participants	OG000

Other Pre-specified

Cohort 2: Proportion of Subjects Exhibiting ≥ 50 % Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84) as Compared to Baseline

Cohort 2: Proportion of subjects exhibiting ≥ 50 % clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84) as compared to baseline.

ITT Population

Posted

Count of Participants

Participants

Baseline to Day 84 (EOT)

ID	Title	Description
OG000	VP-102 - Cohort 2	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

Units	Counts
Participants	OG000

Other Pre-specified

Cohort 2: Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOT Compared to Baseline

Cohort 2: Proportion of subjects who respond to treatment defined by a ≥ 50% reduction in total wart area at EOT compared to baseline.

ITT Population

Posted

Count of Participants

Participants

Baseline to EOT (Day 84)

ID	Title	Description
OG000	VP-102 - Cohort 2	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

Units	Counts
Participants	OG000

Other Pre-specified

Cohort 2: Proportion of Subjects Exhibiting Reduction of at Least 1 Treatable Wart From Baseline at Visit 2, Visit 3, Visit 4 and at the EOT Visit (Day 84)

Cohort 2: Proportion of subjects exhibiting reduction of at least 1 treatable wart from baseline at Visit 2, Visit 3, Visit 4 and at the EOT Visit (Day 84).

ITT Population

Posted

Count of Participants

Participants

Baseline, Day 14, 28, 42, and 84 (EOS)

ID	Title	Description
OG000	VP-102 - Cohort 2	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

Units	Counts
Participants	OG000

Other Pre-specified

Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Follow-up Visits on Day 105, Day 126 and Day 147

Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at follow-up visits on Day 105, Day 126 and Day 147.

Posted

Count of Participants

Participants

Treatment Visit 1 (Baseline) to each follow-up visit Day 105, Day 126 and Day 147.

ID	Title	Description
OG000	VP-102 - Cohort 2	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

Units	Counts
Participants	OG000

Other Pre-specified

Cohort 2: Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Follow-up Visits on Day 105, Day 126 and Day 147

Cohort 2: Percent reduction of all treatable warts (baseline and new) from baseline at follow-up visits on Day 105, Day 126 and Day 147.

ITT Population

Posted

Mean

Standard Deviation

percentage change from Baseline

Baseline to follow-up visits on Day 105, Day 126 and Day 147

ID	Title	Description
OG000	VP-102 - Cohort 2	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

Units	Counts
Participants	OG000

Other Pre-specified

Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Follow-up Visits on Day 105, Day 126 and Day 147

Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at follow-up visits on Day 105, Day 126 and Day 147.

ITT Population

Posted

Mean

Standard Deviation

change in wart count

baseline to Day 105, Day 126 and Day 147

ID	Title	Description
OG000	VP-102 - Cohort 2	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.	0	21	0	21	20	21
EG001	Cohort 2	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. Subjects were 12 years and older.	0	34	0	35	32	34

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Application site vesicles	General disorders	MedDRA 20.0	Non-systematic Assessment		EG00020 affected21 at risk EG00127 affected34 at risk
Application site pain	General disorders	MedDRA 20.0	Systematic Assessment	Application site pain	EG00020 affected21 at risk EG00126 affected34 at risk
Application site erythema	General disorders	MedDRA 20.0	Systematic Assessment	Application site erythema	EG00013 affected21 at risk EG00119 affected34 at risk
Application site pruritus	General disorders	MedDRA 20.0	Systematic Assessment	Application site pruritus	EG0009 affected21 at risk EG00116 affected34 at risk
Application site scab	General disorders	MedDRA 20.0	Systematic Assessment	Application site scab	EG0008 affected21 at risk EG00120 affected34 at risk
Application site dryness	General disorders	MedDRA 20.0	Systematic Assessment	Application site dryness	EG0006 affected21 at risk EG00113 affected34 at risk
Application site oedema	General disorders	MedDRA 20.0	Systematic Assessment	Application site oedema	EG0004 affected21 at risk EG0016 affected34 at risk
Application site discolouration	General disorders	MedDRA 20.0	Systematic Assessment	Application site discolouration	EG0001 affected21 at risk EG0018 affected34 at risk
Application site exfoliation	General disorders	MedDRA 20.0	Systematic Assessment	Application site exfoliation	EG0000 affected21 at risk EG0014 affected34 at risk
Application site erosion	General disorders	MedDRA 20.0	Systematic Assessment	Application site erosion	EG0000 affected21 at risk EG0013 affected34 at risk
Papilloma viral infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	Papilloma viral infection	EG0000 affected21 at risk EG0013 affected34 at risk

First MCP Posted Date

ID	Term
D014860	Warts
D030361	Papillomavirus Infections
D004266	DNA Virus Infections
D017193	Skin Diseases, Viral
D012874	Skin Diseases, Infectious
D012871	Skin Diseases
D014777	Virus Diseases
D014412	Tumor Virus Infections

Ancestor Terms

ID	Term
D007239	Infections
D017437	Skin and Connective Tissue Diseases
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms