Cantharidin and Occlusion in Verruca Epithelium

A Phase 2, Open Label Study to Evaluate the Efficacy, Safety and Tolerability of VP-102 in Subjects With Common Warts (Verruca Vulgaris)

Sponsors

Lead Sponsor: Verrica Pharmaceuticals Inc.

Collaborator: Instat Consulting, Inc.
Paidion Research, Inc.
BioClinica, Inc.
ALMAC Clinical Services

Source Verrica Pharmaceuticals Inc.
Brief Summary

This is a Phase 2, open label study (Study number VP-102-105; referred to as COVE-1 [Cantharidin and Occlusion in Verruca Epithelium]) to evaluate the efficacy, safety and tolerability of VP-102 treatment in subjects with common warts. This study has two Cohorts.

Detailed Description

The first Cohort (Cohort 1) utilizes a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response.Twenty Subjects (2 years and older) are targeted completing EOS visit in Cohort 1. The second Cohort (Cohort 2) utilizes a treatment interval of 21 days between treatments. Paring of lesions is allowed. Approximately 35 subjects (12 years and older) will be enrolled in Cohort 2. Up to 4 sites will participate in the study.

Overall Status Completed
Start Date 2018-03-27
Completion Date 2019-07-15
Primary Completion Date 2019-05-16
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
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). Treatment Visit Day 1 (Baseline) compared to Day 84 (EOT) Visit.
Secondary Outcome
Measure Time Frame
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 lesions compared at Baseline (Visit 1) to the End of Study Visit (Day 84).
Cohort 2-Change from baseline in the number of treatable warts (baseline and new) at the End of Treatment Visit.(Day 84). Change in the number of lesions compared at Baseline (Visit 1) to the End of Treatment Visit (Day 84).
Cohort 1-Change from baseline in the percent of treatable warts (baseline and new) at the EOS Visit (Day 84). Change in the percent change of lesions compared at Baseline (Visit 1) to End of Study Visit (Day 84).
Cohort 2-Change from baseline in the percent of treatable warts (baseline and new) at the EOT Visit (Day 84) Change in the percent change of lesions compared at Baseline (Visit 1) to End of Treatment Visit (Day 84).
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. Wart clearance compared at Treatment Visit 1 (Baseline) to Treatment Visit Day 14, 28, 42 through EOS (Day 84)
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. Wart clearance compared at Treatment Visit 1 (Baseline) to Treatment Visit Day 21, 42, 63 and EOT (Day 84)
Enrollment 56
Condition
Intervention

Intervention Type: Drug

Intervention Name: VP-102-cantharidin topical film forming solution

Description: VP-102 cantharidin topical film forming solution.

Arm Group Label: Open label

Other Name: Subjects will receive treatment to their warts with VP-102

Intervention Type: Device

Intervention Name: VP-102 Applicator

Description: 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.

Arm Group Label: Open label

Eligibility

Criteria:

Inclusion Criteria: 1. 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. 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). 3. 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) . 4. Have warts that have been present for at least 4 weeks at the time of the baseline visit. 5. Consent to having all warts treated (the physician must also be willing to treat all warts initially present). 6. Be otherwise medically healthy with no clinically significant medical history, physical examination or vital signs as determined by the investigator. 7. 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. 8. Refrain from swimming, bathing or prolonged immersion in water or any liquids until the Study drug is removed. 9. Have the ability, or have a guardian with the ability, to follow study instructions and be likely to complete all study requirements. 10. Agree to use no wart-removing product (prescription or over-the-counter [OTC]) other than the Study drug during the course of the study. 11. 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. 12. Provide written authorization for use and disclosure of protected health information. 13. 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: 1. Are unable to cooperate with the requirements or visits of the study, as determined by the investigator. 2. 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) 3. 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. 4. Have more than 6 common warts at baseline. 5. Present with any verruca plana, mosaiform, filoform, subungual (under the nail), genital or anal warts. In Cohort 2, subjects with periungual warts are also excluded. 6. 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. 7. 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. 8. Have been treated within 14 days with a product that contains cantharidin (topical or homeopathic preparations) for any reason prior to screening. 9. Have received another investigational product as part of a clinical trial within 30 days prior to the first application of the Study drug. 10. Currently have or have a history of epidermodysplasia verrucifomis. 11. 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. 12. Have an active malignancy or are undergoing treatment for any malignancy. 13. 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. 14. 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). 15. 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. 16. 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. 17. Are pregnant or breastfeeding.

Gender:

All

Minimum Age:

2 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Location
Facility:
Cohort 2: Applied Research Center of Arkansas | Little Rock, Arkansas, 72212, United States
Cohort 2: Solutions Through Advanced Research | Jacksonville, Florida, 32256, United States
Cohort 2: The Indiana Clinical Trials Center | Plainfield, Indiana, 46168, United States
Cohort 2: Clarkston Skin Research | Clarkston, Michigan, 48346, United States
Cohort 1-Wake Research Associates | Raleigh, North Carolina, 27612, United States
Location Countries

United States

Verification Date

2019-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Open label

Type: Other

Description: This is an open label study. All subjects will receive treatment to their common warts per protocol with VP-102, cantharidin topical film forming solution, using the VP-102 applicator.

Acronym COVE-1
Patient Data No
Study Design Info

Intervention Model: Sequential Assignment

Intervention Model Description: This study has 2 cohorts. Cohort 1 of the study enrolled 21 subjects and has completed all subject related study activities. Analysis is to be conducted at Day 84. Cohort 2 will utilize 4 sites with an enrollment of approximately 35 subjects. The primary analysis will be conducted at Day 84 with an additional period of follow up out to Day 147.

Primary Purpose: Treatment

Masking: None (Open Label)

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