COVE-3: A Phase 3, Double-blind, Randomized, Vehicle-controlled Study to Evaluate the Efficacy and Safety of YCANTH (VP-102/TO-208) in Subjects With Common Warts (Verruca Vulgaris)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 22
研究概览
简要总结
This is a Phase 3, double-blind, randomized, vehicle-controlled study (Study number VP-CW-302; referred to as COVE-3 [Cantharidin and Occlusion in Verruca Epithelium]) to evaluate the efficacy and safety of YCANTH (VP-102/TO-208) treatment in subjects with common warts.
详细描述
Methodology:
This Phase 3, double-blind, randomized, vehicle-controlled study (Study number VP-CW-302; referred to as COVE-3 [Cantharidin and Occlusion in Verruca Epithelium 3]) includes a Screening Period of up to 60 days, followed by a 75-day Treatment Period, and a 63-day Follow-up Period.
Treatments:
Treatment Visit 1 (Day 1), the day of the first application of study drug (YCANTH [VP-102/TO-208] or Vehicle), may occur on the same day as the Screening Visit. Dermatologic examination, wart measurements, location of all treatable common warts, and evaluation of response to treatment (ERT; as defined in Assessments and procedures) must be repeated if the Screening Visit and Treatment Visit 1 do not coincide. YCANTH (VP-102/TO-208) or Vehicle will be applied by the Investigator or qualified member of the research team. Study drug will be applied to treatable common warts, including an approximate 1 to 2 mm margin of healthy, surrounding skin. Warts are to be treated, then covered with occlusive tape (occlusive tape with similar properties should be used across all clinical sites) that will remain in place overnight and be removed just before the 24 hour evaluation of response to treatment (ERT).
Before application of study drug, wart paring, if necessary, will be completed. If adherent scale is not present, study drug can be applied without paring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates will be included in the study if they:
- •Are male or female patients ≥ 2 years of age.
- •Are immunocompetent.
- •Have a minimum of 1 treatable common wart (verruca vulgaris) of any size and height:
- •Common warts are considered treatable if they are located anywhere on the body, except for the following excluded areas: the eye area (including eyelids), lips, oral cavity, nasal cavity, inside of the ears, soles of the feet (plantar warts), subungual spaces (ie, under the fingernail or toenail), or the anogenital area (warts within 10 mm of a mucosal surface should not be treated).
- •Common warts located in excluded areas (warts within 10 mm of a mucosal surface) will not be treated or evaluated in this study. Warts that are genital, plantar, or anal are not considered common warts and are thus excluded from treatment and evaluation in this study. A subject will not be excluded from the study if they have these types of warts, but the subject must also have warts that meet the inclusion criteria. • If treatment of these excluded wart types is required during the study, it should be limited to destructive therapy such as cryosurgery and warts cannot be within 10 mm of any warts that are under study.
- •Have no systemic or dermatologic disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs.
- •Agree to refrain from swimming, bathing, or prolonged immersion in water or any liquids until the study drug is removed after each treatment.
- •Have the ability, or have a parent/guardian with the ability, to follow study instructions and the willingness to complete all study requirements.
- •Agree not to use any wart-removing product (prescription or over-the-counter) other than the study drug during the course of the study, with the exception of circumstances allowed under Inclusion Criterion 3b.
- •Provide written informed consent or assent in a manner approved by the IRB and/or have a parent/guardian provide written informed consent as evidenced by the signature on an IRB approved assent/consent form. Subjects who turn 18 years of age (or legal age per state or country) during the study will be required to re-consent to remain on the study.
- •Provide written authorization for use and disclosure of protected health information (per state and/or country requirements).
- •If participating in the optional photographic assessment, agree to allow photographs of treatable common warts to be taken at selected visits by the research team.
排除标准
- •Candidates will be excluded from the study if they:
- •Are unable to cooperate with the requirements or visits of the study, as determined by the Investigator.
- •Have any warts present at Baseline in an allowed anatomic location that the subject, parent/guardian, or Investigator is unwilling to treat.
- •Plantar warts and external genital warts will not be included in this study, in addition, subungual warts and warts within 10 mm of a mucosal surface will not be included in this study due to their anatomical location and complex treatment modalities.
- •Are systemically immunosuppressed or have taken required systemic immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days before enrollment or such treatment is planned to be required during the course of the study. Routine use of local (eg, topical, inhaled, intranasal) corticosteroids and episodic use of systemic medications to treat conditions arising 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 (eg, human immunodeficiency virus, systemic lupus erythematosus, viral hepatitis, uncontrolled diabetes).
- •Have had any previous treatment (including an investigational agent in a clinical trial) of common warts, including but not limited to the use of cantharidin, imiquimod, antivirals, retinoids, topical salicylic acid, lactic acid, hydrogen peroxide, trichloroacetic acid, pulse dye laser, iodine-based or nitric oxide-based therapies, oral cimetidine, coix seed, intralesional immunotherapy, curettage, or freezing of warts in the 30 days before treatment.
- •Have more common warts, or wart area, to be treated than can be adequately covered with the contents of 2 study drug applicators, as determined by total wart surface area. Each applicator can cover approximately 1500 mm2 for a total of approximately 3000 mm2 using the 2 study drug applicators.
- •Immunizations (eg, flu shots) may be administered throughout the study, but not within 5 days before or after any treatment with study drug and will be recorded as concomitant therapies in the eCRF.
- •Have received any investigational product as part of a clinical trial NOT related to the treatment of common warts within 30 days before the first application of the study drug.
- •Have epidermodysplasia verruciformis.
- •Have an active malignancy or are undergoing treatment for any malignancy other than basal cell carcinoma.
- •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 (eg, subjects who required hospitalization in the 2 months before screening for an acute or chronic condition including alcohol or drug abuse), as determined by the Investigator.
- •Are sexually active or may become sexually active and are unwilling to practice a highly effective method of birth control (eg, combination of condoms and foam; oral contraceptives; intrauterine device with or without hormone release; transdermal, injectable, or intravaginal contraception). Withdrawal is not an acceptable method of birth control. Females who have reached menarche must have a negative urine pregnancy test at each visit before treatment with study drug.
- •Are pregnant or breastfeeding.
研究组 & 干预措施
Vehicle (US) / Vehicle (Japan)
US: Topical solution, which is a light violet to dark purple, slightly viscous liquid.
Japan: Topical solution, which is clear to yellow, slightly viscous liquid.
No active drug/glass ampule within an applicator. Each applicator contains 0.45 mL without active cantharidin.
Administered Topical/every 21 (± 4) days. All treatments will take place within a 75-day period.
干预措施: Vehicle (US) / Vehicle (Japan) (Combination Product)
VP-102 (US) / TO-208 (Japan)
US: Topical solution, which is a light violet to dark purple, slightly viscous liquid.
Japan: Topical solution, which is clear to yellow, slightly viscous liquid.
0.7% (each mL contains 7 mg of cantharidin)/ glass ampule within an applicator. Each applicator contains 0.45 mL of 0.7% w/v cantharidin.
Administered Topical/every 21 (± 4) days. All treatments will take place within a 75-day period.
干预措施: VP-102 (US) / TO-208 (Japan) (Combination Product)