A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo- Controlled, Study of Hyloris Developments' Podofilox Topical Gel 0.5% Compared to Allergan's Condylox® Gel 0.5% in Male and Female Patients With External Anogenital Warts.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Dermax SA
- 入组人数
- 466
- 试验地点
- 17
- 主要终点
- Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas.
研究概览
简要总结
A clinical endpoint bioequivalence (BE) study for a Podofilox Gel 0.5% formulation for the treatment of external anogenital warts in comparison to Condylox® Gel 0.5% that follows the study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and Drug Administration (FDA) Draft Guidance for Podofilox recommendations
详细描述
This is a multicenter, parallel group, randomized, double-blind, placebo-controlled, trial with clinical endpoint comparing Podofilox Topical Gel 0.5% to Condylox® Gel 0.5% and a matching placebo. The study will be conducted among adult male and female patients with external anogenital warts. The Investigator will assess vital signs and perform physical examination identifying any clinically significant abnormalities. Laboratory samples will be collected, including HIV, Hepatitis B&C, and urine pregnancy tests (UPT) for women of childbearing potential. The Investigator will confirm the diagnosis of External Anogenital Warts (EAW) and the absence of contraindications specified in the exclusion criterion 4 during the visual examination. The biopsy of skin lesions will be performed per the discretion of the Investigator for microscopic verification of the diagnosis of EAWs if any doubts of the diagnosis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent prior to participating in this study.
- •Male or female subjects, aged 18-65 inclusive, with a clinical diagnosis of external anogenital warts (i.e., perianal warts and/or external genital warts), including two or more distinct external genital warts, and wart area that is equal or less than 10 cm
- •Histological confirmation should be obtained if there is any doubt of the diagnosis.
- •Females of childbearing potential may be enrolled if they practice a method of birth control with a reliability of at least 90%.
- •Sexually active study participants must agree to abstain from sexual activity of any kind throughout the treatment period to prevent cross- and reinfection by HPV.
- •Any female subject with childbearing potential has a negative urine pregnancy test at Baseline.
- •Negative HIV test within 4 weeks before Baseline.
排除标准
- •Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Hypersensitivity or intolerance to Podofilox or any component of the formulation.
- •History of previous unsuccessful treatment with any formulation of Podofilox.
- •Wart area that is greater than 10 cm
- •Patients with internal anogenital and mucous membrane warts, Bowenoid papulosis, squamous cell carcinoma, active herpes lesion, or other skin abnormalities of treatment area, such as eczema, or skin that had not healed following surgery (cryosurgery, laser ablation or similar).
- •Primary or secondary immunodeficiency.
- •Known presence of diabetes type I or II.
- •Local irritation in any treatment area that would interfere with treatment.
- •Use within 4 weeks prior to baseline of any: 1) treatment for anogenital warts, 2) systemic corticosteroids, or 3) systemic immunosuppressive drug.
- •Any medical or surgical condition in the judgment of the Investigator that may interfere with the assessment of efficacy or safety, or pose a risk to the subject.
- •Patients known to abuse alcohol and/or drugs, or with a history of chronic alcohol or drug abuse that may result in protocol noncompliance.
- •Received another investigational drug, device or biologic within 90 days prior to the start of Screening or has planned to participate in another clinical trial while enrolled in this study.
- •Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study
- •Employee (or employee's family member) of the research center or private practice, CRO or Sponsor, or subjects who have a conflict of interest.
- •Subjects living (e.g., siblings, spouses, relatives, roommates) in the same household cannot be enrolled in the study at the same time.
- •Previous enrollment in this study, current enrollment in this study at another participating site or current enrollment in another study (in parallel to this study) at another clinical research site.
研究组 & 干预措施
Podofilox Gel 0.5 %
Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles
干预措施: Podofilox Gel 0.5% (Drug)
Condylox Topical Gel 0.5%
Condylox Topical Gel 0.5% twice daily, three days following by four days of discontinuation, up to four cycles
干预措施: Condylox Topical Gel 0.5% (Drug)
Placebo Gel
Subjects in this arm will receive a vehicle that matches the test product, except for the inclusion of the active ingredient
干预措施: Placebo Gel (Drug)
结局指标
主要结局
Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas.
时间窗: 28 days.
The primary endpoint is the Number and Percentage of subjects in the per protocol (PP) population with "treatment success" defined as "total disappearance of all warts within all treated areas".
次要结局
- Analysis of Safety Variables Will be Based on All Adverse Events (AE).(The AE reporting period for this study begins with the signature of the Informed Consent Form and, for unresolved AEs, ends 30 days following the last study medication application, a total of up to 65 days.)
- Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.(28 days (at visit 6))