Phase II Clinical Study, Double Blinded, Multicentric, Controlled Against Placebo, in Parallel Groups, to Evaluate the Efficacy and Safety of a Topical Product Containing Ranpirnase in Genital Warts - HPV
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Size of lesions
研究概览
简要总结
Ranpirnase in topical formulation is an antiviral drug being evaluated for the topical treatment of anogenital warts. The aims of this study is to evaluate the efficacy and safety of a topical formulation of ranpirnase in subjects with genital warts.
详细描述
The study consists of the evaluation of 4 weeks exposure to the study product; designed as randomized, double blinded, against vehicle to study the effects of 1 mg/ml concentration of ranpirnase on anogenital warts.
The dermal reaction are scored on a scale that describes the amount of erythema, edema, and other features indicative of irritation.
The clinical response are be scored on the basis of the percentage of the reduction of the lesions in size and number.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 lesions
- •Accept to follow study instructions / signature of IC
- •Abstain from sexual intercourse for 6 hours after applying the study product during the time of the study.
排除标准
- •Any topical and/or destructive treatments for external genital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrollment (i.e., the randomization visit)
- •Non pregnant. For women in reproductive age it would be required pregnancy test, and the use of double barrier contraceptives.
- •Any of the following conditions:
- •Known allergy to the study product
- •Internal (rectal, urethral) warts that required or were undergoing treatment;
- •A dermatological disease (e.g., psoriasis) or skin condition in the area, which may interfere with the evaluation.
- •Imiquimod 5% cream (Aldara®)
- •Any marketed or investigational HPV vaccines
- •Sinecatechins (Veregen)
- •Interferon or interferon inducers
- •Cytotoxic drugs
- •Immunomodulators or immunosuppressives
- •Oral or parenteral corticosteroids (inhaled/intranasal steroids are permitted)
- •Oral antiviral drugs (with the exception of HAART, oral acyclovir and acyclovir related drugs) for suppressive or acute therapy herpes; or oseltamivir for prophylaxis or for influenza)
- •Topical antiviral drugs (including topical acyclovir and acyclovir related drugs) in the areas under treatment
- •Podophyllotoxin/Podofilox in the treatment areas
- •Any topical prescription medications in the treatment areas
- •Dermatologic procedures or surgery in the treatment areas
研究组 & 干预措施
Treatment group
1 mg/ml solution of ranpirnase applied twice daily
干预措施: Ranpirnase (Drug)
Control
Vehicle - innert gel
干预措施: Vehicle (Drug)
结局指标
主要结局
Size of lesions
时间窗: Up to 60 days
The primary endpoint is the percentage change from baseline in total area of lesions at Week 8
次要结局
- Number of lesions(Up to 60 days)