Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The efficacy
研究概览
简要总结
Phase II, a randomized, double-blind, placebo-controlled clinical trial to evaluate the effectiveness and recurrence of genital warts by combination of CO2 laser and Geniwa gel compared to laser CO2 combined with gel placebo. The clinical trial is conducted at National Dermatology Hospital, Hanoi, Vietnam.
详细描述
Phase II, randomized, controlled, and double blind clinical trial to evaluate the effectiveness and recurrence of genital warts by CO2 laser combined with Geniwa gel treatment. Sixty to eighty patients with a history of genital warts that were resistant to conventional treatments were enrolled in a randomized, double-blind, placebo-controlled study comparing a combination of CO2 laser and Geniwa gel and a combination of CO2 laser and placebo gel.
In the first phase of the study, 60-80 patients were randomly assigned to 2 groups. The first group received a combination of CO2 laser and Geniwa gel for 6 weeks. The second group received a combination of CO2 laser and placebo gel for 6 weeks.
On day 1, after CO2 laser treatment, Geniwa gel (5% alpha lactalbumin-oleic acid) or saline placebo gel was applied to each lesion by investigator. The lesion was covered with a hydrocolloid dressing fastened with Micropore tape for 6 hours-10 hours (during the night). Thereafter, the patients followed the same procedure at home once a day and received a new coded bottle (Geniwa or placebo gel) weekly in the clinic. The genital wart lesions were inspected, measured, and photographed at enrollment, at week 2- 12 during the treatment period, and three to six months after the completion of treatment. The width, length, and height of each lesion were measured with the use of a slide caliper, and the volume of each genital wart lesion was calculated.
If genital warts recur during the first six-week period, CO2 laser treatment will be applied, followed by the continued use of a placebo or Geniwa topical gel. The randomization code was broken after all patients had completed six weeks of the randomly assigned treatment. Geniwa gel is predicted to be superior to placebo. For this reason, patients in both groups were offered six weeks of open-label treatment with Geniwa gel according to the protocol used in the first, randomized phase of the study. The patients participating in the second phase did not know whether they had received Geniwa or placebo during the first treatment period. After the end of open-label treatment with Geniwa, the patients were allowed to use conventional treatment if they wished.
A short-term follow-up investigation was performed approximately 4-6 months after the completion of the second (open-label) treatment period. The sites of treated lesions and possible new lesions were inspected, and the patients were interviewed about the length of time to the resolution of their lesions, about any other treatment they had received for genital warts, and about any other illness or treatment in the intervening period.
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)
盲法说明
A randomized, double-blind, placebo-controlled clinical trial to evaluate the effectiveness and recurrence of genital warts by combination of CO2 laser and Geniwa gel compared to laser CO2 combined with gel placebo.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older.
- •Able to read and understand the Patient Information Sheet and the Informed Consent form.
- •Acceptance in the participation of the essay and signature of the Informed Consent form.
- •Diagnosis of genital and anal warts with clear clinical manifestations.
- •Have undergone at least 2 laser treatments and have experienced recurrence in any location.
- •At least four or more lesions, or a lesion area of at least 0.5 cm2.
排除标准
- •Concomitant sexually transmitted infections such as gonorrhea, syphilis, genital herpes, etc., that have not been cured.
- •Ulceration or suspected malignant transformation of the lesions.
- •Local infections.
- •Pregnant women.
- •Allergies to any component of alpha-lactalbumin-oleic acid gel.
研究组 & 干预措施
Combination of CO2 laser and placebo gel
Placebo gel contains saline gel
干预措施: Placebo gel (Other)
Combination of CO2 laser and Geniwa gel
Geniwa gel contains 5% alpha lactalbumin-oleic acid complexes
干预措施: Geniwa gel (Drug)
结局指标
主要结局
The efficacy
时间窗: 1-12 weeks of treatment
Number of patients with complete elimination of all genital warts lesions during the 12-week treatment period. Patients who achieved complete elimination of genital warts during treatment were assessed for recurrence within 4-6 months after the last treatment. The lession area is measured in cm2 or mm2.
The Safety
时间窗: 1-12 weeks of treatment
Percentage of patients experiencing at least one adverse event, percentage of patients experiencing at least one serious adverse event, the number of adverse events in each group.
次要结局
- Partial elimination(1-12 weeks of treatment)
- New lesions(1 week-6 months)
- Recurrence rate(4-6 months after the last treatment)
- HPV clearance criteria(4-6 months after the last treatment)