Post-marketing Study for the Evaluation of the Efficacy and Safety of Profilm Cold Sores
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Confirm the effectiveness of the treatment in terms of pain relief, using an EVA scale.
研究概览
简要总结
Experimental clinical study with a post-marketing, prospective, intra-subject controlled design to evaluate the efficacy and safety of the use of a medical device for the treatment of cold sores, over a maximum period of two weeks (or until the outbreak has resolved).
详细描述
Herpes labialis is a very common skin condition primarily caused by the Herpes simplex virus type 1, which establishes latent infection in the host for life and can periodically reactivate. Episodes can be frequent, painful, long-lasting, and disfiguring, with significant psychological implications for infected patients and their quality of life. A product for this condition should calm and relieve symptoms before the appearance of cold sores, delay or inhibit the progression of the outbreak, and provide a physical-mechanical barrier to prevent contagion. Although formulations for cold sores have improved over time, none are capable of completely eradicating the virus. Therefore, treatment for this condition is mainly symptomatic, alleviating the most uncomfortable symptoms and pain that usually manifest in the early stages of the outbreak.
In this context, the present study focuses on the already marketed product Profilm Herpes Labial. The research consists of a prospective, post-marketing, intra-subject controlled clinical trial to evaluate the efficacy and safety of the use of a medical device for the treatment of cold sores over a maximum period of two weeks. The study population will consist of women and men over 18 years old who wish to relieve the symptoms related to the appearance of cold sores, with the sample size being statistically established in advance. The subjects are volunteers from the general population, patients from the Complutense Medical Center Virtus Group Dermatology, who present cold sores at the time of recruitment.
The study sample will consist of 35 women and men. They will be recruited consecutively, and the treatment will be followed for two weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •nclusion Criteria:
- •Male / female / aged 18 years or older.
- •Presence of a herpes labial outbreak, regardless of the number of days since its appearance.
- •At least 30 days have passed since the last episode.
- •Willingness to return for all study-related visits.
- •Sufficient willingness and ability, as judged by the investigator, to respond to the questionnaires included in the study.
排除标准
- •Pregnant women or women in the breastfeeding period.
- •Patients undergoing treatment with antiviral medications, hydrocortisone, or other medications.
- •Patients with immunodeficiency diseases, such as acquired immunodeficiency syndrome or altered immune activity in the last 7 days.
- •Patients undergoing other pharmacological therapy forrecurrent herpes labial.
- •Patients with other oral mucosa diseases simultaneously.
- •Known allergy or hypersensitivity to any of the components.
结局指标
主要结局
Confirm the effectiveness of the treatment in terms of pain relief, using an EVA scale.
时间窗: At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
Pain relief as a significant clinical improvement in the EVA Pain score from 0 to 10 (where 0 = no pain and 10 = unbearable or severe pain) after treatment.
Serious adverse events.
时间窗: Through study completion, apprroximately 2 weeks.
Evaluate the safety of the treatment related to the product, in terms of the incidence of serious adverse events during the treatment.
次要结局
- Evaluation of the treatment based on lesion size.(At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.)