An open-label study to investigate the local tolerability and acceptability of Lipovir® Gel (Acyclovir 5%) compared to Zovirax® Cream (Acyclovir 5%) on patients with Recurrent Herpes Labialis - Not applicable

aboratorios Ojer Pharma S.L.0 个研究点目标入组 60 人开始时间: 2017年4月24日最近更新: 2019年12月10日

研究概览

暂无简介。

•1. Free written informed consent prior to any procedure required by the study.
•2. Age =18 years at the time of signing the informed consent.
•3. Able to read, understand, and sign the informed consent document.
•4. Able to understand and follow the study procedures, including complete the study diary.
•5. Recurrent Herpes Labialis (RHL), as defined by at least one previous episode of Herpes labialis requiring treatment.
•6. Experiencing symptoms (e.g. pain, burning, tingling and itching) and signs consistent with a new episode of RHL.
•7. Onset of current Herpes Labialis episode within the previous 36 hours.
•8. No prior antiviral medication for the current episode.
•9. Agrees to abstain from any:
•a) topical or systemic antiherpetic agents from screening/baseline until completion of the study; and
•b) topical treatments in the lesion area (cosmetics, lip balms, sun screens, etc.) during the treatment period until healing occurs; and
•c) mechanical disruption of the prodromal area or lesion (i.e., scrubbing, lancing, shaving the area, etc.).
•10. Willingness to accept and comply with study requirements.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 55
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1. Known hypersensitivity/allergy reaction to the study drug substance or any of the formulations’ excipients.
•2. Known hypersensitivity to valaciclovir.
•3. Known clinically significant immune system disorder.
•4. Treated within the previous 7 days with antiviral medication, hydrocortisone or other medications that may affect
•immune activity.
•5. Concurrent oral mucosal diseases.
•6. Participation in any clinical trial within the previous 28 days.
•7. If female, she declares to be pregnant or breast-feeding.
•8. Unlikely to co-operate with the requirements of the study.
•9. Any other condition that the Investigator considers to make the subject unsuitable for the study.

发起方

aboratorios Ojer Pharma S.L.