Herpes labialis MedDRA version: 20.0 Level: PT Classification code 10019948 Term: Herpes simplex System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Lipovir®
Product Name: Not applicable
Product Code: Not applicable
Pharmaceutical Form: Gel
INN or Proposed INN: ACICLOVIR S
Sponsors
Laboratorios Ojer Pharma S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the local tolerability and acceptability of Lipovir® Gel compared to Zovirax® Cream in patients with RHL, according to participants’ self-report.; Secondary Objective: - To assess the time to healing of Lipovir® Gel compared to Zovirax® Cream in patients with RHL. - To evaluate the safety of Lipovir® Gel compared to Zovirax® Cream in patients with RHL.. ; Primary end point(s): - Products’ local tolerability self-reported by the participant. - Products’ acceptability as assessed by the participant. ;Timepoint(s) of evaluation of this end point: Throughout all the study (Days 1 to 10, and Visit 2 - end of study) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to healing of the episode as assessed by the participant. - Incidence of general adverse events. ;Timepoint(s) of evaluation of this end point: Throughout all the study (Days 1 to 10, and Visit 2 - end of study) | — |
Countries
Portugal
Contacts
Public ContactBlueclinical Lda
Blueclinical - Investigação e Desenvolvimento em Saúde, Lda
Outcome results
None listed