Herpes Labialis
Conditions
Interventions
This is an open-label, prospective, single-arm clinical study. A total of 45 individuals who meet the eligibility criteria will be allocated to a single intervention group. Both the researchers assess
Sponsors
Universidade de São Paulo
Universidade de São Paulo
Eligibility
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants aged 14 and older, provided they are accompanied and authorized by a legal guardian, or are over 18 years of age; male and female; individuals with any health condition, with no restrictions related to medical history (except allergies to components of the therapeutic intervention formula); p resenting prodromal signs and symptoms and contacting the researchers within the first 48 hours; availability and interest in adhering to the research protocol; previous clinical history of at least one episode of herpes lesion(s); absence of use of antivirals (systemic and topical) in the 15 days preceding the clinical phase of the study; absence of use of topical products (makeup, moisturizers, creams, and sunscreens) near and on the site of herpes lesions during the clinical phase; internet access (either via cell phone or computer) to complete the research questionnaires.
Exclusion criteria
Exclusion criteria: Participation in a different clinical study related to the treatment of cold sores and involving the use of antiviral and analgesic drugs (limited adherence to the study protocol); use of analgesics and anti-inflammatories in the prodromal phase; allergy to components of the therapeutic intervention formula and to local anesthetics (prilocaine and lidocaine); dry desquamation stage (hard crust); planned use of additional medications for cold sores during the study period; fever above 38°C during the clinical phase of the study; pregnant or lactating women; individuals who have undergone lip filler procedures (with any drug) in the last 12 months prior to the clinical phase of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of the participants' lip thicknesses will be performed using a digital caliper and ImageJ software to determine whether there is a correlation between this anatomical characteristic and the manifestation of lesions. Furthermore, the therapeutic efficacy of the formulation will be assessed by assessing the size and stage of the lesions throughout the treatment at two different time points. | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigating the impact of herpetic lesions on participants' quality of life and level of satisfaction with the formulation, which will be measured through the application of questionnaires. | — |
Countries
Brazil
Contacts
Public ContactCarolina de Araujo
Faculdade de Odontologia de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed