None listed
Conditions
Brief summary
The aim of this clinical trial is to test the effectiveness of a topical treatment on facial cold sores (herpes simplex labialis): whether it reduces the duration of healing and the amount of pain and other symptoms. A minimum of 292 male and female participants in Australia and New Zealand, aged from 18 to 65 years, will be randomly assigned to receive either a placebo or a medically approved topical treatment. Participants will complete an initial study 'visit' with an investigator either at a pharmacy or by phone. The first visit will be cover an initial assessment and treatment. Participants will report symptoms and healing progression in an on-line daily diary which researchers will monitor for reports of adverse side effects. A second visit will be conducted by phone for comparative assessment once the participant has healed or 14 days have passed.. We expect the primary outcome to be a reduction in the duration of the cold sore compared to the placebo controlled group.
Interventions
One topical application (0.5-0.7ml) of the intervention will be applied to the lesion. The application will be performed by the participant, either at home or at the pharmacy. The application will always be guided by a study investigator either by phone or in person.
This single application of the topical treatment containing Hypericum perforatum (St John's Wort), Calendula officinalis (Calendula) and copper sulfate will be applied within 48 hours of the first prodromal symptoms or first clinic
One topical application (0.5-0.7ml) of the intervention will be applied to the lesion. The application will be performed by the participant, either at home or at the pharmacy. The application will always be guided by a study investigator either by phone or in person. This single application of the topical treatment containing Hypericum perforatum (St John's Wort), Calendula officinalis (Calendula) and copper sulfate will be applied within 48 hours of the first prodromal symptoms or first clinical signs of herpes simplex labialis. There is only one single dose of the topical treatment applied with no further applications of the treatment during the 14 days or until the skin returns to normal. Participants will record in a daily online diary, cold sore progression, levels of pain and symptoms and any adverse events during the treatment period.
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
- Females and males from the general population. (Pre-allocation criteria) - Aged 18-65 years. (Pre-allocation criteria) - Previous clinical history of HSL, with at least 3 prior episodes. (Pre-allocation criteria) - Onset of prodromal or clinical symptoms of HSL within the past 48 hours. - Primary lesion is within 1cm of the lip. - Willing to provide informed consent and adhere to the protocol. (Pre-allocation criteria) - Has internet access (either via a mobile or computer) for completing online forms. (Pre-allocation criteria)
Exclusion criteria
- History of immunodeficiency, immunosuppression or autoimmune disorder (including HIV, rheumatoid arthritis, psoriasis, and systemic lupus erythematosus, inherited immune deficiency, immune suppression for organ transplantation, immune suppression medication for other inflammatory disorders). (Pre-allocation criteria) - Individuals with an acute infection not related to the study condition (current viral infections such as cold and flu). - Use of other antiviral agents (including herbal medications), anti-inflammatory medications or steroids during or within two weeks prior to the treatment period. - Sensitivity to any of the ingredients in the study treatment. (Pre-allocation criteria) - Use of any topical agents (including cosmetics, lip balms, sunscreens, etc.) or cosmetic procedures (such as chemical peels or microdermabrasion) on the prodromal or lesion area during the treatment period. - Mechanical disruption (i.e., scrubbing, lancing, shaving, etc.) of the prodromal area or lesion prohibited during the treatment period. - Female participants who are lactating, pregnant or planning to become pregnant during the next 14 days. (Pre-allocation criteria) - Individuals who have participated in another clinical trial within the last 30 days. - PCR confirmed or probable diagnosis of COVID19 within the last 28 days (Pharmacy recruitment only) - Known contact with PCR confirmed or probable diagnosis of COVID19 within the last 28 days. (Pharmacy recruitment only)
Outcome results
None listed