A topical cold sore treatment containing St John's Wort, Calendula and Copper

Phase 3

Completed

• Conditions: Herpes Simplex Labialis; Skin - Dermatological conditions; Alternative and Complementary Medicine - Herbal remedies; Infection - Other infectious diseases

• Registration Number: ACTRN12618000890235
• Lead Sponsor: Western Sydney University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-28
• Study Completion: 2022-05-18
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 272

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified