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

The requested reference [747ba5f5bcc3b39520564cab92bf0f15f05bf603] no longer exists in our database. It has been replaced by the current reference: [1111b361c1952535516ae4e522ca686a8c66606a]

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: One topical application (0.5‐0.7ml) of the intervention will be applied to the lesion at the first pharmacy visit. The application will be performed by either the pharmacist or the participant, at the participant's discretion. 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 at the first pharmacy visit 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. CONDITION: Herpes Simplex Labialis PRIMARY OUTCOME: The efficacy of one single topical application (0.5‐0.7ml) of the treatment in the reduction of episode duration of herpes simplex labialis (HSL), measured in days from the onset of HSL symptoms to healed skin. SECONDARY OUTCOME: Participant level of satisfaction of the topical treatment. The survey is designed specifically for this study. The degree of acceptability of the topical treatment. The degree of safety of the topical treatment. The effect of the topical treatment on burning sensation during the disease course of the herpes simplex labialis, assessed for each group, on a four point ordinal scale of 0 ‐ 4; (where 0=not present; 1=mild; 2=moderate; 3=severe) (self‐reported). The effect of the topical treatment on itching sensation during the disease course of the herpes simplex labialis, assessed for each group, on a four point ordinal scale of 0 ‐ 4; (where 0=not present; 1=mild; 2=moderate; 3=severe) (self‐reported). The effect of the topical treatment on pain during the disease course of the herpes simplex labialis, assessed for each group, on a ten point ordinal scale of 0 ‐ 10; (where 0 = no pain and 10 = severe pain) (self‐reported). The effect of the topical treatment on the duration of the herpes simplex labialis wound healing, assessed by the median duration in each group of onset to drying up and healing in days (self‐reported). ; The effect of the topical treatment on the duration of the herpes simplex labialis wound healing, assessed by the median duration in each group of onset to redness in days (self‐reported). ; The effect of the topical treatment on the progression of the HSL to ulcerative vs non‐ulcerative lesions, assessed by the percentage of lesions in each group that progress to an ulcerative stage. This will be self‐reported using a supplied chart with photographs of the stages of wound healing. The effect of the topical treatment on tingling sensation during the disease course of the herpes simplex labialis, assessed for each group, on a four point ordinal scale of 0 ‐ 4; (where 0=not present; 1=mild; 2=moderate; 3=severe) (self‐reported). INCLUSION CRITERIA: ‐ Females and males from the general population. ‐ Aged 18‐65 years. ‐ Previous clinical history of herpes simplex labialis (HSL), with at least 3 prior episodes. ‐ 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. ‐ Has internet access (either via a mobile or computer) for completing online forms
Epistemonikos ID: b0fe36653448526c904256ad024cc9ccaa979e66
First added on: Aug 24, 2024