CompletedNot Applicable

Post-marketing Study for the Evaluation of Profilm Cold Sores

Spain35 participantsStarted 2022-12-13

Plain-language summary

Experimental clinical study with a post-marketing, prospective, intra-subject controlled design to evaluate the efficacy and safety of the use of a medical device for the treatment of cold sores, over a maximum period of two weeks (or until the outbreak has resolved).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

nclusion Criteria: * Male / female / aged 18 years or older. * Presence of a herpes labial outbreak, regardless of the number of days since its appearance. * At least 30 days have passed since the last episode. * Willingness to return for all study-related visits. * Sufficient willingness and ability, as judged by the investigator, to respond to the questionnaires included in the study. Exclusion Criteria: * Pregnant women or women in the breastfeeding period. * Patients undergoing treatment with antiviral medications, hydrocortisone, or other medications. * Patients with immunodeficiency diseases, such as acquired immunodeficiency syndrome or altered immune activity in the last 7 days. * Patients undergoing other pharmacological therapy forrecurrent herpes labial. * Patients with other oral mucosa diseases simultaneously. * Known allergy or hypersensitivity to any of the components.

What they're measuring

Confirm the effectiveness of the treatment in terms of pain relief, using an EVA scale.

Timeframe: At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.

Serious adverse events.

Timeframe: Through study completion, apprroximately 2 weeks.

Trial details

NCT IDNCT06734728

Sponsori+Med S.Coop.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-15

View on ClinicalTrials.gov More Cold Sores trials