Cold Sores
Conditions
Keywords
Herpes, Oral herpes simplex, Oral ulcer
Brief 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).
Interventions
DEVICEProfilm Cold Sores
The treatment will consist of daily applications of the product as soon as the first symptoms of an outbreak appear, and until the outbreak subsides, as follows: application every 8 hours, with the possibility of shortening the interval to 6 hours if needed (a maximum of 3-4 applications).
Sponsors
Dr. Goya Análisis, SL.
Centro Médico Complutense Grupo Virtus
i+Med S.Coop.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intrasubject control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirm the effectiveness of the treatment in terms of pain relief, using an EVA scale. | At baseline, in 24 hours, in 3 days, in 7 days and in 14 days. | Pain relief as a significant clinical improvement in the EVA Pain score from 0 to 10 (where 0 = no pain and 10 = unbearable or severe pain) after treatment. |
| Serious adverse events. | Through study completion, apprroximately 2 weeks. | Evaluate the safety of the treatment related to the product, in terms of the incidence of serious adverse events during the treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the treatment based on lesion size. | At baseline, in 24 hours, in 3 days, in 7 days and in 14 days. | A decrease of at least 50% of the maximum size reached, at the midpoint of the treatment (7 days). Exploratory analysis at 14 days or at the end of the outbreak, with at least an 80% reduction in the extent of the lesion |
Other
| Measure | Time frame | Description |
|---|---|---|
| Global treatment assessment by participants | At the conclusion of the study, approximately 2 weeks later. | On a scale from 0 to 10 (where 0 = no response or not satisfied at all, and 10 = excellent response or exceptionally satisfied) after the treatment. A score of ≥ 6 out of 10 will indicate responders. |
| Clinical assessment of the skin condition by a specialist. | At baseline, in 24 hours, in 3 days, in 7 days and in 14 days. | Clinical assessment of the skin condition (localization of the vesicles, extent or lack thereof to the skin, observation of other related factors: fever, muscle pain, lymph node inflammation...). |
| Changes in the intensity and severity of the symptoms. | At baseline, in 24 hours, in 3 days, in 7 days and in 14 days. | Assessment of the severity-intensity of symptoms (pain, itching, burning or stinging, and tingling) perceived with a score ≤ 4 points on a 0 to 10 scale. (Where 0 = no symptoms / 10 = severe symptoms). |
| Mean duration of the episode | Through study completion, apprroximately 2 weeks | Mean duration of the episode (MDE) due to cold sores (≤ 7 days) |
| Mild adverse events. | Through study completion, apprroximately 2 weeks. | Evaluate the incidence of other mild and transient adverse events related to the product. |
| Degree of protection-hygiene provided by the treatment. | At the conclusion of the study, approximately 2 weeks later. | It is done using a scale from 0 to 10, where 0 = no protection and 10 = full protection. A score of ≥ 5 on a scale from 0 to 10 at the end of the treatment will indicate effectiveness. |
| Evaluation of the visibility-noticeability of the outbreak. | At the conclusion of the study, approximately 2 weeks later. | It will be done using a scale where a score of ≤ 5 on a scale from 0 to 10 at the end of the treatment will indicate effectiveness (where 0 = not noticeable at all and 10 = highly noticeable). |
Countries
Spain
Outcome results
None listed