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| Name | Class |
|---|---|
| Dr. Goya Análisis, SL. | INDUSTRY |
| Centro Médico Complutense Grupo Virtus | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Profilm Cold Sores | Experimental | Participants will use Profil Cold Sores daily as soon as the first symptoms of a new outbreak appear and until the outbreak is resolved. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Profilm Cold Sores | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Confirm the effectiveness of the treatment in terms of pain relief, using an EVA scale. | 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. | At baseline, in 24 hours, in 3 days, in 7 days and in 14 days. |
| Serious adverse events. | Evaluate the safety of the treatment related to the product, in terms of the incidence of serious adverse events during the treatment. | Through study completion, apprroximately 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the treatment based on lesion size. | 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 | At baseline, in 24 hours, in 3 days, in 7 days and in 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the intensity and severity of the symptoms. | 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). | At baseline, in 24 hours, in 3 days, in 7 days and in 14 days. |
nclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Médico Complutense Grupo Virtus | Alcalá de Henares | Madrid | 28805 | Spain |
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| ID | Term |
|---|---|
| D006560 | Herpes Labialis |
| D006561 | Herpes Simplex |
| D013283 | Stomatitis, Herpetic |
| D019226 | Oral Ulcer |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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Intrasubject control
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| Degree of protection-hygiene provided by the treatment. |
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. |
| At the conclusion of the study, approximately 2 weeks later. |
| Evaluation of the visibility-noticeability of the outbreak. | 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). | At the conclusion of the study, approximately 2 weeks later. |
| Global treatment assessment by participants | 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. | At the conclusion of the study, approximately 2 weeks later. |
| Clinical assessment of the skin condition by a specialist. | 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...). | At baseline, in 24 hours, in 3 days, in 7 days and in 14 days. |
| Mild adverse events. | Evaluate the incidence of other mild and transient adverse events related to the product. | Through study completion, apprroximately 2 weeks. |
| Mean duration of the episode | Mean duration of the episode (MDE) due to cold sores (≤ 7 days) | Through study completion, apprroximately 2 weeks |
| D017193 |
| Skin Diseases, Viral |
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013280 | Stomatitis |