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| Name | Class |
|---|---|
| Dr. Goya Análisis, SL. | INDUSTRY |
| Centro Médico Complutense Grupo Virtus | OTHER |
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The study aims to assess the effect of Profilm Mouth Sores treatment for relieving symptoms caused by mouth sores. It will involve 35 participants and last around 14 days or until the sores heal, with three daily applications. A dermatology specialist will evaluate the results through tests and examinations of the treated area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Profilm Mouth Sores | Experimental | To evaluate the efficacy and safety of the Profilm Mouth Sores for the treatment of mouth sores. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Profilm Mouth Sores | Device | Daily applications of the product as soon as a mouth sore appears, until its complete disappearance or healing, 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. | For the evaluation of effectiveness, a 0 to 10 EVA scale is used (where 0 = no pain / 10 = severe or unbearable pain). | At baseline, in 24 hours, in 3 days, in 7 days and in 14 days. |
| Serious adverse events. | Evaluate the safety of the treatment, in terms of the incidence of serious adverse events. | Through study completion, apprroximately 2 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mild adverse events. | Evaluate the incidence of other mild and transient adverse events related to the product. | Through study completion, apprroximately 2 weeks. |
| Healin time and lesion size. | Reduction in healing time and extent of the ulcer. Mean healing time of the lesion ≤ 14 days or % of patients with complete healing ≥ 70% at one week. |
Inclusion 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 |
|---|---|
| D019226 | Oral Ulcer |
| D014456 | Ulcer |
| D013281 | Stomatitis, Aphthous |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Post-marketing, prospective, within-subject controlled clinical trial.
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| At baseline, in 24 hours, in 3 days, in 7 days and in 14 days. |
| Global treatment assessment by participants. | Global treatment assessment questionnaires will evaluate the effectiveness of the treatment on a scale from 0 to 10 (where 0 = no response or not satisfied at all, and 10 = excellent response or exceptionally satisfied). | At the conclusion of the study, approximately 2 weeks later. |
| Number, size, and location of sores | Determination of the number, size, and location of sores, as well as difficulty eating and/or drinking. | At baseline, in 24 hours, in 3 days, in 7 days and in 14 days. |
| D013280 | Stomatitis |