Trials Sponsors Conditions Drugs Pricing

Conditions

Mouth Sores

Keywords

UlcersRecurrent aphthous stomatitisOral ulcersMouth ulcersMouth soresSore

Outcome Measures

Primary Outcomes (2)

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.

Other Outcomes (4)

Mild adverse events.
Through study completion, apprroximately 2 weeks.
Healin time and lesion size.
At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
Global treatment assessment by participants.
At the conclusion of the study, approximately 2 weeks later.
+1 more other outcomes

Study Arms (1)

Profilm Mouth Sores

EXPERIMENTAL

To evaluate the efficacy and safety of the Profilm Mouth Sores for the treatment of mouth sores.

Device: Profilm Mouth Sores

Interventions

Profilm Mouth SoresDevice

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).

Profilm Mouth Sores

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male / female / aged 18 years or older.
Presence of an ulcer on the oral mucosa, regardless of the number of days since its appearance.

Sponsors & Collaborators

Dr. Goya Análisis, SL.
Industrycollaborator
Centro Médico Complutense Grupo Virtus
Othercollaborator
i+Med S.Coop.

Study Sites (1)

Centro Médico Complutense Grupo Virtus

Alcalá de Henares, Madrid, 28805, Spain

MeSH Terms

Conditions

Oral UlcerUlcerStomatitis, Aphthous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsStomatitis

Enrollment

35 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 11, 2024

First Posted

December 18, 2024

Study Start

December 13, 2022

Actual (reported)

Post-marketing Study for the Evaluation of Profilm Mouth Sores

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Other Outcomes (4)

Study Arms (1)

Profilm Mouth Sores

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Other Outcomes (4)

Study Arms (1)

Profilm Mouth Sores

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations