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Completed

NCT Number: NCT06734728

Post-marketing Study for the Evaluation of Profilm Cold Sores

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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Key information

Conditions

Cold Sores DNA Virus Infections Herpes Labialis Herpes Simplex Herpesviridae Infections Infections Lip Diseases Mouth Diseases Oral Ulcer Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Stomatitis Stomatitis, Herpetic Stomatognathic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Médico Complutense Grupo Virtus

Alcalá de Henares, Madrid, 28805, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 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.

  2. Serious adverse events.

    Time frame: 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 outcomes

  1. Evaluation of the treatment based on lesion size.

    Time frame: 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 outcomes

  1. Changes in the intensity and severity of the symptoms.

    Time frame: 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).

  2. Degree of protection-hygiene provided by the treatment.

    Time frame: 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.

  3. Evaluation of the visibility-noticeability of the outbreak.

    Time frame: 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).

  4. Global treatment assessment by participants

    Time frame: 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.

  5. Clinical assessment of the skin condition by a specialist.

    Time frame: 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...).

  6. Mild adverse events.

    Time frame: Through study completion, apprroximately 2 weeks.

    Evaluate the incidence of other mild and transient adverse events related to the product.

  7. Mean duration of the episode

    Time frame: Through study completion, apprroximately 2 weeks

    Mean duration of the episode (MDE) due to cold sores (≤ 7 days)

Sponsors and collaborators

Lead sponsor

i+Med S.Coop.

Industry

Collaborators

  • Centro Médico Complutense Grupo Virtus
  • Dr. Goya Análisis, SL.

Registry information

Official study title

Post-marketing Study for the Evaluation of the Efficacy and Safety of Profilm Cold Sores

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 16, 2024
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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