Study to Evaluate Using a Cold Sore Patch to Treat Herpes Labialis

Study Overview
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Brief Summary
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The primary objective of this study was to evaluate the safety and performance of a cold sore patch for the treatment of herpes labialis.

Detailed Description
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This was an open, single-center multi-site, non-comparative study to evaluate the safety and performance of CSP-Night under actual-use conditions in subjects with herpes labialis of the lips and/or perioral skin. A sufficient number of subjects were screened to ensure that 45 subjects experienced and treated a cold sore outbreak in the course of 14 weeks. Subjects were instructed to initiate therapy within approximately 1 hour of onset of their first sign or symptom. Treatment was continued until the lesion healed, or for a maximum of 10 days. All subjects were expected to return to the study center for clinical assessments within 24 hours and 48 hours after initiating treatment, and every other day thereafter, with a final visit at Day 10 or at the time of completion/discontinuation if before Day 10. Diaries were completed each day, beginning upon initiation of therapy and continuing until study completion/ discontinuation, and included information on study product applications and compliance.

Official Title
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Study to Evaluate the Safety and Performance of Compeed® Cold Sore Patch Night in the Treatment of Herpes Labialis

Conditions
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Herpes Labialis

Intervention / Treatment
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* Device: Cold Sore Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females or males subjects, at least 18 to 70 years of age, in good general health History of recurrent herpes labialis (HSV-1) on the lips and/or perioral skin, with lesions typically manifesting as classical lesions (i.e., episodes progressing to vesicle, ulcer, and/or crust stages). Based on history, subject is considered likely to experience a cold sore outbreak within a time period of 2-3 months Individuals who were willing and able to provide informed consent Willing to stop all other treatment of this condition during the test period, including creams, tablets and other treatments Agrees not to use any topical product (e.g., cosmetics, lip balms, sunscreens) on the lesion area other than study medication Individuals who were willing to use the assigned test material for up to 10 consecutive days Individuals who were willing and able to follow the requirements for study participation Women of child bearing potential must agree to use an adequate method of birth control as defined by the protocol. Females who were post-menopausal (for at least 1 year), had a hysterectomy, bilateral ovariectomy or bilateral tubal ligation did not have to have additional birth control methods. Exclusion Criteria: Individuals who were self reported to be pregnant, planning to become pregnant or nursing History of viral infection (e.g., hepatitis, HIV) or other condition likely to require treatment with systemic antiviral or steroid medications during the period of the study Note: Subjects suffering from chronic HSV and/ or have previously treated their herpes virus with systemic medication were permitted to be enrolled in this study. History of any malignant diseases Significant history of liver, kidney, heart, lung or digestive disease that required prolonged hospitalization or out-patient treatment Significant history of blood, nerve, brain or psychiatric disorders that required prolonged hospitalization or out-patient treatment Individuals with uncontrolled diabetes History of dermatologic or other condition(s) that in the judgment of the investigator may affect the course of the cold sore lesion or interfere with the actions of the study treatment or confound the interpretation of the study results Individuals using any analgesics or anti-inflammatory agents during the treatment period Individuals which were taking or had taken within the past 30 days of commencing treatment, systemic antiviral or steroid therapy Individuals which were taking or had taken within the past 7 days of commencing treatment, topical treatments for cold sore Individuals which were taking herbal supplements within 28 days of first dose of study product Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator Individuals with known sensitivity to any ingredients in the test product Individuals participating in another clinical research study, within 30 days of Visit 1 and at any time during the course of the treatment period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: # 1727<br>Cold sore Patch | Device: Cold Sore Patch<br>* All eligible subjects received CSP-Night at Screening Visit 1. Subjects were instructed to initiate therapy within approximately 1 hour of onset of their first sign or symptom. Treatment was continued until the lesion healed, or for a maximum of 10 days. All subjects were expected to return to the study center for clinical assessments within 24 hours and 48 hours after initiating treatment, and every other day thereafter, with a final visit at Day 10 or at the time of completion/ discontinuation if before Day 10.<br>* Other names: Compeed® Cold Sore Patch Night;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician/Investigator's Global Assessment of Therapy | Scores based on a on a scale from 0 = No response to therapy; 1 = Barely perceptible or minimal response to therapy; 2 = Very slight or low response to therapy; 3 = Slight or low response to therapy; 4 = Slight/low to moderate response to therapy; 5 = Moderate response to therapy; 6 = Moderate to substantial response to therapy; 7 = Substantial response to therapy; 8 = Substantial to significant response to therapy; 9 = Significant response to therapy; 10 = Excellent response to therapy | at discontinuation of therapy within 10 days | 
| Subject's Global Assessment of Therapy | Taking into account speed and quality of the response, subjects provided an overall assessment of the therapy with scores on a scale from 0= no response to 10= excellent response. | at discontinuation of therapy within 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days to Heal | Clinician/Investigator's assessed time to healing. The day the Clinician's assessment of lesion stage was healed was used as the time to heal score. | at day healed within 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cold Sore Patch