An Investigation Into the Efficacy of Herpecin L at Reducing the Frequency and Severity of Cold Sores

Study Overview
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Brief Summary
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Focus Consumer Healthcare has developed Herpecin L. Herpecin L combines many different ingredients hypothesized to promote quick healing and symptom reduction from cold sores.

Official Title
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An Investigation Into the Efficacy of Herpecin L at Reducing the Frequency and Severity of Cold Sores

Conditions
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Cold Sores

Intervention / Treatment
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* Other: Herpecin L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Female between 18-60 years of age. Must be in good health with no significant chronic conditions and a BMI under 35. Must experience regular cold sores or fever blisters Must agree to avoid daily lip balm or another product designed to alleviate their cold sore (e.g., Abreva or other over-the-counter cold sore products). Exclusion Criteria: Suffers from pre-existing conditions that would prevent them from adhering to the protocol including chronic conditions such as oncological or psychiatric disorders. Anyone with known severe allergic reactions. Unwilling to follow the study protocol. Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Herpecin L<br>Participants will use Herpecin L Everyday Protection lip balm. | Other: Herpecin L<br>* Participants in the Herpecin L arm will use the test product daily as a preventive product by applying the product twice daily. Also, participants will be told they can reapply the product if going outside into the cold, wind, or sun. If participants in the Herpecin L arm do experience a cold sore or fever blister, they will be instructed to use the product at the first sign of the cold sore and then at least four more times during the day until the cold sore is gone (they can use the product more often if they plan to go outside into the cold, sun, or wind).<br>|
| No Intervention: Controlled Arm<br>Participants will not use any cold sore products or lip balms. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary aim of this research is to understand the changes in cold sore severity. | Cold sore severity will be measured via survey and cold sore severity grading. Symptom severity is rated on a scale of 0 (Not a problem) to 6 (Severe) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective of this trial is to examine differences in cold sore frequency between the two groups. | Cold sore frequency will be measured via a self-reported survey measuring the frequency of cold sore occurrence during the study period compared to baseline. | 12 weeks |