Cold Sores
Conditions
Brief summary
Focus Consumer Healthcare has developed Herpecin L. Herpecin L combines many different ingredients hypothesized to promote quick healing and symptom reduction from cold sores.
Interventions
OTHERHerpecin L
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).
Sponsors
Citruslabs
Focus Consumer Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary aim of this research is to understand the changes in cold sore severity. | 12 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary objective of this trial is to examine differences in cold sore frequency between the two groups. | 12 weeks | 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. |
Countries
United States
Outcome results
None listed