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OpenTrials
Completed

NCT Number: NCT05796635

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

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

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Herpecin L

Other

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).

Primary outcomes

  1. The primary aim of this research is to understand the changes in cold sore severity.

    Time frame: 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 outcomes

  1. The secondary objective of this trial is to examine differences in cold sore frequency between the two groups.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Focus Consumer Healthcare

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2023
Registry last updated
Apr 3, 2023

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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