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

Primary Purpose

Cold Sores

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Herpecin L

About this trial

This is an interventional prevention trial for Cold Sores

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Citruslabs

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Herpecin L

Controlled Arm

Arm Description

Participants will use Herpecin L Everyday Protection lip balm.

Participants will not use any cold sore products or lip balms.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05796635

First Posted

March 9, 2023

Last Updated

April 1, 2023

Sponsor

Focus Consumer Healthcare

Collaborators

Citruslabs

1. Study Identification

Unique Protocol Identification Number

NCT05796635

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

January 4, 2023 (Actual)

Primary Completion Date

January 26, 2023 (Actual)

Study Completion Date

February 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Focus Consumer Healthcare

Collaborators

Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cold Sores

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Herpecin L

Arm Type

Experimental

Arm Description

Participants will use Herpecin L Everyday Protection lip balm.

Arm Title

Controlled Arm

Arm Type

No Intervention

Arm Description

Participants will not use any cold sore products or lip balms.

Intervention Type

Other

Intervention Name(s)

Herpecin L

Intervention Description

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 Outcome Measure Information:

Title

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

Description

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)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Citruslabs

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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