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

Sponsor

Focus Consumer Healthcare (Other)

Overall Status

Completed

CT.gov ID

NCT05796635

Collaborator

Citruslabs (Industry)

Enrollment

Location

Arms

1.5

Actual Duration (Months)

51.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cold Sores	Other: Herpecin L	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 4, 2023

Actual Primary Completion Date :

Jan 26, 2023

Actual Study Completion Date :

Feb 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Herpecin L Participants will use Herpecin L Everyday Protection lip balm.	Other: Herpecin 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).
No Intervention: Controlled Arm Participants will not use any cold sore products or lip balms.

Arm

Intervention/Treatment

Experimental: Herpecin L

Participants will use Herpecin L Everyday Protection lip balm.

Other: Herpecin 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).

No Intervention: Controlled Arm

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Citruslabs	Santa Monica	California	United States	90404

Sponsors and Collaborators

Focus Consumer Healthcare
Citruslabs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Focus Consumer Healthcare

ClinicalTrials.gov Identifier:

NCT05796635

Other Study ID Numbers:

20274

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Herpes Labialis

Allantoin

Study Results

No Results Posted as of Apr 3, 2023