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

NCT ID: NCT05796635

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-04
• Study Completion Date: 2023-02-20

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.

Conditions

Cold Sores

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Herpecin L

Participants will use Herpecin L Everyday Protection lip balm.

Group Type: EXPERIMENTAL

Herpecin L

Intervention Type: 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).

Controlled Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Focus Consumer Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

20274

Identifier Type: -

Identifier Source: org_study_id