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

NCT05796635 | Completed

• 1 other identifier: 20274
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Study Arms (2)

Herpecin L

EXPERIMENTAL

Participants will use Herpecin L Everyday Protection lip balm.

Other: Herpecin L

Controlled Arm

NO INTERVENTION

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

Interventions

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).

Herpecin L

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Focus Consumer Healthcare: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Herpes Labialis

Interventions

Allantoin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals; Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 3, 2023
• Study Start: January 4, 2023
• Primary Completion: January 26, 2023
• Study Completion: February 20, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-04

Locations

US (1)