ORALHERP : Treatment for labial herpes 

Claims

Mode of Action

• Protective Barrier:  Forms a protective film on the affected area, shielding it from external contaminants and reducing further irritation. This creates a favorable environment for improved comfort while keeping the lesion hydrated, thanks to the presence of glycerol.
• Mechanical Cleaning: Utilizes osmotic action to keep the affected area clean by drawing out excess fluid and removing contaminants, helping to reduce inflammation, swelling, and symptoms.
• Cellular Repair: Promotes and accelerates healing and regeneration of the affected area, providing sustained relief while maintaining a favorable environment for improved comfort and supporting the skin's natural healing process.

Clinical study

An open-label, single-arm, multicenter clinical trial demonstrated the effectiveness of ORALHERP in alleviating symptoms associated with labial herpes, including pain, burning, itching, and tingling, as well as reducing blister oozing. Additionally, ORALHERP was shown to limit viral spread while promoting and accelerating the healing process.

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• TYPE OF TRIAL: An open-label, single-arm, multicenter | 14 days
• PATIENTS: N=60 patients
• INCLUSION: Participant having all clinical sign and symptoms of labial herpes infection and presented within 24 hrs of onset 

Key Findings

Reduction in Viral Particles:

1. • A significant reduction (38%) in viral particles was observed 2 hours after the first application.
   • The decrease progressed to 52.1% by day 4, 69.9% by day 7, and reached 100% elimination by day 14.

Lesion Healing:

1. • Lesion size showed no immediate change after the first application.
   • By day 4, the lesion size reduced by 55.3%, decreasing further to 87.4% by day 7, with complete healing observed by day 14.

Symptom Relief (Tingling, Itching, Burning, Prickling):

1. • Moderate to severe symptoms were present in 80% of patients at baseline.
   • Mild improvements were noted 2 hours after the first application, but significant relief began by day 4.
   • By day 7, symptoms were minimal, and by day 14, there were no symptoms in any patients.

Pain Relief:

1. • Pain intensity reduced significantly within 2 hours of application in some patients.
   • By day 4, pain was significantly reduced in most patients, and by day 14, all patients were pain-free.

Blister Oozing:

1. • Oozing increased slightly within the first 2 hours due to the osmotic action of the product.
   • Significant reduction in oozing was observed by day 4, with complete resolution by day 14.

Tenderness, Soreness, and Swelling:

1. • Moderate to mild tenderness, soreness, and swelling diminished significantly starting day 4.
   • By day 7, these symptoms were minimal, and by day 14, they were completely resolved.

Adjacent Blisters:

1. • At baseline, most patients had small adjacent blisters.
   • Healing of open blisters progressed rapidly with the product, with complete resolution of all adjacent blisters by day 14.
   • The product was less effective on unopened blisters.

Safety:

• No undesirable topical effects were reported by the patients, indicating that the product is safe for topical application on labial herpes lesions.
• ORALHER¨P was rated as "very well tolerated" by 93% of investigators and 91.67% of patients.
• Standard blood biochemical and urine parameters showed no significant changes before and after the treatment, further confirming the safety of the product.

Conclusion:

ORALHERP demonstrates rapid and significant reductions in viral load and lesion size, beginning within 2 hours of the first application. Symptom relief and lesion healing begin by the 2 hours of the first application and became significant by day 4, with complete resolution achieved by day 14. Its excellent tolerability and safety profile make HL-VB a highly effective and patient-friendly option for managing labial herpes lesions.