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RECRUITING
NCT04065971
PHASE4

Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections.

Sponsor: Labo'Life

View on ClinicalTrials.gov

Summary

Herpes simplex virus (HSV) infection is very common, as most people will experience herpetic infection during their lifetime. The most common manifestation of HSV infection is sores which may appear at any age. No specific antiviral therapy is available to totally cure herpetic infections and today, there is no treatment that allows the definitive eradication of the virus. The 2LHERP® has been available for more than 20 years, and has received a marketing authorization in Belgium by the FAMHP. It is used as an immune regulator in the treatment of herpetic infections. Since 2LHERP® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the disappearance of herpetic recurrences. The purpose of this placebo-controlled trial is to evaluate the efficacy of 2LHERP® on the treatment of herpetic infections in adults.

Official title: Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Orofacial Herpes Infections.

Key Details

Gender

All

Age Range

16 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2020-03-10

Completion Date

2027-03-31

Last Updated

2024-10-31

Healthy Volunteers

No

Conditions

Interventions

DRUG

2LHERP®

The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.

DRUG

Placebo

The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.

Locations (6)

Private Practice

Beerzel, Belgium

Cabinet privé

Beuzet, Belgium

Clinique Saint-Luc (Bouge)

Bouge, Belgium

Private Practice

Linkebeek, Belgium

Cabinet privé

Noirefontaine, Belgium

Private Practice

Oisquercq, Belgium