Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections.
ConditionHerpes Simplex
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16-80
SponsorLabo'Life
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Man or woman aged 16-80 years,
Patient presenting 6 or more episodes of orofacial herpes infections during the preceding 12-months' period (prior to the study entry),
Woman of childbearing age under effective contraception,
Patient reporting a current stable sexual relationship (steady sexual partner during study duration),
Disqualifiers
Pregnant or breastfeeding woman,
Patient under immunotherapy (including immunosuppressive treatment) or micro-immunotherapy received during last previous 6 months,
Patient who had a suppressive antiviral therapy during last month,
Patient who wishes to continue his/her suppressive antiviral therapy,
Trial design
Design model
Parallel
Treatments tested in this trial
2LHERP®
DrugThe 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.
Placebo
DrugThe 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: 2LHERP® armExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months.
The primary objective of the study will be to evaluate the change from baseline within the number of episodes of herpes infections observed for 12 months, where the baseline value is the number of episodes experienced within the 12 months preceeding study enrolment.
Time frame
12 monthsSecondary outcomes
1
Remaining herpes infection recurrence free 12 months after treatment initiation (yes/no)
The objective of this outcome will be to compare the number of patients recurrence free for 12 months between the treated and the placebo group.
Time frame
12 months2
Remaining herpes infection recurrence free 6 months after treatment initiation (yes/no)
The objective of this outcome will be to compare the number of patients recurrence free for 6 months after treatment initiation between the treated and the placebo group.
Time frame
6 months3
Number of episodes of herpes infection observed at 6 months
The objective of this outcome will be to compare the number of herpetic episodes at 6 months and the baseline number of episodes.
Time frame
6 months4
Time to first recurrence of herpes infection during the treatment
The objective of this outcome will be to compare the time to first herpetic recurrence between the treated and the placebo group.
Time frame
6 months Source ClinicalTrials.gov