Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections.
- Conditions
- Herpes Simplex
- Interventions
- Drug: 2LHERP®Drug: Placebo
- Registration Number
- NCT04065971
- Lead Sponsor
- Labo'Life
- Brief 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.
- Detailed Description
The study duration will be 36 months with 24 months of inclusion (that may be extended if the expected number of patients is not reached after this period) and 12 months of follow-up.
Patients aged between 16 and 80 years who present recurrent orofacial herpes infections (6 or more episodes within the 12-months' period prior to their study entry).
The total number of patients to include will be 140 with 70 patients per group.
Primary objective:
Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months.
Secondary objectives:
Comparison of the efficacy of 2LHERP® vs placebo according to the following aspects:
1. number of episodes at 6 months,
2. time to first episode during the treatment,
3. duration of episodes,
4. symptomatology during the entire relapse time,
5. use of Rescue Medication (RM),
6. evaluation of impact on the quality of life,
7. safety issues.
Treatment phase:
* Group n°1 = 2LHERP® (6 months of treatment)
* Group n°2 = Placebo (6 months of treatment) Post-treatment follow-up phase: 6 months. Treatment will be considered successful if the number of herpetic episodes is reduced.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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),
- Patient having faculties to understand and respect the constraints of the study,
- Signature of the Informed Consent Form.
- 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,
- Patient with known lactose intolerance,
- Patient who participated in a clinical study in the previous 3-month period,
- Patient who is not sufficiently motivated to engage in a follow-up period of 12 months, or likely to travel or to move before the end of the study,
- Patient with severe immunodeficiency disease requiring long term treatment (*) or under chemotherapy or radiotherapy or corticoid therapy,
- Patient under listed homeopathic or phytotherapy treatment,
- Patient using or addicted to recreational drugs.
(*) important renal or respiratory insufficiency, transplanted or grafted patients HIV/AIDS, terminal cancer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2LHERP® arm 2LHERP® Group N°1: 2LHERP® treatment (6 months of treatment) Placebo arm Placebo Group N°1: Placebo treatment (6 months of treatment)
- Primary Outcome Measures
Name Time Method Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months. 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.
- Secondary Outcome Measures
Name Time Method Remaining herpes infection recurrence free 12 months after treatment initiation (yes/no) 12 months 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.
Remaining herpes infection recurrence free 6 months after treatment initiation (yes/no) 6 months 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.
Number of episodes of herpes infection observed at 6 months 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 to first recurrence of herpes infection during the treatment 6 months The objective of this outcome will be to compare the time to first herpetic recurrence between the treated and the placebo group.
Mean duration of episodes, the duration for a given episode being defined as the number of days between the start of the episode and the last day before all symptoms recorded as 'none' for 2 consecutive days, in the patient diary 12 months The objective of this outcome will be to compare the mean duration of the herpetic episodes between the treated and the placebo group.
Level of pain recorded daily as well as other associated symptomatology for orofacial pain, which will be consequently measured as area under the curve 12 months The objective of this outcome will be to compare the level of pain during herpetic episodes between the treated and the placebo group.
Use of daily rescue medicine (RM), expressed with the cumulative number of days for the treatment period, the follow-up period and the entire study period 12 months The objective of this outcome will be to compare the use of rescue medication during herpetic episodes between the treated and the placebo group.
Quality of life evaluated via a 6-items questionnaire 6 and 12 months The objective of this outcome will be to compare the quality of life between the treated and the placebo group.
Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug 6 months The objective of this outcome is to evaluate the safety of the treatment
Trial Locations
- Locations (3)
Private Practice
🇧🇪Oisquercq, Belgium
Cabinet privé
🇧🇪Noirefontaine, Belgium
Clinique Saint-Luc (Bouge)
🇧🇪Bouge, Belgium