Patients presenting recurrent orofacial herpes infections (6 or more episodes within the 12-months’ period prior to their study entry). MedDRA version: 20.0 Level: HLT Classification code 10019972 Term: Herpes viral infections System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1 Level: PT Classification code 10067152 Term: Oral herpes System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: PT Classification code 10019948 Term: Herpes s
Conditions
Interventions
Trade Name: 2LHERP®
Product Name: 2LHERP®
Pharmaceutical Form: Pillules
Pharmaceutical form of the placebo: Pillules
Route of administration of the placebo: Oromucosal use
Sponsors
LABO’LIFE Belgium sprl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Man or woman aged 18-80 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding woman, - Patient under immunotherapy (including immunosuppressive treatment) or micro-immunotherapy received during last previous 6 months, - Patient who has 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 on 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes infections at 12 months.;Secondary Objective: Secondary objectives: comparison of the efficacy of 2LHERP® vs placebo according to the following aspects: a) number of episodes at 6 months and 12 months, b) time to first episode during the treatment, c) duration of episodes, d) symptomatology during the entire relapse time, e) use of Rescue Medication (RM), f) evaluation of impact on the quality of life, g) safety issues. ;Primary end point(s): Reduction (yes/no) in the number of recurrences of orofacial herpes infection within the 12 months following treatment initiation. ;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a.1) Remaining herpes infection recurrence free 12 months after treatment initiation (yes/no), a.2) Remaining herpes infection recurrence free 6 months after treatment initiation (yes/no), a.3) 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, a.4) Number of episodes of herpes infection observed at 6 months and at 12 months, b) Time to first recurrence of herpes infection during the treatment, c) 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, d) Level of pain recorded daily on a visual analogue scale (100mm), as well as other associated symptomatology for orofacial pain (orofacial fissures, difficulties to eat/drink, orofacial pain, fever, QoL), which will be consequently measured as area under the curve (AUC), e) 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, f) Quality of life evaluated via a 6-items questionnaire, g) Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug. ;Timepoint(s) of evaluation of this end point: a.1) 12 months, a.2) 6 months , a.3) 12 months, a.4) 6 months and 12 months, b) until 12 months, c) until 12 months, d) until 12 months, e) until 12 months, f) 6 months and 12 months, g) until 6 months. | — |
Countries
Belgium
Contacts
Public ContactClin Research Coord, Astrid Garreau
Labo’Life France
Outcome results
None listed