Patients presenting recurrent orofacial herpes infections (6 or more episodes within the 12 months period prior to study entry)
Conditions
Brief summary
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.
Detailed description
a.1) Remaining herpes infection recurrence free 12 months after treatment initiation, a.2) Remaining herpes infection recurrence free 6 months after treatment initiation, a.3) Number of episodes of herpes infection observed at 6 months, b) Time to first recurrence of herpes infection during the treatment, c) Mean duration of episodes, d) Level of pain during episodes, e) Use of Rescue Medication, f) Quality of Life, e) Occurrence of AEs and SAEs
Interventions
DRUG2LHERP granules en gélules à ouvrir
DRUGPlacebo
Sponsors
Labo'Life Belgium
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| a.1) Remaining herpes infection recurrence free 12 months after treatment initiation, a.2) Remaining herpes infection recurrence free 6 months after treatment initiation, a.3) Number of episodes of herpes infection observed at 6 months, b) Time to first recurrence of herpes infection during the treatment, c) Mean duration of episodes, d) Level of pain during episodes, e) Use of Rescue Medication, f) Quality of Life, e) Occurrence of AEs and SAEs | — |
Countries
Belgium
Outcome results
None listed