Status:
RECRUITING
Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections.
Lead Sponsor:
Labo'Life
Conditions:
Herpes Simplex
Eligibility:
All Genders
16-80 years
Phase:
PHASE4
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 a...
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 b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04065971
Start Date
March 10 2020
End Date
March 31 2027
Last Update
October 31 2024
Active Locations (6)
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1
Private Practice
Beerzel, Belgium, 1650
2
Cabinet privé
Beuzet, Belgium, 5030
3
Clinique Saint-Luc (Bouge)
Bouge, Belgium, 5004
4
Private Practice
Linkebeek, Belgium, 1630