Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections.

Launched by LABO'LIFE · Aug 21, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called 2LHERP® for people with orofacial herpes infections, which are common sores caused by the herpes simplex virus. The goal is to see how effective 2LHERP® is in helping adults who have had multiple outbreaks of these sores. The trial is currently recruiting participants aged between 16 and 80 who have experienced six or more episodes of orofacial herpes in the past year. It’s important that women of childbearing age are using effective contraception and that participants have a stable sexual relationship during the study.

If you decide to join the trial, you will receive either the 2LHERP® treatment or a placebo (a substance with no active medication) for comparison. Participants will be asked to follow the study for 12 months, and your involvement will help researchers understand whether 2LHERP® can improve the management of herpes infections. Please note, there are certain criteria that might exclude you from participating, such as being pregnant or breastfeeding, undergoing specific treatments, or having certain health conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.