Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LHERP® in patients with recurrent orofacial herpes infections.

Phase 1

• Conditions: Patients presenting recurrent orofacial herpes infections (6 or more episodes within the 12 months period prior to study entry); MedDRA version: 20.1Level: PTClassification code: 10067152Term: Oral herpes Class: 100000004862; MedDRA version: 20.0Level: HLTClassification code: 10019972Term: Herpes viral infections Class: 10021881; MedDRA version: 21.1Level: PTClassification code: 10019948Term: Herpes simplex Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2024-514358-56-00
• Lead Sponsor: abo'Life Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-08
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

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 microimmunotherapy 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 clinical trial of medicinal product
• Study Design: Not specified