Deoxyribonucleic acid; Ribonucleic acid; Specific nucleic acid SNA-HER1; Specific nucleic acid SNA-HER2; Specific nucleic acid SNA-HLA I; Specific nucleic acid SNA-HLA II for Recurrent orofacial herpes | Oral herpes | Herpes simplex

Inclusion criteria

• {"criterion_text":"- Man or woman aged 16-80 years\n- Patient presenting 6 or more episodes of orofacial herpes infections during the preceding 12-months’ period (prior to the study entry)\n- Woman of childbearing age under effective contraception\n- Patient reporting a current stable sexual relationship (steady sexual partner during study duration)\n- Patient having faculties to understand and respect the constraints of the study\n- Signature of the Informed Consent Form."}

Exclusion criteria

• {"criterion_text":"- Pregnant or breastfeeding woman\n- Patient under immunotherapy (including immunosuppressive treatment) or microimmunotherapy received during last previous 6 months\n- Patient who had a suppressive antiviral therapy during last month\n- Patient who wishes to continue his/her suppressive antiviral therapy\n- Patient with known lactose intolerance, galactose intolerance, lactase Lapp deficiency or glucose-galactose malabsorption syndrome\n- Patient who participated in a clinical study in the previous 3-month period\n- 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\n- Patient with severe immunodeficiency disease requiring long term treatment (*) or under chemotherapy or radiotherapy or corticoid therapy\n- Patient under listed homeopathic or phytotherapy treatment\n- Patient using or addicted to recreational drugs\n\n(*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Change from baseline in number of herpes infection episodes observed over 12 months; baseline defined as the number of episodes in the 12 months prior to study enrolment."}

Secondary endpoints

• {"endpoint_text":"- a.1) Remaining herpes infection recurrence free 12 months after treatment initiation\n- a.2) Remaining herpes infection recurrence free 6 months after treatment initiation\n- a.3) Number of episodes of herpes infection observed at 6 months\n- b) Time to first recurrence of herpes infection during the treatment\n- c) Mean duration of episodes\n- d) Level of pain during episodes\n- e) Use of Rescue Medication\n- f) Quality of Life\n- e) Occurrence of AEs and SAEs","definition_or_measurement_approach":"As listed: recurrence-free status at 6 and 12 months, episode counts at 6 months, time-to-first recurrence, mean episode duration, pain level during episodes, use of rescue medication, quality of life measures, and safety outcomes (AEs/SAEs). Specific measurement instruments/timing not specified in summary JSON."}

Methods

• Use of recruitment materials (posters and advertisements) as evidenced by documents: K2_Recruitment material_Poster_EN/FR/NL and K2_Recruitment material_advertisement_EN.
• Site-based recruitment through participating healthcare sites (general practitioner and dermatology/gynecology private practices and a clinic) in Belgium (listed trial sites).
• Recruitment arrangements documented in K1_Recruitment arrangements_EN_Public and K1_Recruitment and consent procedure documents.

Belgium

Earliest CTIS Part Ii Submission Date

06-05-2024

Latest Decision Or Authorization Date

09-02-2026

Processing Time Days

644

Number Of Sites

7

Number Of Participants

140

Primary sponsor

Full Name

Labo'Life Belgium

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium