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

Phase 4

Not yet recruiting

Conditions: Patients presenting recurrent orofacial herpes infections (6 or more episodes within the 12 months period prior to study entry)

Brief Summary: Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
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.		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 Outcome Measures

Name	Time	Method
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		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

Locations (12): Private Practice of Dr Laurence Tourné
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Oisquercq, Belgium
Private Practice of Dr Wolfram Fink
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Wavre, Belgium
VIVALIA - Centre Hospitalier de l'Ardenne
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Libramont-Chevigny, Belgium
Private Practice of Dr Myriam Petteau
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Nivelles, Belgium
Private Practice of Dr Pauline Janssens
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Libramont, Belgium
Private Practice of Dr Bernadette Blouard
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Namur, Belgium
Private Practice of Dr Denis Rouleff
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Noirefontaine, Belgium
Clinique Saint-Luc Bouge
🇧🇪
Bouge, Belgium
Private Practice of Dr Isabelle Jeanjot
🇧🇪
Linkebeek, Belgium
Private Practice of Dr Carola Viehe
🇧🇪
Beersel, Belgium
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Private Practice of Dr Laurence Tourné
🇧🇪Oisquercq, Belgium
Laurence Tourné
Site contact
+3223559782
tourne_laurence@msn.com