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

• ClinicalTrials.gov Identifier: NCT04065971
• Recruitment Status: Recruiting
• First Posted: August 22, 2019
• Last Update Posted: January 5, 2023
• Sponsor: Labo'Life
• Information provided by (Responsible Party): Labo'Life

Study Description

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 at any age.

No specific antiviral therapy is available to totally cure herpetic infections and today, there is no treatment that allows the definitive eradication of the virus.

The 2LHERP® has been available for more than 20 years, and has received a marketing authorization in Belgium by the FAMHP. It is used as an immune regulator in the treatment of herpetic infections. Since 2LHERP® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the disappearance of herpetic recurrences.

The purpose of this placebo-controlled trial is to evaluate the efficacy of 2LHERP® on the treatment of herpetic infections in adults.

Condition or disease	Intervention/treatment	Phase
Herpes Simplex	Drug: 2LHERP®; Drug: Placebo	Phase 4

Detailed Description:

The study duration will be maximum 24 months with 12 months of inclusion and 12 months of follow-up.

Patients aged between 16 and 80 years who present recurrent orofacial herpes infections (6 or more episodes within the 12-months' period prior to their study entry).

The total number of patients to include will be 140 with 70 patients per group.

Primary objective:

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

Secondary objectives:

Comparison of the efficacy of 2LHERP® vs placebo according to the following aspects:

1. number of episodes at 6 months,
2. time to first episode during the treatment,
3. duration of episodes,
4. symptomatology during the entire relapse time,
5. use of Rescue Medication (RM),
6. evaluation of impact on the quality of life,
7. safety issues.

Treatment phase:

• Group n°1 = 2LHERP® (6 months of treatment)
• Group n°2 = Placebo (6 months of treatment) Post-treatment follow-up phase: 6 months. Treatment will be considered successful if the number of herpetic episodes is reduced.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Orofacial Herpes Infections.
• Actual Study Start Date: March 10, 2020
• Estimated Primary Completion Date: June 30, 2024
• Estimated Study Completion Date: June 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 2LHERP® arm; Group N°1: 2LHERP® treatment (6 months of treatment)	Drug: 2LHERP®; The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.; Other Name: 2LHERP
Placebo Comparator: Placebo arm; Group N°1: Placebo treatment (6 months of treatment)	Drug: Placebo; The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.

Outcome Measures

Primary Outcome Measures :

1. Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months. [ Time Frame: 12 months ]
   The primary objective of the study will be to evaluate the 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 :

1. Remaining herpes infection recurrence free 12 months after treatment initiation (yes/no) [ Time Frame: 12 months ]
2. Remaining herpes infection recurrence free 6 months after treatment initiation (yes/no) [ Time Frame: 6 months ]
3. Number of episodes of herpes infection observed at 6 months [ Time Frame: 6 months ]
4. Time to first recurrence of herpes infection during the treatment [ Time Frame: 6 months ]
5. Mean duration of episodes, the duration for a given episode being defined as the number of days between the start of the episode and the last day before all symptoms recorded as 'none' for 2 consecutive days, in the patient diary [ Time Frame: 12 months ]
6. Level of pain recorded daily on a visual analogue scale, as well as other associated symptomatology for orofacial pain, which will be consequently measured as area under the curve [ Time Frame: 12 months ]
7. Use of daily rescue medicine (RM), expressed with the cumulative number of days for the treatment period, the follow-up period and the entire study period [ Time Frame: 12 months ]
8. Quality of life evaluated via a 6-items questionnaire [ Time Frame: 6 and 12 months ]
9. Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Danielle GERARD; 473 40 14 58 ext +32; danielle.gerard@labolife.com

Locations

Belgium

Private Practice; Recruiting

Beerzel, Belgium, 1650

Contact: Carola VIEHE, Dr

Principal Investigator: Carola VIEHE, Dr

Cabinet privé; Recruiting

Beuzet, Belgium, 5030

Contact: Denise Peeters, Dr

Principal Investigator: Denise Peeters, Dr

Clinique Saint-Luc (Bouge); Recruiting

Bouge, Belgium, 5004

Contact: Audrey SCHILS, Dr

Principal Investigator: Audrey SCHILS, Dr

Private Practice; Withdrawn

Brussel, Belgium, 1020

Private Practice; Withdrawn

Etterbeek, Belgium, 1040

Private practice; Withdrawn

Gozée, Belgium, 6534

Cabinet privé; Recruiting

Hamme-Mille, Belgium, 1320

Contact: Susanne Hausdorfer, Dr

Principal Investigator: Susanne Hausdorfer, Dr

Private Practice; Withdrawn

Kraainem, Belgium, 1950

Private practice; Recruiting

Libramont, Belgium, 6800

Contact: Pauline Janssens, Dr

Principal Investigator: Pauline Janssens, Dr

Vivalia - Centre Hospitalier de L'Ardenne - Libramont Chevigny; Recruiting

Libramont, Belgium, 6800

Contact: Audrey SCHILS, Dr

Principal Investigator: Audrey SCHILS, Dr

Private Practice; Recruiting

Linkebeek, Belgium, 1630

Contact: Isabelle JEANJOT, Dr

Principal Investigator: Isabelle JEANJOT, Dr

Private Practice; Recruiting

Namur, Belgium, 5000

Contact: Bernadette BLOUARD, Dr

Principal Investigator: Bernadette BLOUARD, Dr

Private practice; Terminated

Nivelles, Belgium, 1400

Cabinet privé; Recruiting

Noirefontaine, Belgium, 6831

Contact: Denis ROULEFF, Dr

Principal Investigator: Denis Rouleff, Dr

Private Practice; Recruiting

Oisquercq, Belgium, 1480

Contact: Laurence TOURNE, Dr

Principal Investigator: Laurence TOURNE, Dr

Private Practice; Terminated

Wavre, Belgium, 1300

Sponsors and Collaborators

Labo'Life

More Information

• Responsible Party: Labo'Life
• ClinicalTrials.gov Identifier: NCT04065971
• Other Study ID Numbers: LLB-2018-01
• First Posted: August 22, 2019
• Last Update Posted: January 5, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Herpes Simplex; Herpesviridae Infections; Infections; DNA Virus Infections; Virus Diseases; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases