A Placebo-Controlled, Randomized, Double-Blinded Study in a Parallel-Group Comparison to evaluate Efficacy and Safety of a Lysine Containing Dietary Food for Special Medicinal Purposes vs. Placebo for the Treatment of Herpes Labialis

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 205

Inclusion Criteria

Inclusion Criteria for the Run-in Phase
Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the run-in phase of the trial:
•Patients with at least 2 but not more than 4 episodes of recurrent herpes labialis in the last 12 months before the start of trial.
•Age of the patient between 18 and 65 years
•Written informed consent.

Inclusion Criteria for the Treatment Phase
Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the treatment phase of the trial:
•All inclusion criteria of the run-in phase have to be answered with a YES.
•Exclusion criteria 2 - 9 of the run-in phase have to be answered with a NO
•Patients with an acute herpes labialis for not more than 48 hours.
•Treatment of the acute herpes labialis was initiated not later than 6 hours after the first signs of prodrome.
•Last episode resolved at least 14 days before start of treatment
•Affected site is restricted to the nasal and labial area
•One single site of herpes

Exclusion Criteria

Exclusion Criteria for the Run-in Phase
Subjects presenting any of the following exclusion criteria must not be included in the run-in phase of the trial:
•Patients with an existing herpes labialis currently under treatment.
•Patients with an existing herpes labialis not yet under treatment, but whose prodrome began more than 6 hours ago.
•Intake of medication or supplements containing more than 1 g of L-Lysine per day during the last 14 days.
•Medical or dermatological conditions that interfere with the treatment or assessment of the herpes lesions (e.g., eczema, psoriasis, acne, seborrhoeic dermatitis).
•Immunosuppressive disease.
•Systemic, severe as well as history of uncontrolled chronic disease or a concurrent clinically significant illness, or medical condition, which in the investigator’s opinion, would contraindicate study participation or compliance with protocol mandated procedures.
•Alcohol or drug abuse.
•Hypersensitivity to L-lysine and / or to the ingredients of the investigational nutritional supplement.
•Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product or nutritional product within 30 days prior to written informed consent for this trial.

Exclusion Criteria for the Treatment Phase
Subjects presenting any of the following exclusion criteria must not be included in the treatment phase of the trial:
•Patients with multiple sites of beginning herpes.
•Topical and / or systemic treatments for herpes (including antiviral agents, anti-inflammatory agents, analgesic agents, immunomodulating drugs) during 14 days before treatment of herpes.
•Intake of medication or supplements containing more than 1 g of L-Lysine per day during 14 days before treatment of herpes.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is defined as the duration of fluid-filled vesicles plus the duration of the wet ulcer, e.g. the time between start of fluid-filled vesicles until the end of wet ulcers.

Secondary Outcome Measures

Name	Time	Method
•Extent and grading of total herpes symptoms per day.<br>•Extent and grading of impairment of quality of life by herpes labialis per day.<br>•Presence, size and duration of various herpes stages in total and per day.<br>•Time to appearance of liquid-filled vesicles<br>•Time to loss of crust and new skin<br>•Appearance of new herpes lesions<br>•Administration of rescue medication<br>•Subjective evaluation of efficacy by patient<br>•Question regarding future use of INP<br>•Subjective evaluation of tolerability by patient<br>•Adverse events<br>