Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex

Study Overview
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Brief Summary
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Study aimed to evaluate the efficacy and tolerance of Lazolex®, an emollient gel, to treat mucocutaneous lesions caused by herpes simplex virus.

Detailed Description
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A single-center, single-arm, open-label, phase II clinical trial was conducted with 30 patients divided into two groups: 15 patients with herpes simplex virus type 1 (HSV-1) infections and 15 with herpes simplex virus type 2 (HSV-2) infections. All received topical treatment with Lazolex® Gel four times daily for 10 days. The efficacy and tolerance of the treatment were evaluated on day 10 and day 20 after the study started. In addition, recurrence rates were evaluated before treatment with Lazolex® and after a 4-year follow-up period after treatment.

Official Title
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Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex Mucocutaneous Infections and the Prevention of Recurrences: A Pilot Study

Conditions
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HSV Infection

Intervention / Treatment
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* Drug: walnut extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of acute or chronic herpes simplex mucocutaneous infection, mild course of disease (defined as body temperature <37.2°C and without signs of general infirmity), application of last treatment for herpes simplex infection >3 months, available to cooperate during the study, provision of written informed consent. Exclusion Criteria: abnormal laboratory results, hypersensitivity to the product or its components, pregnancy or breastfeeding, acute/ chronic renal or liver failure, history of migraine, organic brain lesion, generalized anxiety disorder, blood supply disturbance in the vertebrobasilar pool, stage 3 essential hypertension, concomitant acute or decompensated disease that could affect the study results, intake of acyclovir, antibiotics, immunosuppressants, antimetabolites, or glucocorticosteroids during 3-month period prior to the study, concomitant participation in another clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Lazolex gel
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HSV-1, HSV-2<br>All participants were assigned to receive topical treatment with Lazolex® Gel. Patients were given the gel at the end of the screening visit (day 0) by the attending physicians.,e gel was applied to the lesion four times a day over a 10-day period, with the Lrst application at 9 am and the fourth at 9 pm. Patients administered Lazolex® Gel to the a2ected areas themselves. | Drug: walnut extract<br>* Four times a day over a 10-day period<br>* Other names: Lazolex gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of the disease | Lazolex® Gel was classified as effective if herpes lesions improved or healed after treatment. The median effective time (ET50), defined as the time (in days) needed to reach complete recovery in 50% of the patients, was used as the main variable for Lazolex® Gel efficacy. | 10 days | 
| Change in outbreak frequency | Lazolex® Gel was classified as effective if herpes lesions improved or healed after treatment. The median effective time (ET50), defined as the time (in days) needed to reach complete recovery in 50% of the patients, was used as the main variable for Lazolex® Gel efficacy. | 10 days | 
| Change in outbreak frequency | Change in outbreaks along time | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of patient satisfaction | The level of patient satisfaction with treatment efficacy was categorized as high, medium, or low using a self-questionnaire. | 10 days | 
| Number of complaints and symptoms | Tolerance outcomes were evaluated using both objective and subjective criteria. The objective criteria included the comparison of laboratory tests and physical examinations before and after Lazolex® Gel treatment. The subjective criteria included complaints and symptoms reported by patients. In the event of adverse reactions, they were assessed by attending physicians. Individual tolerance was categorized as follows: Very satisfactory: No clinically significant changes in physical examination or laboratory tests, and no adverse reactions. Satisfactory: Insignificant changes in physical examination or laboratory tests, or mild adverse reactions that do not require a change in treatment. Unsatisfactory: Significant changes in physical examination or laboratory tests and/or the occurrence of adverse reactions that require the withdrawal of the product, as well as prescribing treatment to address the adverse reaction | 10 days |