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Completed

NCT Number: NCT06089252

Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex

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

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Key information

Conditions

HSV Infection DNA Virus Infections Herpes Simplex Herpesviridae Infections Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

walnut extract

Drug

Four times a day over a 10-day period

Other names: Lazolex gel

Primary outcomes

  1. Course of the disease

    Time frame: 10 days

    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.

  2. Change in outbreak frequency

    Time frame: 10 days

    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.

  3. Change in outbreak frequency

    Time frame: 4 years

    Change in outbreaks along time

Secondary outcomes

  1. The degree of patient satisfaction

    Time frame: 10 days

    The level of patient satisfaction with treatment efficacy was categorized as high, medium, or low using a self-questionnaire.

  2. Number of complaints and symptoms

    Time frame: 10 days

    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

Sponsors and collaborators

Lead sponsor

Iveriapharma LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Oct 18, 2023
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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