Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex

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

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

Study Overview

• Status: Completed
• Conditions: HSV Infection
• Intervention / Treatment: Drug: walnut extract

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HSV-1, HSV-2; 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; Four times a day over a 10-day period; Other Names: Lazolex gel

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Iveriapharma LLC
• Investigators: Principal Investigator: Tina A. Kituashvili, Ph.D,, National Center of Dermatology and Venereology, Tblisi (Georgia)

Publications and helpful links

General Publications

• Kituashvili TA, Kvirkvelia VG, Galdava GG, Archvadze NG. Efficacy of Lazolex(R) Gel in the Treatment of Herpes Simplex Mucocutaneous Infections and the Prevention of Recurrences: A Pilot Study. Can J Infect Dis Med Microbiol. 2022 Nov 16;2022:4413679. doi: 10.1155/2022/4413679. eCollection 2022.

Helpful Links

• Can J Infect Dis Med Microbiol

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2007
• Primary Completion (Actual): December 28, 2007
• Study Completion (Actual): January 28, 2008

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Infections; Herpes Simplex
• Other Study ID Numbers: CT-000032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No