Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex

HSV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06089252
• Other study ID #: CT-000032
• Status: Completed
• Phase: Phase 2
• Start date: November 27, 2007
• Est. completion date: January 28, 2008

Study information

• Verified date: September 2023
• Source: Iveriapharma LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 28, 2008
• Est. primary completion date: December 28, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Simplex
• HSV Infection
• Infections

Intervention

Drug:
• walnut extract
Four times a day over a 10-day period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iveriapharma LLC

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in outbreak frequency	Change in outbreaks along time	4 years
Secondary	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
Secondary	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

External Links

•   Can J Infect Dis Med Microbiol