Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex

• Sponsor: Iveriapharma LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06089252
• Collaborator: (none)
• Enrollment: 30
• Arm: 1
• Actual Duration (Months): 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
HSV Infection	Drug: walnut extract	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Lazolex gelLazolex gel
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex Mucocutaneous Infections and the Prevention of Recurrences: A Pilot Study
• Actual Study Start Date: Nov 27, 2007
• Actual Primary Completion Date: Dec 28, 2007
• Actual Study Completion Date: Jan 28, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Course of the disease [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 [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 [4 years]

   Change in outbreaks along time

Secondary Outcome Measures

1. The degree of patient satisfaction [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Iveriapharma LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Can J Infect Dis Med Microbiol

Publications

None provided.

• Responsible Party: Iveriapharma LLC
• ClinicalTrials.gov Identifier: NCT06089252
• Other Study ID Numbers: CT-000032
• First Posted: Oct 18, 2023
• Last Update Posted: Oct 18, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Herpes Simplex

Study Results

No Results Posted as of Oct 18, 2023