Back to resultsEfficacy of Lazolex® Gel in the Treatment of Herpes Simplex
Primary Purpose
HSV Infection
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
walnut extract
Sponsored by
About this trial
This is an interventional treatment trial for HSV Infection
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
HSV-1, HSV-2
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Change in outbreak frequency
Change in outbreaks along time
Secondary Outcome Measures
The degree of patient satisfaction
The level of patient satisfaction with treatment efficacy was categorized as high, medium, or low using a self-questionnaire.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06089252
Brief Title
Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex
Official Title
Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex Mucocutaneous Infections and the Prevention of Recurrences: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 27, 2007 (Actual)
Primary Completion Date
December 28, 2007 (Actual)
Study Completion Date
January 28, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iveriapharma LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HSV Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Lazolex gel
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HSV-1, HSV-2
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
walnut extract
Other Intervention Name(s)
Lazolex gel
Intervention Description
Four times a day over a 10-day period
Primary Outcome Measure Information:
Title
Course of the disease
Description
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.
Time Frame
10 days
Title
Change in outbreak frequency
Description
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.
Time Frame
10 days
Title
Change in outbreak frequency
Description
Change in outbreaks along time
Time Frame
4 years
Secondary Outcome Measure Information:
Title
The degree of patient satisfaction
Description
The level of patient satisfaction with treatment efficacy was categorized as high, medium, or low using a self-questionnaire.
Time Frame
10 days
Title
Number of complaints and symptoms
Description
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
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina A. Kituashvili, Ph.D,
Organizational Affiliation
National Center of Dermatology and Venereology, Tblisi (Georgia)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36437891
Citation
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/
Description
Can J Infect Dis Med Microbiol
Learn more about this trial
Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex
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