Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex | NCT06089252

NCT06089252

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HSV-1, HSV-2	Other	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

Name	Type	Description	Arm Group Labels	Other Names
walnut extract	Drug	Four times a day over a 10-day period	HSV-1, HSV-2

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Tina A. Kituashvili, Ph.D,	National Center of Dermatology and Venereology, Tblisi (Georgia)	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36437891	Result	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.

Label	URL
Can J Infect Dis Med Microbiol	View source

IPD Sharing Statement Module

Condition Browse Module

ID	Term
D006561	Herpes Simplex

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

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