Clinical trial NCT06089252: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: HSV Infection
Lead sponsor: Iveriapharma LLC
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Lazolex gel
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Course of the disease
timeFrame: 10 days
measure: Change in outbreak frequency
timeFrame: 10 days
measure: Change in outbreak frequency
timeFrame: 4 years
Secondary outcomes:
measure: The degree of patient satisfaction
timeFrame: 10 days
measure: Number of complaints and symptoms
timeFrame: 10 days
Other outcomes:
Locations:
Study officials:
affiliation: National Center of Dermatology and Venereology, Tblisi (Georgia)
name: Tina A. Kituashvili, Ph.D,
role: PRINCIPAL_INVESTIGATOR
References:
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.