Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex

Iveriapharma

Status and phase: Completed; Phase 2

Conditions: HSV Infection

Treatments: Drug: walnut extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT06089252

CT-000032

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

HSV-1, HSV-2

Other group

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.

Treatment:

Drug: walnut extract