Status:
COMPLETED
Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex
Lead Sponsor:
Iveriapharma LLC
Conditions:
HSV Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 her...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 27 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06089252
Start Date
November 27 2007
End Date
January 28 2008
Last Update
October 18 2023
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