Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex Mucocutaneous Infections and the Prevention of Recurrences: A Pilot Study

CT-000032

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

2007-11-27

2007-12-28

2008-01-28

Completed

Early phase I

30

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Lazolex gel', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2023-10-18