NCT06089252

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2008

Completed
15.7 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
Last Updated

October 18, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

September 27, 2023

Last Update Submit

October 16, 2023

Conditions

HSV Infection

Outcome Measures

Primary Outcomes (3)

  • 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 (2)

  • The degree of patient satisfaction

    10 days

  • Number of complaints and symptoms

    10 days

Study Arms (1)

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

Interventions

walnut extractDRUG

Four times a day over a 10-day period

Also known as: Lazolex gel
HSV-1, HSV-2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36437891RESULT

Related Links

MeSH Terms

Conditions

Herpes Simplex

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Tina A. Kituashvili, Ph.D,

    National Center of Dermatology and Venereology, Tblisi (Georgia)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Lazolex gel
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 18, 2023

Study Start

November 27, 2007

Primary Completion

December 28, 2007

Study Completion

January 28, 2008

Last Updated

October 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share