HSV InfectionPhase 2NCT06089252
Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex
A Phase 2 study testing walnut extract in people with HSV Infection, run by Iveriapharma LLC.
Trial summary
Study aimed to evaluate the efficacy and tolerance of Lazolex®, an emollient gel, to treat mucocutaneous lesions caused by herpes simplex virus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HSV Infection
- What is being tested?
- walnut extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 27 Nov 2007to 28 Jan 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
About this study
Official title: Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex Mucocutaneous Infections and the Prevention of Recurrences: A Pilot Study
Study aimed to evaluate the efficacy and tolerance of Lazolex®, an emollient gel, to treat mucocutaneous lesions caused by herpes simplex virus.
Read the 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.
- Conditions
- HSV Infection
- Being tested
- walnut extract
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walnut extractDrug
Also called Lazolex gel
Four times a day over a 10-day period
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: walnut extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 days
Change in outbreak frequency
Change in outbreaks along time
Measured: 4 years
Secondary outcomes (2)
The degree of patient satisfaction
The level of patient satisfaction with treatment efficacy was categorized as high, medium, or low using a self-questionnaire.
Measured: 10 days
Number of complaints and symptoms
Tolerance outcomes were evaluated using both objective and subjective criteria. The objective criteria included the comparison of laboratory tests and physical examinations before and after Lazolex® Gel treatment. The subjective criteria included complaints and symptoms reported by patients. In the event of adverse reactions, they were assessed by attending physicians. Individual tolerance was categorized as follows:
Very satisfactory: No clinically significant changes in physical examination or laboratory tests, and no adverse reactions.
Satisfactory: Insignificant changes in physical examination or laboratory tests, or mild adverse reactions that do not require a change in treatment.
Unsatisfactory: Significant changes in physical examination or laboratory tests and/or the occurrence of adverse reactions that require the withdrawal of the product, as well as prescribing treatment to address the adverse reaction
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start27 Nov 2007
- Primary completion28 Dec 2007
- Study completion28 Jan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HSV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Lazolex gel
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iveriapharma LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tina A. Kituashvili, Ph.D,, Principal investigator, National Center of Dermatology and Venereology, Tblisi (Georgia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089252
- Sponsor's protocol ID
- CT-000032
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36437891
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex Mucocutaneous Infections and the Prevention of Recurrences: A Pilot Study
- ClinicalTrials.gov ID
- NCT06089252
- Acronym / sponsor ID
- CT-000032
- Conditions
- HSV Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Iveriapharma LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2007 (actual)
- Primary completion
- 28 Dec 2007 (actual)
- Study completion
- 28 Jan 2008 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Lazolex gel
| Arm | Type | Receives |
|---|---|---|
| HSV-1, HSV-2 | Other | Drug: walnut extractAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- abnormal laboratory results,
- hypersensitivity to the product or its components,
- pregnancy or breastfeeding,
- acute/ chronic renal or liver failure,
- history of migraine,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walnut extractAlso: Lazolex gelFour times a day over a 10-day period | Drug | HSV-1, HSV-2 |
Primary outcome
Course of the disease
Time frame: 10 days
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.
Change in outbreak frequency
Time frame: 10 days
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.
Change in outbreak frequency
Time frame: 4 years
Change in outbreaks along time
2 secondary outcomes
The degree of patient satisfaction
Time frame: 10 days
Number of complaints and symptoms
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Results publication: PubMed 36437891Kituashvili 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.
- Can J Infect Dis Med MicrobiolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina A. Kituashvili, Ph.D, principal investigator
National Center of Dermatology and Venereology, Tblisi (Georgia)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing walnut extract in people with HSV Infection, run by Iveriapharma LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of the disease (time frame: 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06089252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.