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Herpes Labialis clinical trials

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NCT ID: NCT06135844 Recruiting - Virus Clinical Trials

Hand Sanitizer Use for Herpes Simplex Virus-1

Start date: April 8, 2022
Phase: Early Phase 1
Study type: Interventional

The purpose of this pilot study is to determine if the use of Purell hand sanitizer alters the duration, level of pain and discomfort during treatment, and the size of the HSV-1 lesion. The duration of an HSV-1 (herpes) lesion is the primary endpoint for this study. Size, pain, and discomfort are the secondary endpoints.

NCT ID: NCT05796635 Completed - Cold Sores Clinical Trials

An Investigation Into the Efficacy of Herpecin L at Reducing the Frequency and Severity of Cold Sores

Start date: January 4, 2023
Phase: N/A
Study type: Interventional

Focus Consumer Healthcare has developed Herpecin L. Herpecin L combines many different ingredients hypothesized to promote quick healing and symptom reduction from cold sores.

NCT ID: NCT05098938 Active, not recruiting - Clinical trials for Recurrent Herpes Labialis

A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally

Start date: November 23, 2021
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people who have recurrent herpes labialis, also known as cold sores. This is a type of viral infection that causes redness and blisters on the mouth and lip and that recurs. Herpes labialis is caused by a virus called the herpes simplex virus (HSV). The infection is spread when a person comes into direct contact with someone else who has the infection. Once a person becomes infected with HSV, the virus multiplies and spreads, which can cause redness and blistering on the mouth and lip. The blisters crust over and heal. Once healed, the virus is said to go into an "inactive" phase. This means the virus does not cause any symptoms, but still remains in the body. HSV can then become "active" again. This means causing cold sore lesions to reappear. HSV can become active in different ways. Some of these include when a person has a fever, comes into contact with strong sunlight or has a condition that lowers one's immune system It can also happen during a woman's menstrual cycle, also called a period. In this study, the researchers want to gather additional data on acyclovir 50 mg tablet, an available treatment for herpes labialis. It is a buccal tablet that sticks to the gum inside the mouth and directly treats the infected area to help stop the HSV from multiplying and spreading. In this study, the researchers want to compare the efficacy of acyclovir 50 mg buccal tablets versus placebo in the treatment of herpes labialis. A placebo is a treatment that looks like the study medicine but does not have any medicine in it. Study participants will include those who have had at least 4 episodes of herpes labialis within the past 12 months prior to joining the study. To compare the study treatments, the researchers will measure the "duration of episode" (DOE) for each participant. DOE is amount of time it takes for symptoms to disappear and for herpes labialis lesions to heal after taking the study treatment. A doctor will look at the participants' symptom scores and facial images to determine the DOE. Assessments will be done over a period of 14 days. The participants in this study will apply either acyclovir 50mg buccal tablet or the placebo as a tablet to the upper gum 1 time. There will be a 2 week treatment phase and a 12 month follow up phase. The participants in this study will not be required to visit the study site. Instead, the participants will have virtual meetings with the study doctors from their homes using the internet. During the treatment phase, there will be 2 meetings. Throughout the follow up phase, the doctors will call the participants 4 times. Each participant will be in the study for about 20 months. During the treatment phase of the study, the participants will: - take their blood pressure and pulse - check their mouth health through a questionnaire - take pictures of their face and herpes labialis symptoms During the whole study the participants will answer questions about how they are feeling, what medications they are taking, and what adverse events they are having. The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT04539483 Terminated - Herpes Labialis Clinical Trials

Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection

MATCH-1
Start date: October 8, 2020
Phase: Phase 2
Study type: Interventional

This is a phase II, double-blind, randomised, controlled, multicentre trial of topical HDIT101 versus placebo. HSV-1-positive patients with at least 6 orolabial herpes lesions in the last 12 months can be included. The patients need to present with 3 herpes lesions within a 9 months observation phase. With the occurrence of the third lesion, the patients will enter the 12 months treatment phase and will be randomized in a 2:1 ratio to topical HDIT or placebo applied over 2 days. A potential fourth lesion will also be treated with the blinded study medication and additional lesions will be documented. In a 12 months post-trial follow-up phase, further information on the occurence of lesions will be collected 4 times by phone. Study duration per patient will be up to 21 months plus 12 months post-trial follow-up by phone. Patients need to come for study visits up to 9 times.

NCT ID: NCT04037475 Completed - Clinical trials for Photodynamic Therapy

Treatment of Herpes Labialis by Photodynamic Therapy

Herpes
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Lesions of herpes labialis are caused by the herpes simplex virus type 1 (HSV-1) and cause pain and aesthetic compromise. It is characterized by the formation of small vesicles that coalesce and rupture forming extremely painful ulcers, that evolve to crusts, dry desquamations until their complete remission. Currently, the treatment of these lesions is done with acyclovir. Although it diminishes the symptomatology, it causes viral resistance and does not prevent the recurrence of the lesions. It is known that photodynamic therapy (PDT) has numerous advantages, among them: the reduction of the time of remission, and does not cause resistance. A total of 30 patients with herpes labialis in the prodromal stage of vesicles, ulcers, and crusts will be selected to participate in the study and randomized into two groups: G1 control and G2 experimental. After signing informed consent, patients in group G1 will undergo the standard gold treatment for cold sores with acyclovir and simulated PDT treatment. Patients in the experimental G2 group will be treated simulating the gold standard treatment of herpes labialis (placebo) and PDT.

NCT ID: NCT03977792 Not yet recruiting - Clinical trials for Recurrent Herpes Labialis

An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis

Start date: September 2020
Phase: Phase 2
Study type: Interventional

BOR15001L7 is a natural product. The primary objective of this study is to demonstrate its non-inferiority to docosanol 10% based on the healing time of cold sores in patients with recurrent herpes labialis.

NCT ID: NCT03661541 Completed - Herpes Labialis Clinical Trials

Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1)

Start date: March 2, 2017
Phase: Phase 1
Study type: Interventional

Subjects were recruited who were positive for antibody against herpes simplex virus type 1 (HSV-1) and self-reported having in the previous 12 months - 6 or more herpes labialis outbreaks (group A), - 1 or 2 outbreaks (group B), or - zero outbreaks (group C). Twelve subjects in each group were recruited. Blood was collected from these persons and peripheral blood mononuclear cells (PBMCs) isolated and tested for proliferation in vitro when stimulated with HSV-1-infected cell extracts, free HSV-1 virus, or Candida albicans extract. Candida albicans is a ubiquitous infectious fungus and its extract is used as a test of general immune response. RNA was also isolated from the PBMCs after incubation in the three stimuli and expression of 41 immune-related genes quantified by quantitative real-time PCR. Also serum anti-HSV-1 IgG levels were quantified. After the blood collection on day 1, the persons in group A (frequent cold sore sufferers) were treated with a single topical application of 2% squaric acid dibutyl ester (SADBE) in DMSO, applied to the inner aspect of the upper arm. These subjects returned on days 15 and 57 for blood collection, and their PBMCs were tested again on those dates for proliferation in vitro against the same stimuli and for gene expression and for serum anti-HSV-1 IgG levels.

NCT ID: NCT03521479 Terminated - Herpes Labialis Clinical Trials

A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis

Start date: March 12, 2018
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess local and generalized adverse events with repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months). Secondary Objective: To assess efficacy of repeat topical application of 2% and 0.5% SADBE in the prevention of herpes labialis episodes.

NCT ID: NCT03469232 Recruiting - Clinical trials for Recurrent Aphthous Stomatitis

Effectiveness and Clinical Mechanism of Huanglian-Jiedu Decoction in Patients With Intense-exuberant Stomach Fire Syndrome

Start date: April 4, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical research focus on evaluating the effectiveness of Huanglian-Jiedu Decoction in patients with intense-exuberant stomach fire syndrome (one of the common TCM syndrome)of acute pericoronitis,minor recurrent aphthous stomatitis and recurrent herpes simplex labialis,meanwhile, exploring the pharmacological mechanism and potential biomarkers of this traditional formula.

NCT ID: NCT03310294 Completed - Herpes Labialis Clinical Trials

Immune Evidence to the Consumption of Lactobacillus GG and FOS Consumption in Patients With Herpes Labialis

EVIM2
Start date: September 14, 2010
Phase: N/A
Study type: Interventional

Herpes labialis (HL) is the result of the presence of a virus called HSV-1 and is a common disease. Because of its visibility due to cold sores it has a serious impact on social life. Until now there is no effective treatment to prevent virus outbreaks. However, prebiotics and probiotics have both been shown to have a favorable and supportive effect on the immune system in different health conditions such as influenza, atopic dermatitis and diarrhea, so it is possible that they are able to have a favourable effect also on HL. A recently completed pilot clinical trial (Protocol Number 08-SBUS-2-GRA-01, EVIM-1) was completed using a fermented milk (minidrink) containing a combination of L. rhamnosus and FOS; it showed promising results in the reduction of HL recurrences in a population of 78 subjects with HSV-1. The study investigated the effect of pre- or probiotics or a combination of the two on the recurrence of HL lesions as well as on the immune system in general, showing that the consumption of a minidrink containing the probiotic L. rhamnosus or a minidrink containing a combination of L. rhamnosus and FOS reduced the occurrence and the incidence of recurrent HL lesions. Aim of this study: corroborate whether the consumption of a minidrink containing a combination of L. rhamnosus and FOS results in less recurrence and a better progression of HL lesion, in a larger population. In addition, the response of the consumption of the minidrink on the QoL and the response on immunity specific biomarkers were evaluated. Design: 152 patients were eligible to participate in the study and after a run-in period of two weeks consuming a placebo minidrink were randomized to one of the two experimental study groups: placebo minidrink (n=79) and a minidrink containing a combination of a pre- and probiotic (n=78). These minidrinks were consumed until the end of the study (day 140). At day 33 of the study the lip most prone to the development of a lesion was stimulated with UVB to provoke a lesion. During the entire study period subjects were checked for any clinical signs of a lesion, completed a self-assessment regarding the lesion and a QoL questionnaire at baseline (day 14), at day 49 and the end of the study (day 140). In addition, a blood sample was collected at baseline, at day 49 and at the end of the study to be analyzed for HSV-specific antibody concentrations , to check immune system specific functions.