Treatment of Herpes Labialis by Photodynamic Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Activation of Alternative Cellular Energy (ACE) Pathway in the Therapy of Herpes Virus Infections

NCT00642785

Herpes Simplex Herpes Zoster

COMPLETED

Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis

NCT00736437

Herpes Labialis

COMPLETED PHASE2

Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis

NCT01971385

Herpes Labialis

COMPLETED PHASE1

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

NCT03521479

Herpes Labialis HSV

TERMINATED PHASE2

Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis

NCT02965781

Herpes Labialis Cold Sore

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Materials and methods: 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 TCLE and TA, 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. In all patients will be collected saliva samples for analysis of cytokines, and will be performed exfoliative cytology in the lesions. The pain will be assessed through a pain scale and a questionnaire of quality of life-related to oral health (Ohip- 14) will be given to them. Patients will continue to be followed up after 7 days, 1 month, 3 months, 6 months and 1 year and, if there is a recurrence of the lesion, they will contact the researchers.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Photodynamic Therapy Herpes Simplex, Labial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

24 individuals will be randomly divided into 2 groups: G1 (control group) - conventional treatment with acyclovir and simulation of treatment with photodynamic therapy; G2 (experimental group) - photodynamic therapy placebo ointment simulating acyclovir cream.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Only the researcher responsible for performing the treatments (which will open the envelopes of the randomization) will know which treatment was assigned to each patient. The identification of each group will be revealed only after the statistical analysis of the data for all those involved in the study by this researcher. Therefore, the researcher responsible for data collection, the microbiologist and the statistician will be blind regarding the treatments assigned to the groups. The patient will also be blind to the type of treatment performed, since the treatment of the lesion will be identical in both groups and the treatment with PDT will be simulated in the control group. Aciclovir placebo will be used in the experimental group, so the patient will not know which treatment will be effective.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control (placebo)

The patients will receive an agent with the same vehicle as methylene blue to mimic irrigation with the photosensitizer and the laser will be switched off at the time of application. The placebo PDT procedures will be performed on the lesion: Application of methylene blue placebo with a carpule syringe and needle (with stop and without bevel) inside the lesions; 1 minute of pre-irradiation will be expected. The irradiations will be performed with the same device positioned in the same way and at the same time of application, however, the laser will be turned off. The beep sound will be recorded and turned on during application to blind treatment to the patient. The patient will receive a catheter with acyclovir cream and will be advised to spread on the lesions four times a day for 7 days, which will be their return for reevaluation. It will be washed in abundance with saline (saline solution) until the total removal of the placebo from the photosensitizer.

Group Type PLACEBO_COMPARATOR

photodynamic therapy herpes labialis

Intervention Type DEVICE

Patients will receive Photodynamic Therapy (PDT), irradiations will be performed with the Laser Duo® red laser diode (MMOptics, São Carlos, SP, Brazil) with a wavelength of 660 nm, with a power of 100 mW, the energy density of 300 J / cm², with energy of 3 J in the center of the lesion for 30 seconds. The laser will be positioned in direct contact with the lesion, perpendicular, applied centrally to each isolated lesion that presents with fixed energy per point of 3J. Wash in abundance with saline solution until the removal of the photosensitizer is complete. All treatment proposed in group 1 (simulation of PDT + delivery of aciclovir cream) in each patient will be concluded in a single session. Treatment for group 2 (PDT + placebo cream) will also be completed in a single session. All possible adverse effects will be noted and qualified during the treatment protocol and maintenance period (3/3 months) using the questionnaire developed for this protocol.

experimental group

Patients will be treated with photodynamic therapy and will receive a placebo ointment simulating acyclovir cream. If the lesions are in the vesicle phase, they will be ruptured with a sterile needle. The methylene blue solution at 0.005% concentration will be gently placed on the lesions. Application of methylene blue on the lesions.1 minute of pre-irradiation will be expected. The irradiations will be performed with the Laser Duo® with a wavelength of 660 nm, with a power of 100 mW(milliwatts), the energy density of 300 J / cm², with the energy of 3 J (joules) in the center of the lesion for 30 seconds. The laser will be positioned in direct contact with the lesion, perpendicular, applied centrally to each lesion with energy per point of 3J. Wash in abundance with saline solution until the removal of the photosensitizer is complete. Patients will receive a tube with a placebo cream simulating aciclovir and the same will be advised to spread the cream 4 times per day for 7 days.

Group Type EXPERIMENTAL

photodynamic therapy herpes labialis

Intervention Type DEVICE

Patients will receive Photodynamic Therapy (PDT), irradiations will be performed with the Laser Duo® red laser diode (MMOptics, São Carlos, SP, Brazil) with a wavelength of 660 nm, with a power of 100 mW, the energy density of 300 J / cm², with energy of 3 J in the center of the lesion for 30 seconds. The laser will be positioned in direct contact with the lesion, perpendicular, applied centrally to each isolated lesion that presents with fixed energy per point of 3J. Wash in abundance with saline solution until the removal of the photosensitizer is complete. All treatment proposed in group 1 (simulation of PDT + delivery of aciclovir cream) in each patient will be concluded in a single session. Treatment for group 2 (PDT + placebo cream) will also be completed in a single session. All possible adverse effects will be noted and qualified during the treatment protocol and maintenance period (3/3 months) using the questionnaire developed for this protocol.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

photodynamic therapy herpes labialis

Patients will receive Photodynamic Therapy (PDT), irradiations will be performed with the Laser Duo® red laser diode (MMOptics, São Carlos, SP, Brazil) with a wavelength of 660 nm, with a power of 100 mW, the energy density of 300 J / cm², with energy of 3 J in the center of the lesion for 30 seconds. The laser will be positioned in direct contact with the lesion, perpendicular, applied centrally to each isolated lesion that presents with fixed energy per point of 3J. Wash in abundance with saline solution until the removal of the photosensitizer is complete. All treatment proposed in group 1 (simulation of PDT + delivery of aciclovir cream) in each patient will be concluded in a single session. Treatment for group 2 (PDT + placebo cream) will also be completed in a single session. All possible adverse effects will be noted and qualified during the treatment protocol and maintenance period (3/3 months) using the questionnaire developed for this protocol.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Patients of both sex,

* with no predilection for race or socioeconomic status,
* negative medical history

Exclusion Criteria

* Patients with a herpes infection in the dry desquamation stage will be excluded.
* Participants in continuous use of non-steroidal anti-inflammatory drugs and continued corticosteroid therapy for less than 1 week.
* Diabetic participants, smokers
* who need immunosuppressants,
* pregnant women and/or nursing mothers.
* HIV positive,
* hepatitis B or C.

Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes