Treatment of Herpes Labialis by Photodynamic Therapy

University of Nove de Julho

Status: Completed

Conditions: Photodynamic Therapy; Herpes Simplex, Labial

Treatments: Device: photodynamic therapy herpes labialis

Study type: Interventional

Funder types: Other

Identifiers

NCT04037475

Herpes

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 12 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Control (placebo)

Placebo Comparator group

Description:

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.

Treatment:

Device: photodynamic therapy herpes labialis

experimental group

Experimental group

Description:

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.

Treatment:

Device: photodynamic therapy herpes labialis