Treatment of Herpes Labialis by Photodynamic Therapy
Condition: Photodynamic Therapy; Herpes Simplex, Labial
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): photodynamic therapy herpes labialis
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: photodynamic therapy; herpes labialis; herpes simplex; laser