Clinical trial NCT04037475: Treatment of Herpes Labialis by Photodynamic Therapy
Official title: Treatment of Herpes Labialis by Photodynamic Therapy: Controlled, Prospective, Randomized, Double-blind Protocol Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photodynamic Therapy
Herpes Simplex, Labial
Keywords: photodynamic therapy
herpes labialis
herpes simplex
laser
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the resolution time of the lesions
timeFrame: through study completion on average of one year
Secondary outcomes:
measure: Evaluate if the amount of HSV-1 decreases after treatment with PDT
timeFrame: through study completion on average of three years
measure: evaluation of saliva cytokines IL-6, IL-1β, IL-8, TNF-α (tumor necrosis factor) and IL-10 (interleukine)
timeFrame: through study completion on average of three years
measure: presence of pain: visual analog scale
timeFrame: through study completion on average of three years
measure: Oral health impact profile (Ohip-14)
timeFrame: through study completion on average of three years
measure: Temperature
timeFrame: through study completion on average of three years
measure: evaluation of HSL lesions cytokines IL-6, IL-1β, IL-8, TNF-α (tumor necrosis factor) and IL-10 (interleukine)
timeFrame: through study completion on average of three years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Anna Carolina R.T. Horliana
state: SP
Study officials:
References:
citation: Ramalho KM, Rocha RG, Correa-Aranha AC, Cunha SR, Simoes A, Campos L, Eduardo Cde P. Treatment of herpes simplex labialis in macule and vesicle phases with photodynamic therapy. Report of two cases. Photodiagnosis Photodyn Ther. 2015 Jun;12(2):321-3. doi: 10.1016/j.pdpdt.2015.02.005. Epub 2015 Mar 10. No abstract available.
citation: Marotti J, Aranha AC, Eduardo Cde P, Ribeiro MS. Photodynamic therapy can be effective as a treatment for herpes simplex labialis. Photomed Laser Surg. 2009 Apr;27(2):357-63. doi: 10.1089/pho.2008.2268.
citation: Palmieri M, Ornaghi M, Martins VAO, Correa L, Brandao TB, Ribeiro ACDP, Sumita LM, Tozetto-Mendoza TR, Pannuti CS, Braz-Silva PH. Oral shedding of human herpesviruses in patients undergoing radiotherapy/chemotherapy for head and neck squamous cell carcinoma is not affected by xerostomia. J Oral Microbiol. 2018 May 28;10(1):1476643. doi: 10.1080/20002297.2018.1476643. eCollection 2018.
citation: La Selva A, Negreiros RM, Bezerra DT, Rosa EP, Pavesi VCS, Navarro RS, Bello-Silva MS, Ramalho KM, Aranha ACC, Braz-Silva PH, Fernandes KPS, Bussadori SK, Horliana ACRT. Treatment of herpes labialis by photodynamic therapy: Study protocol clinical trial (SPIRIT compliant). Medicine (Baltimore). 2020 Mar;99(12):e19500. doi: 10.1097/MD.0000000000019500.