Clinical trial NCT04779255: Pain Management During a Photodynamic Therapy Session on the Vertex for Actinic Keratosis: Tumescent Anesthesia Interest
Official title: Tumescent Anesthesia Interest in Pain Management During a Dynamic Phototherapy (PTD) Session in Vertex Actinic Keratosis Treatment: a Single-center Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Actinic Keratosis
Analgesia
Phototerapy
Vertex
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study focus on the efficacity of tumescent anesthesia in pain management during a photodynamic therapy on the vertex for treatment of actinic keratosis. To do this we carried out a prospective, randomized, controlled, open-ended study. Our aim is to show a 40% reduction in pain during photodynamic therapy session compared to a conventionally used analgesic method (paracetamol + cold water)


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18
* Diagnosis of clinical or histological actintic keratoses validated by a dermatologist
* More than 4 vertex actinic keratoses lesions that can be treated with a dynamic phototherapy session
* Free subject, without guardianship or curatorship or subordination
* Person affiliated or beneficiary of a social security plan
* Informed and signed consent by the patient after clear and fair information about the study

Exclusion Criteria:

* Known lidocaine hydrochlostate hypersensitivity, local amide-binding anesthetics or one of the excipients
* Hypersensitivity to paracetamol or one of the excipients
* Weight \< 50 kg
* Patients with an elongated TQ interval at the ECG (\>450 ms in men and \>470 ms in women)
* Patients with recurrent porphyria
* Severe hepato-cellular insufficient patients
* Patients who have received treatment for actinic keratoses in the last three months (cryotherapy, 5-fluorouracil, imiquinod, daylight-PTD)
* Patients who have already participated in this study
* People who do not have a social security plan or do not benefit from it through a third party.
* Persons with enhanced protection, namely minors, persons deprived of their liberty by judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally the sick in an emergency situation.
* Pregnant or lactating women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per bone, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).
* Concurrent participation in another clinical research study.

Primary outcomes:
measure: Pain Intensity Measure : evaluate the effectiveness of tumescent anesthesia compared to the control group in pain management during a dynamic vertex phototherapy session performed for the management of actinic keratoses.
timeFrame: 8 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU
Study officials:
References: