Pain Management During a Photodynamic Therapy Session on the Vertex for Actinic Keratosis: Tumescent Anesthesia Interest

Study Overview
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Brief Summary
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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)

Official Title
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Tumescent Anesthesia Interest in Pain Management During a Dynamic Phototherapy (PTD) Session in Vertex Actinic Keratosis Treatment: a Single-center Prospective Randomized Study

Conditions
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Pain, Actinic Keratosis, Analgesia, Phototerapy, Vertex

Intervention / Treatment
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* Drug: Procedure (Tumesent anesthesia)
* Drug: Control Arm (Paracetamol)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tumescent anesthesia<br>Patient who will receive tumescent anesthesia as analgesic treatment | Drug: Procedure (Tumesent anesthesia)<br>* Photodynamic therapy of vertex with a solution of 180 ml of tumescent anesthesia diffused over 1 hour in three different sub-deceasing points.<br>|
| Active Comparator: Painkillers and cold water<br>Patient who will receive painkillers 1 hour before photodynamic therapy and cold water during session as analgesic treatment | Drug: Control Arm (Paracetamol)<br>* Photodynamic therapy of vertex with 1g of paracetamol intake 1 hour before cold water is applied during the session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Score of the maximum numerical pain assessment scale from 0 to 10 (0=no pain; 10= pain as bas as can be) felt during the dynamic phototherapy session in both groups. This score will be collected at the end of the session. | 8 minutes |