Status:
UNKNOWN
Pain Management During a Photodynamic Therapy Session on the Vertex for Actinic Keratosis: Tumescent Anesthesia Interest
Lead Sponsor:
Poitiers University Hospital
Conditions:
Pain
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
NA
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, r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04779255
Start Date
July 28 2021
End Date
November 1 2022
Last Update
September 29 2021
Active Locations (1)
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1
CHU
Poitiers, France, 86000