Tumescent anesthesia efficiency in pain management during a dynamic phototherapy session in vertex actinic keratosis treatment: a single-center prospective randomized study.

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-000304-38-FR
• Lead Sponsor: CHU de Poitiers

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-15
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 48

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

- Patients with recurrent porphyria
- Severe hepato-cellular insufficient patients
- Kidney failure 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To 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;Secondary Objective: Compare between the control group and the tumescent anesthesia management group: <br>-The efficacy of PTD treatment at 3 months <br>-Tolerance of PTD treatment <br>-Tolerance of care for PTD Efficiency in pain management based on the surface of the vertex affected by actinic keratoses<br><br>;Primary end point(s): Score of the maximum numerical pain assessment scale (from 0 to 10) during the dynamic phototherapy session in both groups. <br><br>;Timepoint(s) of evaluation of this end point: the day of the dynamic phototherapy session