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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000304-38-FR

Enrollment

Registered

2021-02-15

Start date

2021-04-06

Completion date

Unknown

Last updated

2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: LIDOCAINE AGUETTANT 10 mg/ml Product Name: Lidocaïne Product Code: Lidocaïne Pharmaceutical Form: Solution for injection Trade Name: BICARBONATE DE SODIUM 4,2 % B. BRAUN Product Name: BIC

Eligibility

Sex/Gender

All

Inclusion 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 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

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.

Design outcomes

Primary

Measure	Time frame
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: - The efficacy of PTD treatment at 3 months - Tolerance of PTD treatment - Tolerance of care for PTD Efficiency in pain management based on the surface of the vertex affected by actinic keratoses ;Primary end point(s): Score of the maximum numerical pain assessment scale (from 0 to 10) during the dynamic phototherapy session in both groups. ;Timepoint(s) of evaluation of this end point: the day of the dynamic phototherapy session	—

Measure

Time frame

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: - The efficacy of PTD treatment at 3 months - Tolerance of PTD treatment - Tolerance of care for PTD Efficiency in pain management based on the surface of the vertex affected by actinic keratoses ;Primary end point(s): Score of the maximum numerical pain assessment scale (from 0 to 10) during the dynamic phototherapy session in both groups. ;Timepoint(s) of evaluation of this end point: the day of the dynamic phototherapy session

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Secondary

Measure	Time frame
Secondary end point(s): 1- Efficiency of the three-month PTD session, defined by: o Complete remission: no actinic keratosis lesion on the treated area o Partial remission of more than 50% of actinic keratoses to the treated area o Partial remission of less than 50% of actinic keratoses in the treated area o Lack of efficacy: persistence of the same number of actinic keratoses in the treated area 2-Tolerance of the PTD session defined by: o EN (from 0 no pain to 10 worst unimaginable pain) of maximum pain during the 8-minute session. o Number of sessions stopped prematurely based on analgesic treatment. o EN (from 0 no pain to 10 the worst unimaginable pain) of pain 24 hours after the session. 3-Tolerance of tumescent anesthesia defined by: o EN (from 0 no pain to 10 the worst unimaginable pain) to the pose of the epicranial micro-infuser after the gesture. o EN (from 0 no pain to 10 worst unimaginable pain) of maximum pain during skin infiltration by tumescent anesthesia after 1 hour. 4-Efficacy of tumescent anesthesia and analgia by paracetamol and cold-water vaporization depending on the size of the treated area defined by: o EN (from 0 no pain to 10 worst unimaginable pain) of maximum pain during PTD session in patients with an area of actinic keratoses = 50% of the total surface area of vertex o EN (from 0 no pain to 10 worst unimaginable pain) of maximum pain during PTD session in patients with an area of actinic keratoses > 50% of the total surface area of vertex ;Timepoint(s) of evaluation of this end point: 1-3 months 2-On the PTD day and 24h after PTD 3- After the pose of epicranial micro-infuser and after 1 hour of skin infiltration. 4-During and after PTD	—

Measure

Time frame

Secondary end point(s): 1- Efficiency of the three-month PTD session, defined by: o Complete remission: no actinic keratosis lesion on the treated area o Partial remission of more than 50% of actinic keratoses to the treated area o Partial remission of less than 50% of actinic keratoses in the treated area o Lack of efficacy: persistence of the same number of actinic keratoses in the treated area 2-Tolerance of the PTD session defined by: o EN (from 0 no pain to 10 worst unimaginable pain) of maximum pain during the 8-minute session. o Number of sessions stopped prematurely based on analgesic treatment. o EN (from 0 no pain to 10 the worst unimaginable pain) of pain 24 hours after the session. 3-Tolerance of tumescent anesthesia defined by: o EN (from 0 no pain to 10 the worst unimaginable pain) to the pose of the epicranial micro-infuser after the gesture. o EN (from 0 no pain to 10 worst unimaginable pain) of maximum pain during skin infiltration by tumescent anesthesia after 1 hour. 4-Efficacy of tumescent anesthesia and analgia by paracetamol and cold-water vaporization depending on the size of the treated area defined by: o EN (from 0 no pain to 10 worst unimaginable pain) of maximum pain during PTD session in patients with an area of actinic keratoses = 50% of the total surface area of vertex o EN (from 0 no pain to 10 worst unimaginable pain) of maximum pain during PTD session in patients with an area of actinic keratoses > 50% of the total surface area of vertex ;Timepoint(s) of evaluation of this end point: 1-3 months 2-On the PTD day and 24h after PTD 3- After the pose of epicranial micro-infuser and after 1 hour of skin infiltration. 4-During and after PTD

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Countries

France

Contacts

Public ContactABRIAT Fanny

CHU de Poitiers

fanny.abriat@chu-poitiers.fr+33549443796

Outcome results