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

September 28, 2021 updated by: Poitiers University Hospital

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Poitiers, France, 86000
        • Recruiting
        • CHU
        • Contact:
          • BOUTIN Damien, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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.
Time Frame: 8 minutes

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-000304-38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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