PainANTUKANCT04779255
Pain Management During a Photodynamic Therapy Session on the Vertex for Actinic Keratosis: Tumescent Anesthesia Interest
A study testing Procedure (Tumesent anesthesia) in people with Pain and Actinic Keratosis, run by Poitiers University Hospital at 1 site in France.
Trial 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, randomized, controlled, open-ended study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Actinic Keratosis, Analgesia
- What is being tested?
- Procedure (Tumesent anesthesia)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2021to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
- Conditions
- Pain, Actinic Keratosis, Analgesia, Phototerapy, Vertex
- Being tested
- Procedure (Tumesent anesthesia), Control Arm (Paracetamol)
- Medical subject headings
- Pain, Keratosis, Actinic, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure (Tumesent anesthesia)Drug
Photodynamic therapy of vertex with a solution of 180 ml of tumescent anesthesia diffused over 1 hour in three different sub-deceasing points.
Control Arm (Paracetamol)Drug
Photodynamic therapy of vertex with 1g of paracetamol intake 1 hour before cold water is applied during the session.
| Study group | Role | What they receive |
|---|---|---|
| Tumescent anesthesia | Experimental | Patient who will receive tumescent anesthesia as analgesic treatment Receives: Drug: Procedure (Tumesent anesthesia) |
| Painkillers and cold water | Active comparator | Patient who will receive painkillers 1 hour before photodynamic therapy and cold water during session as analgesic treatment Receives: Drug: Control Arm (Paracetamol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start28 Jul 2021
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779255
- Sponsor's protocol ID
- 2021-000304-38
- Acronym
- ANTUKA
- Status last verified
- Sep 2021
- First submitted
- 26 Feb 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumescent Anesthesia Interest in Pain Management During a Dynamic Phototherapy (PTD) Session in Vertex Actinic Keratosis Treatment: a Single-center Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04779255
- Acronym / sponsor ID
- ANTUKA / 2021-000304-38
- Conditions
- Pain, Actinic Keratosis, Analgesia, Phototerapy, Vertex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumescent anesthesia | Experimental | Drug: Procedure (Tumesent anesthesia)Patient who will receive tumescent anesthesia as analgesic treatment |
| Painkillers and cold water | Active comparator | Drug: Control Arm (Paracetamol)Patient who will receive painkillers 1 hour before photodynamic therapy and cold water during session as analgesic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Tumescent anesthesia |
| Control Arm (Paracetamol)Photodynamic therapy of vertex with 1g of paracetamol intake 1 hour before cold water is applied during the session. | Drug | Painkillers and cold water |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure (Tumesent anesthesia) in people with Pain and Actinic Keratosis, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damien BOUTIN, Dr (05 49 44 44 59 ext. +33, damien.boutin@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.