Clinical trial · Interventional
Pain Management During a Photodynamic Therapy Session on the Vertex for Actinic Keratosis: Tumescent Anesthesia Interest
Tumescent Anesthesia Interest in Pain Management During a Dynamic Phototherapy (PTD) Session in Vertex Actinic Keratosis Treatment: a Single-center Prospective Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
| Analgesia | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Phototerapy | — | UNRESOLVED | — |
| Vertex | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Arm (Paracetamol) | Drug | — | UNRESOLVED |
| Procedure (Tumesent anesthesia) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tumescent anesthesia
- description
- Patient who will receive tumescent anesthesia as analgesic treatment
- interventionNames
- Drug: Procedure (Tumesent anesthesia)
- type
- ACTIVE_COMPARATOR
- label
- Painkillers and cold water
- description
- Patient who will receive painkillers 1 hour before photodynamic therapy and cold water during session as analgesic treatment
- interventionNames
- Drug: Control Arm (Paracetamol)
Primary outcomes (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available