Clinical trial · Interventional
Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis
Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis#a Randomized, Open-label Trial
NCT04396184CI-TRIAL-00045181unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#ALA-PDT) to a conventional regimen for treatment of Actinic Keratosis. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminolevulinic acid photodynamic therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Painless Photodynamic Therapy(P-PDT) group
- description
- The painless photodynamic therapy group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 288 J/cm2) after applying 5% 5-aminolevulinic acid#ALA#cream for 30min. A repeat treatment was administered once every two weeks for 3 times.
- interventionNames
- Procedure: Aminolevulinic acid photodynamic therapy
- type
- ACTIVE_COMPARATOR
- label
- Conventional Photodynamic Therapy(C-PDT) group
- description
- The conventional photodynamic therapy(C-PDT) group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 140 J/cm2) after applying 5% 5-aminolevulinic acid cream for 3h.A repeat treatment was administered once every two weeks for 3 times.
- interventionNames
- Procedure: Aminolevulinic acid photodynamic therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinical diagnosed with AK (OLSEN classification grade I, II, III), aged \> 18 years (Because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients \<18 years of age, children are excluded from this study); 2. All patients are unfit and reluctant to undergo surgery for any reasons, and volunteered to participate in the study and ability to understand and the willingness to sign a written informed consent. Patents are willing to pay for the treatment, and agreed to take a picture of the skin lesions. Exclusion Criteria: 1. Those who had ALA-PDT and any other studies that affect this study within 12 weeks ; 2. There are other facial diseases that may affect the efficacy evaluation, such as other photodermatosis; 3. Take phototoxic or photosensitizer within 8 weeks; 4. Clinical and / or pathological prove that the tumor has invaded other organs or tissues; 5. Serious immunocompromised persons; 6. scar constitution; 7. Patients are known to have skin photosensitivity, porphyria, or allergies to ALA, light or lidocaine; 8. Persons are suffering from severe internal diseases, mental and mental illness, infectious diseases or pregnant or lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.