Clinical trial · Interventional
Efficacy of AFL-assisted PDT With Short Incubation Time in Actinic Keratosis
Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy With Short Incubation Time for the Treatment of Facial and Scalp Actinic Keratosis: 12-month Follow-up Results of a Randomized, Prospective, Comparative Trial
- 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)
Photodynamic therapy (PDT) using methyl aminolevulinate (MAL) is an effective first-line treatment for actinic keratosis (AK). Erbium: yttrium-aluminium-garnet (Er:YAG) ablative fractional laser-assisted MAL-PDT (AFL-PDT) has shown significant benefit for the treatment of AK. However, knowledge on the optimal photosensitizer incubation time for AFL-PDT is limited
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2h-AFL-PDT | Drug | — | UNRESOLVED |
| 3h-AFL-PDT | Drug | — | UNRESOLVED |
| 3hr-MAL-PDT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 2h-AFL-PDT
- description
- All 440 AK lesions of the 93 patients were randomly assigned to treatment with MAL-PDT (3h-MAL-PDT) or AFL-PDT with 2 hours (2h-AFL-PDT) and 3 hours (3h-AFL-PDT) of incubation time, using restricted randomization, with a computer-generated program.
- interventionNames
- Drug: 2h-AFL-PDT
- type
- ACTIVE_COMPARATOR
- label
- 3hr-AFL-PDT
- description
- All 440 AK lesions of the 93 patients were randomly assigned to treatment with MAL-PDT (3h-MAL-PDT) or AFL-PDT with 2 hours (2h-AFL-PDT) and 3 hours (3h-AFL-PDT) of incubation time, using restricted randomization, with a computer-generated program.
- interventionNames
- Drug: 3h-AFL-PDT
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 87 Years
Show eligibility criteria text
Inclusion Criteria: * age \>18 years * the presence of 2-10 facial AK lesions Exclusion Criteria: * lactating or pregnant women * patients with porphyria * a known allergy to any of the constituents of the MAL cream and lidocaine * patients with systemic disease * history of malignant melanoma * tendency for melasma development or keloid formation * any AK treatment of the area in the previous 4 weeks * any conditions associated with a risk of poor protocol compliance * patients on immunosuppressive treatment
References
Publications (1)
- DERIVEDChoi SH, Kim KH, Song KH. Efficacy of ablative fractional laser-assisted photodynamic therapy with short-incubation time for the treatment of facial and scalp actinic keratosis: 12-month follow-up results of a randomized, prospective, comparative trial. J Eur Acad Dermatol Venereol. 2015 Aug;29(8):1598-605. doi: 10.1111/jdv.12953. Epub 2015 Feb 1. PMID 25640401