Clinical trial · Interventional
Efficacy of Topical Calcipotriol-assisted AFL-PDT in Actinic Keratosis
Efficacy of Topical Calcipotriol-assisted Ablative Fractional Laser Photodynamic Therapy for the Treatment of Actinic Keratosis: 12-month Follow-up Results of a Prospective, Randomised, Comparative Trial
NCT02976727CI-TRIAL-00024931completedPhase 1ClinicalTrials.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)
Vitamin D(Vit D) is a pro-differentiation agent that enhances the accumulation of protoporphyrin IX (PpIX) after MAL(methyl-aminolevulinate) incubation in actinic keratosis and may have significant benefit for the treatment of actinic keratosis by ablative fractional laser-primed photodynamic therapy (AFL-PDT).
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 Dermatosis | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2940-nm Er:YAG AFL pretreatment | Device | — | UNRESOLVED |
| irradiation with red light-emitting diode lamp | Device | — | UNRESOLVED |
| lidocaine/prilocaine (5%) application | Drug | — | UNRESOLVED |
| MAL application | Drug | — | UNRESOLVED |
| Measurements of the fluorescence intensity | Other | — | UNRESOLVED |
| Placebo cream application | Drug | — | UNRESOLVED |
| Topical Vitamin D (Calcipotriol) application | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GroupA (Vit-D pretreated AFL-PDT group )
- description
- Group A was treated with topical VitD-assisted AFL-PDT
- interventionNames
- Drug: Topical Vitamin D (Calcipotriol) application
- Drug: lidocaine/prilocaine (5%) application
- Device: 2940-nm Er:YAG AFL pretreatment
- Drug: MAL application
- Other: Measurements of the fluorescence intensity
- Device: irradiation with red light-emitting diode lamp
- type
- ACTIVE_COMPARATOR
- label
- GroupB (Conventional AFL PDT group )
- description
- Group B was treated with conventional AFL-PDT
- interventionNames
- Drug: Placebo cream application
- Drug: lidocaine/prilocaine (5%) application
- Device: 2940-nm Er:YAG AFL pretreatment
- Drug: MAL application
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Korean patients aged ≥ 18 years who had biopsy-confirmed Actinic keratosis lesions Exclusion Criteria: * calcium metabolic disorder patients * photosensitivity disorder patients * lactating or pregnant women * patients with porphyria or a known allergy to any of the constituents of the MAL cream and lidocaine * patients with systemic disease, history of malignant melanoma, tendency of melasma development or keloid formation, any AK treatment of the area in the previous 4 weeks, or any conditions associated with a risk of poor protocol compliance; and patients on immunosuppressive treatment
References
Publications (0)
Data not yet available
No reference posted for this study.