Actinic Dermatosis Clinical Trial
Official title:
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
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).
Photodynamic therapy (PDT) with methyl-aminolevulinate (MAL) is effective in the treatment
of actinic keratosis (AK). Many strategies have been studied to improve the production of
protoporphyrin IX (PpIX), to improve efficacy of PDT. Pre-treatment of the skin with
fractional laser resurfacing is a novel alternative technique to improve the efficacy of PDT
for AK. The investigators' previous studies showed that ablative fractional laser primed PDT
(AFL-PDT) offered higher efficacy than conventional MAL-PDT in the treatment of AK. But,
reduced response rates are also observed in thicker skin lesions, which may be due to
insufficient PpIX accumulation within the target tissue.
Cellular differentiation leads to increased synthesis of PpIX from MAL and consecutively,
differentiation therapy enhances photosensitization effect. Topical calcipotriol is a
well-known pro-differentiation hormone and was demonstrated to influence the effect of PDT
on keratinocytes.
The aim of this study was to evaluate efficacy of topical vitamin D in AFL-PDT for AK
treatment. Consequently, the investigator compared efficacy, recurrence rate, cosmetic
outcome and safety between VitD - AFL-PDT and conventional AFL-PDT.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03325803 -
Efficacy in Ablative Fractional Laser Assisted Photodynamic Therapy According to Ablative Depth for Actinic Keratosis
|
Phase 1 |