Clinical trial NCT02976727: Efficacy of Topical Calcipotriol-assisted AFL-PDT in Actinic Keratosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Actinic Dermatosis
Keywords: Vitamin D
Calcipotriol
Ablative fractional laser
Actinic keratosis
Photodynamic therapy
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences of short-term complete response rates between VitD-AFL-PDT and AFL-PDT
timeFrame: Short-term complete response rates were evaluated at 3 months after treatment
measure: Differences of long-term complete response rates between VitD-AFL-PDT and AFL-PDT
timeFrame: Long-term complete response rates were evaluated at 12 months
measure: Difference of the recurrence rates between VitD-AFL-PDT and AFL-PDT
timeFrame: Recurrence rates were evaluated respectively at 12 months after treatment.
Secondary outcomes:
measure: Differences of cosmetic outcomes between VitD-AFL-PDT and AFL-PDT
timeFrame: The overall cosmetic outcome was assessed 12 months after treatment
measure: Difference of adverse events (erythema, post-inflammatory hyperpigmentation, edema, itching, oozing, bleeding) rates between VitD-AFL-PDT and AFL-PDT
timeFrame: Within 12 months after each treatment
Other outcomes:
measure: Differences of the fluorescence intensity between VitD-AFL-PDT and AFL-PDT
timeFrame: After 3 hours of application with MAL, fluorescence intensity imaging was assessed 10 minutes before illumination.
Locations:
city: Busan, Seo-gu, Korea, Republic of, 602-715
country: Korea, Republic of
facility: Dong-A University
Study officials:
References: