Efficacy of Topical Calcipotriol-assisted AFL-PDT in Actinic Keratosis

Dong-A University

Status and phase: Completed; Phase 1

Conditions: Actinic Dermatosis

Treatments: Drug: Topical Vitamin D (Calcipotriol) application; Device: irradiation with red light-emitting diode lamp; Drug: lidocaine/prilocaine (5%) application; Drug: MAL application; Device: 2940-nm Er:YAG AFL pretreatment; Drug: Placebo cream application; Other: Measurements of the fluorescence intensity

Study type: Interventional

Funder types: Other

Identifiers

NCT02976727

DAUderma-07

Details and patient eligibility

About

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).

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

GroupA (Vit-D pretreated AFL-PDT group )

Experimental group

Description:

Group A was treated with topical VitD-assisted AFL-PDT

Treatment:

Drug: MAL application

Device: 2940-nm Er:YAG AFL pretreatment

Other: Measurements of the fluorescence intensity

Drug: lidocaine/prilocaine (5%) application

Device: irradiation with red light-emitting diode lamp

Drug: Topical Vitamin D (Calcipotriol) application

GroupB (Conventional AFL PDT group )

Active Comparator group

Description:

Group B was treated with conventional AFL-PDT

Treatment:

Drug: MAL application

Device: 2940-nm Er:YAG AFL pretreatment

Other: Measurements of the fluorescence intensity

Drug: Placebo cream application

Drug: lidocaine/prilocaine (5%) application

Device: irradiation with red light-emitting diode lamp