Efficacy of Topical Calcipotriol-assisted AFL-PDT in Actinic Keratosis
- Conditions
- Actinic Dermatosis
- Interventions
- Drug: Placebo cream applicationDrug: lidocaine/prilocaine (5%) applicationDrug: MAL applicationOther: Measurements of the fluorescence intensityDevice: irradiation with red light-emitting diode lamp
- Registration Number
- NCT02976727
- Lead Sponsor
- Dong-A University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Korean patients aged ≥ 18 years who had biopsy-confirmed Actinic keratosis lesions
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description GroupB (Conventional AFL PDT group ) MAL application Group B was treated with conventional AFL-PDT GroupB (Conventional AFL PDT group ) Measurements of the fluorescence intensity Group B was treated with conventional AFL-PDT GroupA (Vit-D pretreated AFL-PDT group ) irradiation with red light-emitting diode lamp Group A was treated with topical VitD-assisted AFL-PDT GroupA (Vit-D pretreated AFL-PDT group ) Topical Vitamin D (Calcipotriol) application Group A was treated with topical VitD-assisted AFL-PDT GroupB (Conventional AFL PDT group ) Placebo cream application Group B was treated with conventional AFL-PDT GroupA (Vit-D pretreated AFL-PDT group ) lidocaine/prilocaine (5%) application Group A was treated with topical VitD-assisted AFL-PDT GroupA (Vit-D pretreated AFL-PDT group ) MAL application Group A was treated with topical VitD-assisted AFL-PDT GroupA (Vit-D pretreated AFL-PDT group ) Measurements of the fluorescence intensity Group A was treated with topical VitD-assisted AFL-PDT GroupB (Conventional AFL PDT group ) lidocaine/prilocaine (5%) application Group B was treated with conventional AFL-PDT GroupB (Conventional AFL PDT group ) irradiation with red light-emitting diode lamp Group B was treated with conventional AFL-PDT
- Primary Outcome Measures
Name Time Method Differences of short-term complete response rates between VitD-AFL-PDT and AFL-PDT Short-term complete response rates were evaluated at 3 months after treatment Lesion responses were classified as either a complete response (complete disappearance of the lesion) or a noncomplete response (incomplete disappearance)
Difference of the recurrence rates between VitD-AFL-PDT and AFL-PDT Recurrence rates were evaluated respectively at 12 months after treatment. In all cases of complete response, the patients were reviewed at 12 months to check for recurrence. Recurrence was assessed by inspection, dermoscopy, photography, palpation, and histologic findings. For the histopathologic evaluation of treatment response, at the 12-month follow-up visit, a 3-mm punch biopsy of the treated AK lesion was performed in all cases of clinically incomplete response.
Differences of long-term complete response rates between VitD-AFL-PDT and AFL-PDT Long-term complete response rates were evaluated at 12 months In all cases of complete response, the patients were reviewed at 12 months to check for recurrence. Recurrence was assessed by inspection, dermoscopy, photography, palpation, and histologic findings. For the histopathologic evaluation of treatment response, at the 12-month follow-up visit, a 3-mm punch biopsy of the treated AK lesion was performed in all cases of clinically incomplete response.
- Secondary Outcome Measures
Name Time Method Differences of cosmetic outcomes between VitD-AFL-PDT and AFL-PDT The overall cosmetic outcome was assessed 12 months after treatment Cosmetic outcomes were graded as excellent (slight redness or pigmentation change), good (moderate redness or pigmentation change), fair (slight-to-moderate scarring, atrophy, or induration), or poor (extensive scarring, atrophy, or induration)
Difference of adverse events (erythema, post-inflammatory hyperpigmentation, edema, itching, oozing, bleeding) rates between VitD-AFL-PDT and AFL-PDT Within 12 months after each treatment Adverse events reported by the patient were noted at each follow-up visit, including severity, duration and need for additional therapy. All events due to PDT were described as phototoxic reactions (i.e., erythema, post-inflammatory hyperpigmentation, oedema, itching, oozing, bleeding and so forth).
Trial Locations
- Locations (1)
Dong-A University
🇰🇷Busan, Seo-gu, Korea, Republic of, 602-715, Korea, Republic of