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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Differences of short-term complete response rates between VitD-AFL-PDT and AFL-PDT
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Korean patients aged ≥ 18 years who had biopsy-confirmed Actinic keratosis lesions
排除标准
- •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
研究组 & 干预措施
GroupA (Vit-D pretreated AFL-PDT group )
Group A was treated with topical VitD-assisted AFL-PDT
干预措施: Topical Vitamin D (Calcipotriol) application (Drug)
GroupA (Vit-D pretreated AFL-PDT group )
Group A was treated with topical VitD-assisted AFL-PDT
干预措施: lidocaine/prilocaine (5%) application (Drug)
GroupA (Vit-D pretreated AFL-PDT group )
Group A was treated with topical VitD-assisted AFL-PDT
干预措施: MAL application (Drug)
GroupA (Vit-D pretreated AFL-PDT group )
Group A was treated with topical VitD-assisted AFL-PDT
干预措施: Measurements of the fluorescence intensity (Other)
GroupA (Vit-D pretreated AFL-PDT group )
Group A was treated with topical VitD-assisted AFL-PDT
干预措施: irradiation with red light-emitting diode lamp (Device)
GroupB (Conventional AFL PDT group )
Group B was treated with conventional AFL-PDT
干预措施: Placebo cream application (Drug)
GroupB (Conventional AFL PDT group )
Group B was treated with conventional AFL-PDT
干预措施: lidocaine/prilocaine (5%) application (Drug)
GroupB (Conventional AFL PDT group )
Group B was treated with conventional AFL-PDT
干预措施: MAL application (Drug)
GroupB (Conventional AFL PDT group )
Group B was treated with conventional AFL-PDT
干预措施: Measurements of the fluorescence intensity (Other)
GroupB (Conventional AFL PDT group )
Group B was treated with conventional AFL-PDT
干预措施: irradiation with red light-emitting diode lamp (Device)
结局指标
主要结局
Differences of short-term complete response rates between VitD-AFL-PDT and AFL-PDT
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Differences of cosmetic outcomes between VitD-AFL-PDT and AFL-PDT(The overall cosmetic outcome was assessed 12 months after treatment)
- 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)
研究者
Song Ki-Hoon
Assistant professor and chairman, Department of dermatology Dong-A University, College of medicine
Dong-A University