Pretreatment With Ablative Fractional Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Complete Clearance (%) of Actinic Keratoses (AKs)
研究概览
简要总结
Comparison of treatment efficacy and safety of pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic therapy with methyl aminolevulinate for actinic keratoses
详细描述
For each study participant, two test areas (A and B) are demarcated in the same anatomical region, with each area containing no less than 5 actinic keratoses (AKs). Test areas are randomized to receive skin pretreatment of EITHER ablative fractional laser OR microdermabrasion prior to photodynamic therapy using methyl aminolevulinate.
Efficacy, local skin reactions and safety of both test areas are evaluated over a 12-15 week follow up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with two skin areas of at least 50 cm2 with a minimum of 5 actinic keratoses (AKs) grade I-III, chronically sun damaged "field" changes in one of the following anatomical regions: face, scalp, upper chest.
- •Patients who have given written informed consent and are believed to be capable of following the study protocol.
- •Fertile women must have a negative pregnancy test (urine-hCG) at the time of inclusion and use anti-contraception (oral contraceptives, intrauterine device, gestagen depot injection, subdermal implantation, vaginal ring, transdermal depot bandage or sterilisation) during the study.
排除标准
- •Patients that have within the last month received local treatment in the test areas.
- •Pregnant or nursing patients.
- •Patients with porphyria
- •Patients with skin cancer, keratoacanthoma, or other infiltrating tumors within the test areas.
- •Patients with a tendency to develop hypertrophic scars or keloids.
- •Patients with a known allergy to Metvix cream
- •Patients that are believe unlikely to follow the study protocol.
结局指标
主要结局
Complete Clearance (%) of Actinic Keratoses (AKs)
时间窗: 12-15 weeks post-treatment
Percentage clearance of baseline actinic keratoses (AKs), determined by the ratio of AK lesions that are clinically resolved 12-15 weeks after treatment compared to the AK number at baseline.
次要结局
- New Actinic Keratoses (AKs)(12-15 weeks post-treatment)
- Treatment-related Pain(during treatment (day 0))
- Patient-reported Cosmesis(12-15 weeks post-treatment)
- Patient Pretreatment Preference(12-15 weeks post-treatment)
- Treatment-related Side Effects(up to 12-15 weeks post-treatment)
- Severity of Local Skin Reactions (LSRs)(Day 3-6 post treatment)
- Degree of Sun Damage(12-15 weeks post-treatment)
- Investigator-reported Cosmesis (Clinical Evaluation)(12-15 weeks post-treatment)
研究者
Merete Haedersdal
Professor and Senior Physician
Bispebjerg Hospital