Clinical Effect of Photodynamic Treatment When Treating Actinic Keratoses With Different Light Doses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Clinically cleared actinic keratosis with histological evaluation when clinically suspicious for relapse
研究概览
简要总结
Aim of the study: To evaluate clinical effectiveness of two different light doses when treating actinic keratoses with photodynamic therapy with 20% 5-aminolevulinic acid.
详细描述
To determine and compare clinical and histological effectiveness of different (70 J/cm2 ir 100 J/cm2) light doses when treating actinic keratoses with photodynamic therapy.
To determine pain intensity during photodynamic therapy with visual analogue scale and factors influencing pain during the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject older than 50 years.
- •Subject has to read Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedure.
- •AK with the largest diameter ≤3 cm (measuring the longest axis).
- •2 or more AK with symmetrical distribution on the face or scalp.
- •Clinically and histologically confirmed AK of grade I or II.
- •Subject must be willing and capable of cooperating to the extent and degree required by the protocol.
- •Patient is not the subject of the administrative or legal judicial proceeding.
- •Subject has social health security required by laws of health care institutions.
排除标准
- •Patients with more than 5 AK in the planned treatment area.
- •A recurrent AK: AK that has been previously treated in the study area.
- •Very hyperkeratotic, grade 3 (on a 0-3 scale) AK lesions among the target lesions.
- •AK located on the nose.
- •Other skin lesions (diseases) in the tumor study area.
- •Subject with known hereditary basal cell carcinoma syndromes (Gorlin-Goltz, Basex-Dupre-Christol et al.).
- •Subject with a history of cutaneous photosensitization or porphyria or Xeroderma pigmentosum, hypersensitivity to porphyrins, or photodermatosis.
- •Subject who had received photosensitizing drugs 30 days before study start.
- •Subjects who had received immunomodulatory or immunosuppressive therapies, including systemic and topical steroids, imiquimod or solaraze, interferon and acitretin 6 months prior to study treatment initiation.
- •Subject who had participated in another investigational drug or device research study within 30 days of enrolment.
- •Subject had received in the study area laser resurfacing, chemical peels, topical application fluorouracil or other drugs for the treatment of AKs within 2 months before study entry.
- •Subject with known hypersensitivity to 5-aminolevulinc acid, a similar compound or excipients of the cream.
- •Subject with known status after organ transplantation.
研究组 & 干预措施
Group I
Patients with actinic keratosis (AK) on the left and right sides of face/scalp region treated with photodynamic therapy using 20% 5-aminolevulinic acid.
干预措施: Photodynamic therapy with light dose of 70 J/cm2 using a broad-band red light source (Device)
Group II
Patients with actinic keratosis (AK) on the left and right sides of the face/scalp region treated with photodynamic therapy using 20% 5-aminolevulinic acid.
干预措施: Photodynamic therapy with 100J/cm2 light dose using a broad-band red light source (Procedure)
结局指标
主要结局
Clinically cleared actinic keratosis with histological evaluation when clinically suspicious for relapse
时间窗: 3 months
All treated actinic keratoses evaluated by two investigators for clinical/histological relapse at months 1, 3, 6, 12, 24 after treatment
次要结局
- Pain during the treatment(2 years)
研究者
Evelina Buinauskaite
Principal investigator
Lithuanian University of Health Sciences