Comparative Intraindividual Study, About the Efficacy and Safety of Treatment of Actinic Keratoses With Photodynamic Therapy Between Acid Methyl Aminolevulinate Cream and Aminolevulinic Gel
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparison of MAL with the new BF -200 ALA photosensitizer in actinic keratosis. The Immediate and Delayed Local Reaction and Tolerance will be measured to compare MAL and ALA.
研究概览
简要总结
Photodynamic therapy technique (PDT) is a conventional technique which is performed applying the product under occlusion lesions, let it incubate for 3 hours and then exposed skin to a light source, usually red.
The conclusions of efficacy, tolerance and satisfaction that today are known about PDT with MAL, but not with ALA, which is a new photosensitizer indicated for Actinic Keratoses. The pharmaceutical form of ALA is a gel, which gives a hypothetical better penetration and consequently it is more effectively.
详细描述
Intraindividual comparative study, to evaluate efficacy and safety of the treatment of actinic keratosis with photodynamic therapy between methyl aminolevulinate cream (MAL) and aminolevulinic acid nanosoma gel (ALA).
MAL cream: is an antineoplastic agent used as a photosensitizer for photodynamic therapy (PDT). The mode of action of methyl aminolevulinate in PDT was shown in the pharmacodynamic (PD) studies. In the target cells,methyl aminolevulinate was converted to photoactive porphyrins, including protoporphyrinIX (PpIX), which are the active photosensitizers. Upon light activation, the photosensitizers give rise to the production of cytotoxic singlet oxygen species which destroy the target cells.
ALA gel: Following topical application of 5-aminolaevulinic acid, the substance is metabolized to protoporphyrin IX, a photoactive compound which accumulates intracellularly in the treated actinic keratosis lesions. Protoporphyrin IX is activated by illumination with red light of a suitable wavelength and energy. In the presence of oxygen, reactive oxygen species are formed. The latter causes damage of cellular components and eventually destroys the target cells.
Photodynamic therapy technique (PDT) is a conventional technique which is performed applying the product under occlusion lesions, let it incubate for 3 hours and then exposed skin to a light source, usually red.
The conclusions of efficacy, tolerance and satisfaction that today are known about PDT with MAL, but not with ALA, which is a new photosensitizer indicated for QA. The pharmaceutical form of ALA is a gel, which gives a hypothetical better penetration and consequently it is more effectively.
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 (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
- •1 Patient over 18 years old and capable of giving informed consent.
- •Provide at least 5 QA in two symmetrical areas of the face or scalp.
- •Accept the abandonment of sun creams and other creams (retinoic hydroxy acids, emollients, Topical Antibiotics ) in the treatment area during the time of the study.
- •Accept that it will postpone the treatment of other actinic keratosis close to treatment area.
- •Accept to go to scheduled visits. They should answer a questionnaire about epidemiology, history and treatment satisfaction. They will accept a photo of treatment area at each visit.
排除标准
- •Have any dermatological disease on the treatment zone or around it.
- •Patients who have previously been treated with therapy Photodynamic in targeted areas.
- •Patients with alcohol or drug dependence.
- •Patients who are currently participating in other studies.
- •Patients who have received any of the following medications at a time less than the indicated:
- •Systemic chemotherapy in the last 6 months.
- •Retinoids systemic , interferon , immunomodulatory or immunosuppressive , cytotoxic including agents , corticosteroids systemic , in the last month .
- •Ultraviolet A light, Ultraviolet B light, ablative laser, dermabrasion, chemical peels, in the last 6 months.
- •Topical retinoids , topical 5 -fluorouracil in the last month.
- •Cryotherapy , surgical excision, curettage, topical corticosteroids in the last month.
研究组 & 干预措施
METHYLAMINOLEVULINATE HYDROCHLORIDE
METHYLAMINOLEVULINATE HYDROCHLORIDE (MAL)cream 160mg/g. Intervention: Just one application of the product in the actinic keratosis lesions before the photodynamic therapy
干预措施: METHYLAMINOLEVULINATE HYDROCHLORIDE (Drug)
METHYLAMINOLEVULINATE HYDROCHLORIDE
METHYLAMINOLEVULINATE HYDROCHLORIDE (MAL)cream 160mg/g. Intervention: Just one application of the product in the actinic keratosis lesions before the photodynamic therapy
干预措施: AMINOLEVULINIC ACID HYDROCHLORIDE (Drug)
AMINOLEVULINIC ACID HYDROCHLORIDE
AMINOLEVULINIC ACID HYDROCHLORIDE (ALA) gel 78mg/g. Intervention: Just one application of the product in the actinic keratosis lesions before the photodynamic therapy
干预措施: METHYLAMINOLEVULINATE HYDROCHLORIDE (Drug)
AMINOLEVULINIC ACID HYDROCHLORIDE
AMINOLEVULINIC ACID HYDROCHLORIDE (ALA) gel 78mg/g. Intervention: Just one application of the product in the actinic keratosis lesions before the photodynamic therapy
干预措施: AMINOLEVULINIC ACID HYDROCHLORIDE (Drug)
结局指标
主要结局
Comparison of MAL with the new BF -200 ALA photosensitizer in actinic keratosis. The Immediate and Delayed Local Reaction and Tolerance will be measured to compare MAL and ALA.
时间窗: 1 month
The main objective of this study is to compare the MAL with the new BF -200 ALA photosensitizer in terms of local reaction and tolerance for the treatment of actinic keratosis . First of all, the immediate local reaction to the lighting may include a greater or less erythema, inflammation and edema. It is scored on a scale of 0-10 where 0 is normal skin without local reaction and 10 is a maximum local reaction. The delayed local reaction is defined by the presence in different degrees of erythema, swelling, edema, pustules and scabs. They are also marked from 0 to 10 where 0 is normal skin without reaction and 10 for local maximum reaction. On the other hand, tolerance will be measured by the number, frequency and grade of reported adverse events in patients.
次要结局
- Comparison of the clinical response measured by the efficacy and characteristics of fluorescence emission between the two photosensitizers. Partial and total response will be defined with ≥75% (partial response) and 100% (complete response.)(1 month)