Prospective, Randomized, Controlled, Multicenter, Two-armed, Study Comparing Daylight Photodynamic Therapy Using MAL With Cryosurgery for the Treatment and Prophylaxis of Actinic Keratoses in Photodamaged Skin of the Face
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 4
- 主要终点
- The cumulative number of observed AKs at time points 2 to 6 (3 months after the first treatment to 24 months after the first treatment).
研究概览
简要总结
This study is a multicenter study investigating the clinical efficacy of repetitive daylight-PDT with MAL (Methylaminolevulinate) compared to cryosurgery in regard to prophylaxis and treatment of AKs (actinic keratoses) in the face. Patients will be randomly allocated to treatment groups. 5 PDT (photodynamic therapy) treatment sessions (visits 1-5) will be performed within 18 months. In the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5.
In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion preparation of AKs (removal of crusts) will be performed and MAL will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours. In the control group, cryosurgery will be performed using liquid nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by documenting all existing and newly appearing AKs in the face.
详细描述
This study is a multicenter study investigating the clinical efficacy of repetitive daylight-PDT with MAL compared to cryosurgery in regard to prophylaxis and treatment of AKs in the face. Patients will be randomly allocated to treatment groups. 5 PDT treatment sessions (visits 1-5) will be performed within 18 months. In the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5.
Before application of the photosensitizer, an organic sunscreen (Actinica® lotion, LSF 50+) without mineral filters will be applied In the entire face.
After an absorption time of approximately 15 minutes and before applying MAL (Metvix®), the surface of the AK lesions will be prepared gently with a curette or a scalpel to remove scales and crusts and roughen the surface of the AK-lesions. This is to facilitate penetration of the cream and light to the AK lesions.
After lesion preparation, MAL (Metvix®) will be uniformly applied on the whole face in a thin layer.
Within 30 min after MAL application the patients go outside and expose themselves for 2 hours to daylight. Daylight-PDT can be performed from March until October, during non-rainy weather with an outdoor temperature of at least 10° Celsius. Daylight exposure must start at least 3 hours before sunset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent has been signed prior to or at Screening Visit
- •Male and female patients with Fitzpatrick skin type I-IV
- •Age > 40 years
- •Negative pregnancy test in women of childbearing age
- •Women in child-bearing age using highly efficient contraceptive methods (<1% failure rate per year)
- •Clinical diagnosis of actinic keratosis (AK)
- •A minimum of five non-hyperkeratotic, non-pigmented AK lesions in the face.
- •Glogau Photodamage Classification Type II (moderate) - IV (severe)
排除标准
- •Diagnosis of porphyria
- •Hyperkeratotic or pigmented AK in the face
- •Malignant skin tumors in the face or on the capillitium, requiring treatment
- •Patients with clinically relevant suppression of the immune system (e.g. drug induced, infection) or organ transplant patients
- •Pregnancy or lactation
- •Planned aesthetic treatments in the face in the next 24 months (filler, peeling, botulinumtoxin, skin resurfacing)
- •Known intolerance or allergy to MAL or to any other ingredient of Metvix® 160mg/g cream
- •Known intolerance to Actinica® lotion
- •Photosensitivity
- •Suspected lack of compliance (e.g. due to dementia)
- •Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion
- •Concomitant UV-phototherapy
- •Skin diseases that might interfere with response evaluation of study treatment
- •Skin sun sensitivity type V or VI according to Fitzpatrick
- •PDT in the face during 6 months preceding study treatment
- •Non-permitted medication:
- •Topical treatment in the face during 4 weeks preceding study treatment with diclofenac, hydrochinone, peeling, 5-FU, ingenolmebutate, retinoids, podophyllin, azelaic acid, imiquimod or other agents, that could interfere with the evaluation of the efficacy of the study treatment, according to the investigator.
- •Systemic treatment with retinoids
- •Conditions that might interfere with the ability to understand the study and thus give written informed consent
- •Rejuvenating treatments of the face during 3 months preceding study treatment, including filler, botulinumtoxin and IPL
研究组 & 干预措施
Daylight photodynamic therapy (PDT)
One intervention in the daylight photodynamic therapy arm:
Daylight photodynamic therapy using Methylaminolevulinate (MAL) will be performed five times within 18 months (visits 1-5). In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion preparation of AKs (removal of crusts) will be performed and methylaminolevulinate (MAL) will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours.
干预措施: Daylight photodynamic therapy using Methylaminolevulinate (MAL) (Drug)
Cryosurgery
In the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5. In the control group, cryosurgery will be performed using liquid nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by documenting all existing and newly appearing AKs in the face.
干预措施: Cryosurgery (Procedure)
结局指标
主要结局
The cumulative number of observed AKs at time points 2 to 6 (3 months after the first treatment to 24 months after the first treatment).
时间窗: 24 months after the first treatment
Newly occured AK lesions are counted at visit 2, visit 3, visit 4, visit 5 and visit 6. The number of newly occured AK lesions during the study are added up, therefore we included the term "cumulative".
次要结局
- Complete clearance of AKs on lesion basis(This outcome measure is assessed three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment.)
- Complete clearance of AKs on patient basis(This outcome measure is assessed three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment.)
- Photodamage parameters (fine lines, mottled pigmentation, tactile roughness, teleangiectasias, sallowness and global score for photoaging) will be evaluated on a 5-point scale according to Dover et al.(This outcome measure is assessed at day 0 (= the first treatment), three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment.)
- Visual pain score(This outcome measure is assessed at day 0 (= the first treatment), three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment)
- Adverse events(This outcome measure is assessed at day 0 (= the first treatment), three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment)
- Patient satisfaction with cosmetic results(This outcome measure is assessed three months after day 0 and the second treatment and 6 months after the third, fourth and fifth treatment)
- Skin-related quality of life(This outcome measure is assessed at day 0 and 24 months after day 0)
研究者
Professor Dr. Sigrid Karrer
Professor
University Hospital Regensburg