A Split-Face Clinical Trial of Conventional Photodynamic Therapy Versus Daylight Photodynamic Therapy for The Treatment of Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Reduction in acne lesion counts and total acne severity score on both sides of the face
研究概览
简要总结
Photodynamic therapy (PDT) is considered an effective treatment for acne vulgaris. The study aims to determine whether treatment with daylight as an illumination source is as effective as conventional, red light illumination.
15 patients with acne vulgaris received 4 treatment sessions at three-week intervals. First, 5-aminolevulinic acid (ALA) was applied to the entire face. Then the face was divided into two symmetrical contralateral treatment areas: the left was covered with a light-impermeable dressing, while the right face was exposed to sunlight. After 2 hours outdoors, the right side of the face was covered, and the left half was illuminated with red light.
详细描述
Photodynamic therapy (PDT) is considered an effective treatment for acne vulgaris .One of the most important drawbacks of PDT is the pain during illumination.
It has been shown that daylight PDT is an effective treatment for actinic keratosis. In order to examine the efficacy of daylight PDT for acne vulgaris, we used a split-face design: the face was divided into two symmetrical contralateral treatment areas: the left was covered with a light-impermeable dressing, while the right face was exposed to daylight. After 2 hours outdoors, the right side of the face was covered, and the left half was illuminated with red light.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The photographs of the patients were evaluated by two dermatologists blinded to the study protocol.
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a clinical diagnosis of acne vulgaris on the face
- •Acne lesions include inflammatory papules/ pustules/ nodules and cysts , and non-inflammatory open and closed comedones.
- •Acne refractory to conventional therapies
- •Patients who are unable or do not want to take oral isotretinoin
- •Patients who cannot tolerate isotretinoin
排除标准
- •History of oral retinoid use within 12 months of study entry
- •Systemic antibiotics within 6 month of study entry
- •Topical acne treatment within 1 month of study entry
- •Presence of any other skin disease that could interfere with the assessment of the acne, such as folliculitis or rosacea
- •Presence of any other systemic disease that could affect the acne severity by its presence, such as polycystic ovarian syndrome, or by any medication prescribed for the treatment of the systemic diseases (retinoids, antibiotics).
- •Pregnancy or intention to get pregnant
- •lactating woman
- •Porphyria
- •Photosensitive dermatoses
- •Allergy to any component of the photosensitizer compound
- •Personal history of melanoma or dysplastic nevi
- •A beard or other facial hair that might interfere with study assessments;
研究组 & 干预措施
Right: daylight illumination
The right side of the face was treated using daylight PDT
干预措施: 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form (Drug)
Left face: conventional illumination with red light
The left side was treated with conventional PDT.
干预措施: 5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form (Drug)
结局指标
主要结局
Reduction in acne lesion counts and total acne severity score on both sides of the face
时间窗: We measured the difference between the number of lesions in the first visit and the number of lesions in the follow up visit, 12 weeks after the last teatment
Change in the number of inflammatory and non-inflammatory acne lesions
Difference in adverse effects between the two sides
时间窗: After each of the 4 treatment sessions
Difference in pain scores, erythema after each treatment, erosions and pustulosis
次要结局
未报告次要终点