Photodynamic Therapy for Papulopustular Rosacea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules), Erythema, and Telangiectasia of Rosacea as Assessed by the Investigator's Global Assessment (IGA)
研究概览
简要总结
Rosacea is a chronic inflammatory disorder that is characterized by severe flushing (transient erythema), non-transient erythema, papules, pustules, and telangiectasia. Topical therapy is not always effective in treating symptoms of rosacea. Furthermore, rapid recurrence is common following the use of systemic antibiotics, resulting in the chronic use of these medications to control the disease. Although the exact pathogenesis of rosacea is unknown, treatment for this condition has been investigated based on its similarity to acne and photodamaged skin. Case reports have shown promising results in rosacea patients treated with methyl aminolevulinate photodynamic therapy (MAL - PDT). Other than a case report which observed significant improvement of papules, pustules, erythema, and flushing following 5 - aminolevulinic acid photodynamic therapy (ALA-PDT) treatment of a patient with rosacea, the role of ALA-PDT in the treatment of rosacea has not been reported.
We have designed a pilot study investigating the efficacy of ALA-PDT in treating papulopustular rosacea. The objectives of the study are as follows:
Primary objective:
- To evaluate improvement of the inflammatory lesions (papules, pustules, nodules), erythema, and telangiectasia of rosacea as assessed by the Investigator's Global Assessment (IGA).
- To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of rosacea as assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA).
Secondary objectives: 3. To evaluate improvement of rosacea associated erythema as assessed by the Clinical Erythema Assessment (CEA) scale. 4. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of rosacea as measured by a difference in inflammatory lesion count. 5. To evaluate improvement of rosacea as assessed by the Patient Overall Assessment Scale.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-79 years
- •Clinical diagnosis of papulopustular rosacea based on physician evaluation. Only patients with 3-50 papules and/or pustules, and a CEA total score ≥ 5, (See Section 4.1.3) will be enrolled.
- •History of failing at least one conventional treatment for rosacea (metronidazole, sodium sulfacetamide, tetracycline, azelaic acid) or not interested in continuous treatment with these agents.
排除标准
- •< 18 or > 79 years of age
- •Allergy to 5 - aminolevulinic acid (ALA) or any component of the vehicle
- •Use of topical acne or rosacea treatments (on the face) within 2 weeks prior to Visit 1
- •Use of systemic antibiotics within 1 month prior to Visit 1
- •Use of topical retinoids (on the face) within 1 month prior to Visit 1
- •Use of systemic retinoids, including isotretinoin, within 6 months prior to Visit
- •Use of laser or light based rosacea treatments (on the face) within 1 month prior to Visit 1
- •Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within 2 months prior to Visit 1
- •Use of topical corticosteroids (on the face) 1 month prior to Visit 1
- •Use of systemic corticosteroids 3 months prior to Visit 1
- •Known or suspected history of drug or alcohol abuse within the past 6 months as determined by the medical record or patient interview
- •History of adverse reaction to light exposure
- •History of disorder of porphyrin metabolism
- •Scarring or infection in the area being treated
- •Extensive facial hair that would either impair blue light exposure or interfere with lesion evaluation
- •Inability to make study visits or anticipated poor compliance
- •Pregnant females or nursing mothers. Eligible women of reproductive age will be required to have a negative urine pregnancy test at screening. They will also be required to be on at least one reliable form of effective birth control [examples: barrier method (condoms, diaphragm), oral, injectable, implant birth control or abstinence] during the course of this study and 30 days following the last treatment period.
- •Life threatening illness that would interfere with the patient's ability to complete the study
- •Participation in another clinical experimental therapeutic study within 30 days of screening visit
- •Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator, unsuitable for the study.
研究组 & 干预措施
Levulan and Blu-U Light
Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
干预措施: Aminolevulinic acid topical solution 20% (Drug)
Levulan and Blu-U Light
Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
干预措施: Blu-U Light Therapy (Device)
Vehicle and Blu-U Light
Entire face treated with vehicle substance only and Blu-U light
干预措施: Blu-U Light Therapy (Device)
Vehicle Only
Entire face treated with vehicle substance only
干预措施: Placebo vehicle only (Other)
结局指标
主要结局
Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules), Erythema, and Telangiectasia of Rosacea as Assessed by the Investigator's Global Assessment (IGA)
时间窗: 17 weeks
The Investigator's global assessment (IGA) of rosacea is a subjective 7-point, static scoring system. Scores range from 0 to 6: 0 (clear), 1 (minimal), 2 (mild), 3 (mild to moderate), 4 (moderate), 5 (moderate to severe), 6 (severe).
Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA)
时间窗: 17 weeks
The Inflammatory Lesion Investigator's Global Assessment (ILIGA) is a subjective 5-point measure of the overall disease severity. Scores range from 0 to 4: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe).
次要结局
- Evaluate Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Measured by a Difference in Inflammatory Lesion Count (ILC)(17 weeks)
- Evaluate Improvement of Rosacea as Assessed by the Patient Overall Assessment (POA) Scale(17 weeks)
- Evaluate Improvement of Rosacea Associated Erythema as Assessed by the Clinical Erythema Assessment (CEA) Scale(17 weeks)