Photodynamic Therapy With Topical Application of a Zn(II) Phthalocyanine (RLP068/Cl) and Red Light for the Treatment of Moderate-to-severe Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Change in Global Acne Grading System (GAGS) score from baseline
研究概览
简要总结
This pilot clinical study will evaluate the safety, tolerability, and effectiveness of a novel photodynamic therapy (PDT) for moderate-to-severe acne vulgaris. PDT combines a topical photosensitizing gel with red light to treat acne lesions. The gel to be used in this study, called RLP068/Cl (a zinc phthalocyanine compound), has demonstrated antimicrobial, anti-inflammatory, and sebosuppressive effects in laboratory studies.
A total of 10 patients with moderate-to-severe acne on the face will be enrolled. RLP068/Cl 0.3% gel will be applied topically for 30 minutes under occlusion, followed by 8 minutes of red LED light exposure. Treatments will be performed twice weekly, with the total number of sessions individualized based on clinical response.
Acne severity will be assessed using the Global Acne Grading System (GAGS). Pain levels will be recorded after each session using a visual scale, and patient satisfaction will be evaluated at the end of the treatment cycle.
The goal of the study is to determine whether RLP068/Cl-PDT is a safe, well-tolerated, and effective non-antibiotic treatment option for patients with moderate-to-severe acne vulgaris who may not respond to or tolerate conventional therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged ≥16 years.
- •Diagnosis of moderate-to-severe acne vulgaris (comedonal, papulopustular, or cystic), with facial lesions symmetrically distributed.
- •Washout period of at least 6 months from prior oral acne treatments.
- •Washout period of at least 2 months from prior topical acne treatments.
- •Ability to understand the study procedures and provide written informed consent.
排除标准
- •Use of systemic or topical photosensitizing medications.
- •Known photosensitivity disorders.
- •Pregnancy or breastfeeding.
- •Participation in another interventional clinical study within the past 3 months.
- •Any dermatological condition of the face that may interfere with treatment assessment (e.g., eczema, rosacea).
- •Any serious uncontrolled medical condition deemed by the investigator to pose a risk to the participant or interfere with study results.
研究组 & 干预措施
RLP068/Cl Photodynamic Therapy
干预措施: Zn(II)-phthalocyanine gel (Drug)
结局指标
主要结局
Change in Global Acne Grading System (GAGS) score from baseline
时间窗: End of treatment, expected within 4 to 6 weeks from baseline
The Global Acne Grading System is a validated acne severity assessment tool based on lesion type and anatomical location. In this study, the facial Global Acne Grading System score will be calculated by assessing the forehead, right cheek, left cheek, nose, and chin. The total facial score ranges from 0 to 32, with higher scores indicating more severe acne. The primary outcome will be the change in total facial Global Acne Grading System score from baseline to the end of treatment; a reduction in score indicates clinical improvement.
Change in Global Acne Grading System (GAGS) score from baseline
时间窗: End of treatment (EOT), expected within 4 to 6 weeks from baseline
The Global Acne Grading System (GAGS) is a validated tool that assesses acne severity based on lesion type and anatomical location. The outcome will be measured as the change in total GAGS score from baseline to the end of treatment.
次要结局
未报告次要终点
研究者
Stefano Bighetti
MD
Università degli Studi di Brescia