Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- - Improvement of the PRO score of the marker lesion at D57 (LC-OCT) and/or clearance in LC-OCT of marker lesion at D57
研究概览
简要总结
The aim of this study is to observe the influence of tirbanibulin on proliferation patterns of actinic keratoses (efficacy on proliferation score according to Schmitz et al.). For this purpose, tirbanibulin is applied in-label, proliferation is measured by LC-OCT at different time points and dermatohistopathology is performed (optionally) at the end. Local skin reactions to the product will also be recorded (tolerability).
详细描述
Actinic keratoses (AK) are premalignant skin changes of a cutaneous squamous cell carcinoma (SCC), which are often triggered by UV exposure. Clinically, they appear as small, rough, reddish, sandpaper-like patches, occasionally also as hyperkeratotic lesions. They are one of the most common reasons for dermatological consultations, and their incidence has been steadily increasing in recent years due to changes in leisure habits with increased UV exposure and demographic changes in the population, such as those observed in Germany.
While the mortality rate of squamous cell carcinoma of the skin is low, the persistence and recurrence of AK, which requires frequent treatment, is a challenge for both patients and healthcare systems.
There are numerous treatment options for AK, ranging from surgical and cryosurgical interventions to ablative laser treatments, topical and photodynamic therapies. These treatments can generally be categorized as lesion- or field-oriented.
Some AK show resistance to conventional therapies. This could possibly be due to different proliferation patterns of AK. Schmitz et al. established the PRO score, an instrument that describes the proliferation behavior of AK in a three-stage scale. This histological score is well validated and is increasingly used in histological diagnostics. New imaging techniques such as confocal line-field optical coherence tomography (LC-OCT) enable real-time assessment of histological parameters without the need for biopsies. In LC-OCT it is possible to detect the PRO Score of an AK in a few seconds.
Clinical parameters such as the Olsen grade, on the other hand, record the visible or palpable hyperkeratosis of an AK. However, the significance of hyperkeratosis for the risk of progression of AK to SCC is only of minor importance. Histological diagnostics and LC-OCT therefore make it possible to determine this risk more precisely.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •male, female, diverse patients (> 18yo) who are capable of giving consent
- •female patients are eligible if the patient is not a woman of childbearing potential (WOCBP) or if she is postmenopausal (cessation of menstruation >12 months) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, total hysterectomy)
- •signed informed consent
- •diagnosis of at least 1 non-hypertrophic, non-hyperkeratotic actinic keratosis of the scalp or face with Olsen Grade I and PRO II or III
- •planned treatment of AK with Klisyri® before study start and indepently of the study
- •the study participant is in good general condition for his or her age and does not currently have any active diseases that, in the opinion of the investigator, justify exclusion from the study
排除标准
- •known or documented intolerance to any of the ingredients of Klisyri®
- •any planned AK treatment other than Klisyri® in the treatment area
- •treatment of actinic keratoses in the treatment area within the past 3 Months (e.g. photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy etc.)
- •suspected invasive squamous cell cancer in the treatment area
- •chronic wounds, erosions, pre-existing inflamed or infected skin with disruption of the epidermal barrier in the treatment area
- •suspected non-compliance
- •current or within the last 8 weeks given systemic cancer medication
- •any other topical treatment against actinic keratosis in the treatment area within the past 12 weeks
- •any contraindication according to the Summary of Product Characteristics (SmPC) of Klisyri®
- •any systemic immunosuppressant given within the 8 weeks prior to the study (e.g. systemic prednisolone, azathioprine etc.)
- •locally applied retinoids, steroids, or other prescribed externals in the 4 weeks prior to the start of the study in the treatment area that, in the opinion of the study physician, necessitate exclusion
- •products containing glycolic or alpha-hydroxy acids applied locally in the treatment area in the last 4 weeks
- •chemical peelings in the treatment area in the last 4 weeks
- •simultaneous participation in a clinical trial
- •participation in a clinical study within the last 30 days
- •family members or colleagues of the investigator or the investigational team or the CRO
- •patient is in a position or has a relationship with the investigator that presents a potential conflict of interest
结局指标
主要结局
- Improvement of the PRO score of the marker lesion at D57 (LC-OCT) and/or clearance in LC-OCT of marker lesion at D57
时间窗: 70 days after inclusion (57 days after visit 2)
Measurement will be done by LC-OCT to detect the PRO Score of the actinic keratosis.
assessment of local skin reaction grading scale at V2
时间窗: 14 days after baseline visit
Assessment of the local skin reaction via a 4-point-likert scaled measurement of erythema, scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration
次要结局
- Clinical clearance of marker lesion at visit 2(14 days after baseline visit)
- Clinical clearance of marker lesion at visit 3(70 days after baseline)
- Improvement of PRO Score at V2(14 days after baseline)
- LC-OCT clearance of marker lesion at V2(14 days after baseline)
- Histopathological clearance of marker lesion at V3(70 days after baseline)
研究者
Thomas Dirschka
Clinical Professor
CentroDerm GmbH