A double-blind, randomised and placebo-controlled clinical trial of the safety and efficacy of 3SKIN Sunscreen (SPF50+ with 5-ALA and Vit D3) to reduce the severity and prevent the progression of actinic keratosis in patients with sun-damaged skin, and in healthy subjects

3SKIN AS0 个研究点目标入组 80 人开始时间: 2024年9月16日最近更新: 2024年9月30日

适应症

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 80
主要终点: All measured at the start and end of the study/Visit 1 and Visit 2:1. Actinic keratosis (AK) severity clinically assessed, as per Olsen grading system: 0-3, at baseline and after 3 months +-2 weeks2. AK severity measured using the modified actinic keratosis and severity index (mAKASI) score (0-10.8) at baseline and after 3 months +-2 weeks3. Total (AK) lesion count (TLC) clinically measured at baseline and after 3 months +-2 weeks4. Dermatoscopic grade of AK, as per Zalaudek (2014), measured at baseline and after 3 months +-2 weeks

研究概览入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•Clinical (visual inspection and palpation) diagnosis of sun-damaged skin of the face with clinically typical, visible, and distinct facial AK lesion(s); Olsen global lesion scale grade 1-
•In the judgement of the Investigator are in good general health based on medical history
•Both genders; males and females
•Aged 18-75 yearsHealthy volunteers:
•Both genders; males and females
•Aged 18-75 years

排除标准

•Current, active skin cancer on the face; melanoma or non-melanoma (e.g. basal cell carcinoma (BCC), squamous cell carcinoma (SCC), Bowen’s disease)
•History of photosensitivity
•Known hypersensitivity or allergy to any of the substances under study
•Use of any photosensitising drugs
•Immunocompromised or immunosuppressed subjects for any idiopathic, disease-specific or therapeutic reasons
•Use of any systemic or topical immunosuppressive treatment (e.g. corticosteroids, systemic retinoids, chemotherapy)
•Any topical treatment of sun-damaged skin or AK on the face (incl. medication, cryotherapy, curettage, photodynamic therapy, UV therapy, excision surgery, chemical peeling (e.g. retinol or other acids) in the 28 days prior to randomisation
•Open wounds on the face
•Concurrent use of any vitamin D3 supplement during the trial
•Participation in any trial with an investigational device or drug in the last 28 days (or 5x half-life of an investigational medicinal product; whichever is the longest) prior to randomisation
•Known pregnancy or nursing mothers
•Any clinically unstable medical conditions (e.g. recent diagnosis of a concomitant disease), at the discretion of the Investigator
•Expected poor protocol compliance or any mental or psychiatric co-morbidities that may interfere with the study procedures or assessments in the opinion of the Investigator
•Prior participation in this study

结局指标

主要结局

All measured at the start and end of the study/Visit 1 and Visit 2:1. Actinic keratosis (AK) severity clinically assessed, as per Olsen grading system: 0-3, at baseline and after 3 months +-2 weeks2. AK severity measured using the modified actinic keratosis and severity index (mAKASI) score (0-10.8) at baseline and after 3 months +-2 weeks3. Total (AK) lesion count (TLC) clinically measured at baseline and after 3 months +-2 weeks4. Dermatoscopic grade of AK, as per Zalaudek (2014), measured at baseline and after 3 months +-2 weeks

次要结局

未报告次要终点

研究者

发起方

3SKIN AS

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