NCT04552327已完成3 期
Prospective, Three-armed, Randomised, Double-blind Study to Evaluate the Efficacy and Safety of the Treatment of Mild and Moderate Actinic Keratosis With a 5% Potassium Hydroxide Solution (Solcera, Medical Device) Versus Placebo and Investigator-blinded Comparison With 3% Diclofenac Gel (Solaraze, Medicinal Product) (Regulated by the Laws for Both Medical Devices and Medicinal Products)
Infectopharm Arzneimittel GmbH18 个研究点 分布在 1 个国家目标入组 631 人开始时间: 2020年10月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 631
- 试验地点
- 18
- 主要终点
- Treatment success
研究概览
简要总结
The KOHDIAK study is a prospective, three-armed, randomised, double-blind study to evaluate the efficacy and safety of the treatment of mild and moderate actinic keratosis with a 5% potassium hydroxide solution (Solcera, medical device) versus placebo and investigator-blinded comparison with 3% diclofenac gel (Solaraze, medicinal product). It is performed in accordance with both the laws in force for clinical trials with medical devices and those with medicinal products.
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, Investigator)
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
- •Age ≥ 18 years and < 90 years
- •Actinic keratosis grade I (mild) or II (moderate) according to the definition by Olsen with palpable or clinically/dermatoscopically apparent keratosis
- •Either lesions being well accessible/treatable by the patient or presence of a second person to do the daily applications
- •Written informed consent by the patient
排除标准
- •Number of initial lesions to be treated ≥ 6
- •Overall size of the area to be treated > 25 cm2
- •Size (maximum diameter) of single lesion to be treated > 20 mm
- •Lesions in close proximity to the eyes, eyelids, nostrils, mouth or mucosal tissue
- •Need for topical treatment of cancerous area
- •Presence of a relapsing, persistent, indurated, thickened, painful, bleeding, ulcerated and/or rapidly growing lesion
- •Existing skin cancer (all forms of skin cancer incl. basal-cell carcinoma and squamous cell carcinoma) in the area to be treated in this study
- •Dermal injuries, skin infection or exfoliative dermatitis in the area to be treated in this study
- •Other skin diseases in the area to be treated in this study that affect the diagnostic assessment
- •Pharmacological or physical local therapy of actinic keratosis (or application of the active ingredients used in the pharmacological therapy) in the area to be treated in this study during the last 4 weeks
- •Primary or secondary immunodeficiency
- •Treatment with interferons, interferon inducers, immunomodulators or systemic corticosteroids during the last 4 weeks
- •Treatment with oral isotretinoin during the last 6 months
- •Intracranial bleeding in the medical history or generally increased primary bleeding tendency
- •Known intolerance/hypersensitivity to one of the ingredients of the investigational products, especially to diclofenac, parabens or benzyl alcohol as well as to NSAIDs, in particular acetylsalicylic acid
- •Pregnancy and lactation
- •Women of child-bearing potential either wishing to become pregnant or without effective contraception
- •Other serious diseases, which are (according to the investigator's assessment) in conflict with the study participation (i.a. also in view of risk factors for a severe course of a potential COVID-19 disease in case of a SARS-CoV-2 infection)
- •Obvious unreliability or lack of cooperation
- •Known addiction to alcohol, medicinal products or drugs
- •Dependency on the sponsor or an investigator
- •Participation in a clinical trial during the last 30 days
- •Previous participation in the present clinical trial
- •Participation of a family member (in the same household) in the present clinical trial
研究组 & 干预措施
Solcera
Experimental
干预措施: Solcera (Device)
Placebo
Placebo Comparator
干预措施: Placebo (Device)
Solaraze
Active Comparator
干预措施: Solaraze (Drug)
结局指标
主要结局
Treatment success
时间窗: At the control visit at the end of treatment ("EOT", i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60)
Treatment success, defined as complete, dermatoscopically confirmed remission of all initial actinic keratosis (AK) lesions identified at treatment start that have been treated with the investigational product ("Complete Clearance")
次要结局
- Treatment success(At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks))
- Partial clearance(At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks))
- Lesions with relapse(Analysed at the follow-up visit 24 weeks after treatment start for the time period between treatment start and the follow-up visit)
- (Healing) status of AK lesions(At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks))
- Overall number of AK lesions(At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks))
- Reduction of AK lesion number(At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks))
- Clinical response(At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks))
- Efficacy assessment by patient(At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start)
- Mean size of AK lesions(At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks))
- Lesion-based treatment success (without consideration of relapses)(At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks))
- Lesion-based treatment success (with consideration of relapses)(At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks))
- Patients with relapse(Analysed at the follow-up visit 24 weeks after treatment start for the time period between treatment start and the follow-up visit)
- Efficacy assessment by physician(At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start)
- Tolerability assessment by physician(At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start)
- Tolerability assessment by patient(At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start)
- Overall assessment by physician(At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start)
- Overall assessment by patient(At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start)
- Adverse Events, Serious Adverse Events, Adverse Reactions(In the time period between start of treatment and the follow-up visit (24 weeks after treatment start))
- Dropouts(In the time period between start of treatment and the follow-up visit (24 weeks after treatment start))
- Compliance(Analysed for the respective time period of scheduled product application, i.e. Day 0 until Day 60 for Solaraze and 1-3x 28 days (depeding on number of cycles) for Solcera/Placebo)
研究者
研究点 (18)
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