A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis
Safety and Efficacy of Escalating Doses of Two LEO 43204 Formulations Applied Once Daily for Two Consecutive Days on Full Face or Approximately 250 cm2 (40 in2) on the Chest in Subjects With Actinic Keratosis
Part 1:
To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days
Part 2:
To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Alberta
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Edmonton、Alberta、加拿大、T5K 1X3
- Stratica Medical Inc.
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British Columbia
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Surrey、British Columbia、加拿大、V3R 6A7
- Guildford Dermatology Specialists
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New Brunswick
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Moncton、New Brunswick、加拿大、E1C 8X3
- Durondel C.P. Inc./Dermatology Clinic
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Ontario
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Barrie、Ontario、加拿大、L4M 6L2
- Ultranova Skincare
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Courtice、Ontario、加拿大、L1E 3C3
- Co-Medica Research Network Inc.
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Hamilton、Ontario、加拿大、L8N 1V6
- Dermatrials Research Incorporated
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London、Ontario、加拿大、N6A 3H7
- The Guenther Dermatology Research Centre
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Markham、Ontario、加拿大、L3P 1A8
- Lynderm Research Inc.
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Peterborough、Ontario、加拿大、K9J 1Z2
- Skin Centre For Dermatology
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Waterloo、Ontario、加拿大、N2J 1C4
- K. Papp Clinical Research
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Windsor、Ontario、加拿大、N8W 1E6
- XLR8 Medical Research
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Quebec
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Quebec City、Quebec、加拿大、G1V 4X7
- Centre de Recherche dermatologique du Quebec Metropolitain
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Arizona
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Phoenix、Arizona、美国、85018
- Omni Dermatology
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California
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Lomita、California、美国、90717
- Torrance Clinical Research Institute Inc.
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San Diego、California、美国、92121
- Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
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Florida
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Ormond Beach、Florida、美国、32174
- Leavitt Medical Associates of Florida
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Tampa、Florida、美国、33612
- Clinical Research Center, Morsani Center for Advanced Healthcare
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Indiana
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Evansville、Indiana、美国、47713
- Research Institute of Deaconess Clinic
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Evansville、Indiana、美国、47714
- Hudson Dermatology, LLC
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Maryland
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Rockville、Maryland、美国、20850
- DermAssociates, PC
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Michigan
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Bay City、Michigan、美国、48706
- Great Lakes Research Group, Inc.
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West Bloomfield、Michigan、美国、48322
- Henry Ford Medical Center, Dept. of Dermatology
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New Jersey
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Verona、New Jersey、美国、07044
- The Dermatology Group, P.C.
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New York
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New York、New York、美国、10029
- Mount Sinai School of Medicine
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Texas
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San Antonio、Texas、美国、78229
- Clinical Trials of Texas, Inc.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial-related procedures.
- Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the face
- Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on either the face or within a contiguous area of approximately 250 cm2 (40 in2) on the chest
- Subject at least 18 years of age.
Female subjects must be of either:
- Non-childbearing potential, i.e., have a confirmed clinical history of sterility (e.g., the subject is without a uterus or have tubal ligation), or,
- Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment.
- Female subjects of childbearing potential must use effective contraception throughout the study.
Exclusion Criteria:
Location of the treatment area within 5 cm (2 inches) of:
- an incompletely healed wound,
- a suspected basal or squamous cell carcinoma.
- Prior treatment with ingenol mebutate gel on the treatment area.
Lesions in the treatment areas that have:
- atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
- recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
- History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum, Rosacea), at the investigator's discretion.
- Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.
- Any other disease or medical condition such as history or presence of cancer, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, or neurological disease or disorder, that, in the opinion of the investigator, makes the subject unsuitable to participate in the trial.
- Any abnormal laboratory or ECG findings that are clinically significant and would impact the safety of the subjects or the interpretation of the study results, as determined by the investigator.
- Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in Prohibited Therapies or Medications.
- Known sensitivity or allergy to any of the ingredients in the LEO 43204.
- Presence of acute sunburn within the treatment areas.
- Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.
- Subjects previously randomised in the trial (Part 1 or 2).
- Female subjects who are breastfeeding.
- In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state).
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:顺序分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Part 1: LEO 43204 Formulation 1
Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
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实验性的:Part 1: LEO 43204 Formulation 2
Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
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实验性的:Part 2: LEO 43204 Formulation 1 Dose X
Double-Blind, Once-Daily, 2-Day Treatment
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实验性的:Part 2: LEO 43204 Formulation 1 Dose Y
Double-Blind, Once-Daily, 2-Day Treatment
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实验性的:Part 2: LEO 43204 Formulation 2 Dose XX
Double-Blind, Once-Daily, 2-Day Treatment
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实验性的:Part 2: LEO 43204 Formulation 2 Dose YY
Double-Blind, Once-Daily, 2-Day Treatment
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安慰剂比较:Part 2: Placebo Formulation 1
Double-Blind, Once-Daily, 2-Day Treatment
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安慰剂比较:Part 2: Placebo Formulation 2
Double-Blind, Once-Daily, 2-Day Treatment
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Part 1: Number of Participants Experiencing a Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)
大体时间:From Day 1 up to and including Day 8
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The number of participants experiencing DLTs are tabulated by treatment group. This was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants(cohorts 1 to 4) or less than 6 out of 18 participants(cohorts 5 and 6) experiencing a DLT DLT was defined as one or more of the following 3 LSRs:
or two or more of the following five LSRs:
The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are given a numeric grade of severity from 0-4. Grade 0 being no presence and 4 being the highest grade of severity. |
From Day 1 up to and including Day 8
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Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Counts (Multiple Imputation)
大体时间:At Week 8
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At Week 8
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Part 2: Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs) (Multiple Imputation)
大体时间:At Week 8
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Complete clearance was defined as a 100% reduction from baseline in AK count.
For treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with complete clearance.
For treatment group 0.018 the table shows the percentage of mean number of participants with complete clearance in observed cases.
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At Week 8
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Part 2: Percentage of Participants With Partial Clearance of AKs (Multiple Imputation)
大体时间:At Week 8
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Partial clearance was defined as at least 75% reduction from baseline in AK count. For treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with partial clearance. For treatment group 0.018 the table shows the percentage of mean number of participants with partial clearance in observed cases. |
At Week 8
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合作者和调查者
赞助
调查人员
- 首席研究员:Gary Goldenberg, MD、Mount Sinai School of Medicine, Dermatology Faculty
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
LEO 43204 Formulation 1的临床试验
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GlaxoSmithKlineLondon School of Hygiene and Tropical Medicine; PATH; Medical Research Council Unit, The Gambia; Department of State for Health and Social Welfare, The Gambia完全的