NCT02600598已完成1 期
Biological Effects of LEO 43204 in Actinic Keratosis Assessed by Histopathology
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of CD3+ T lymphocytes assessed by immunohistochemistry in biopsies from AK lesions 56 days after first treatment.
研究概览
简要总结
This is a Phase I, single-centre, open label, within-subject comparison trial to explore the biological effects of LEO 43204 Gel, 0.037%, applied once daily for 3 consecutive days in patients with actinic keratosis on the upper extremity. The treatment area for each patient will be as defined as a contiguous area of 250 cm2 of skin on the upper extremity (including the dorsum manus) that contains a minimum of 5 AK lesions. Additionally there must be at least one AK lesion located in a non-treated area on the contralateral arm. All eligible subjects will receive LEO 43204 Gel, 0.037%, on the treatment area on Days 1, 2 and 3. Study medication application will be (sub)investigator applied. A total of 30 patients will be enrolled into this study (n=15 in each of the two groups). Patients will be divided into two groups with different biopsy schedules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Signed and dated informed consent has been obtained.
- •Subjects with at least 5 non-keratotic, clinically typical, visible and discrete AK lesions within a contiguous 250 cm2 area (AK Treatment Area) on the upper extremity,
- •Subjects with one additional AK lesion located on the contralateral arm.
- •Subjects with an area of normal skin in close proximity to the AK Treatment Area or on the contralateral arm.
- •Male and female subjects, 18 years or older.
- •Agreement from the patient to allow photographs of the selected treatment area to be taken and used as part of the study data package
- •Ability to follow study instructions and likely to complete all study requirements
- •Female Subjects must be of either
- •non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal litigation) or,
- •child-bearing potential* provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.
- •Female subjects are considered of child-bearing potential unless they have had a hysterectomy or have undergone tubal litigation or have been post-menopausal for at least one year prior to first visit.
- •Female subjects of child-bearing potential must be willing to use effective contraception at trial entry and until completion.
- •Effective contraception is defined as follows:
- •Abstinence (when this is in line with the preferred and usual life style of the subject).
- •Vasectomised partner (given that the subject is monogamous).
- •An intrauterine device.
- •Double barrier method defined as two distinct methods (two actual barrier methods).
- •Hormonal contraceptive (oral hormonal birth control, oestrogenic vaginal ring, percutaneous contraceptive patches, implants and injectables) for at least one menstrual cycle prior to enrolment.
排除标准
- •Prior treatment with ingenol mebutate gel in the treatment area within the last 12 months.
- •Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme (presently LP0084-68, LP0084-1013, LP0084-1014, LP0084-1015, LP0084-1148, LP0084-1077, LP0084-1193, LP0084-1194, LP0084-1195, LP0084-1196).
- •Location of the selected treatment area within 5 cm of an incompletely healed wound or infected area of the skin (excl. study related biopsies) or within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.
- •History or evidence of skin conditions other than the study indication that would interfere with the histologically- or biomarker evaluation of the study medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum).
- •Treatment area lesions that have an atypical clinical appearance (e.g. hypertrophic, hyperkeratotic, recalcitrant disease [had cryosurgery on two previous occasions] and/or cutaneous horns).
- •Known sensitivity or allergy to any of the ingredients of LEO 43204 Gel (e.g. citric acid)
- •Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety during the course of the study, as determined by Investigator clinical judgment.
- •Anticipated need for in-patient hospitalisation or in-patient surgery during the study period. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in the Prohibited Therapies or Medications (listed below).
- •Anticipated excessive or prolonged exposure to ultraviolet light (e.g. sunlight) or use of tanning beds for the duration of the study
- •Current participation in any other interventional clinical trial
- •Subjects who have received treatment with any non-marketed drug product (i.e. an agent which has not yet been made available for clinical use following registration) within the last two months.
- •Subjects known to be infected with Human Immunodeficiency Virus (HIV).
- •Subject known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state).
- •Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial, or are breast feeding.
- •Females of child-bearing potential with positive pregnancy test at [screening or visit 1].
- •Previous enrolment in this clinical trial. Prohibited Therapies and/or Medications: within 2 weeks prior to the Screening visit
- •Cosmetic or therapeutic procedures (e.g. use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 cm of the selected treatment areas and within 2 cm of the selected AK lesion outside the treatment area
- •Use of acid-containing therapeutic products (e.g. salicylic acid or fruit acids, such as alpha and beta hydroxy acids and glycolic acids), topical retinoids or light chemical peels: within 2 cm of the selected treatment areas and within 2 cm of the selected AK lesion outside the treatment area
- •Use of topical salves (non-medicated/non-irritant lotion/cream are acceptable) or topical steroids: within 2 cm of the selected treatment areas and within 2 cm of the selected AK lesion outside the treatment area; artificial tanners: within 5 cm of the selected treatment areas and within 5 cm of the selected AK lesion outside the treatment area Prohibited Therapies and/or Medications: within 4 weeks prior to the Screening visit
- •Treatment with immunomodulators (e.g. azathioprine), cytotoxic drugs (e.g. cyclophosphamide, vinblastine, chlorambucil, methotrexate, podophyllin, camptothecin) or interferon/interferon inducers.
- •Treatment with systemic medications that suppress the immune system (e.g. cyclosporine, prednisone, methotrexate, infliximab).
- •Treatment/therapy with UVB
- •Prohibited Therapies and/or Medications: within 8 weeks prior to the Screening visit
- •Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of the selected treatment areas and within 2 cm of the selected AK lesion outside the treatment area Prohibited Therapies and/or Medications: within 6 months prior to the Screening visit
- •Use of systemic retinoids (e.g. isotretinoin, acitretin, bexarotene)
研究组 & 干预措施
LEO 43204 Group A
Experimental
Group A - Experimental LEO 43204, applied once daily for 3 consecutive days in patients with actinic keratosis
干预措施: LEO 43204 Gel, 0.037% (Drug)
LEO 43204 Group B
Experimental
Group B - Experimental LEO 43204, applied once daily for 3 consecutive days in patients with actinic keratosis
干预措施: LEO 43204 Gel, 0.037% (Drug)
结局指标
主要结局
Number of CD3+ T lymphocytes assessed by immunohistochemistry in biopsies from AK lesions 56 days after first treatment.
时间窗: 56 days
次要结局
- Expression of inflammatory and skin matrix modulation markers assessed by RNA expression and immunohistochemistry(8 weeks)
- Number of infiltrating cells assessed by immunohistochemical staining(8 weeks)
- Expression of cleaved caspase-3 (apoptosis) assessed by immunohistochemical staining as area of section with positive staining(8 weeks)
- Expression of ICAM-1 (marker of vascular endothelium activation) assessed by immunohistochemical staining as area of section with positive staining.(8 weeks)
- Expression of Ki-67 and K16 (markers of cell proliferation and differentiation) assessed by immunohistochemical staining as area of section with positive staining.(8 weeks)
- Necrosis of the epidermis and dermis in haematoxylin & eosin-stained sections (scored on 0-3 scale).(8 weeks)
- Number of p53 gene mutations determined by DNA sequencing in normal and AK skin and blood at baseline and in a treated AK lesion at Week 8.(8 weeks)
研究者
研究点 (2)
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