NCT04875026已完成4 期
Frequency and Intensity of Local Reactions in Patients Treated With 4% 5-FU vs 4% 5-FU Associated With an Emollient Cream: a Randomised, Controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 27
- 主要终点
- Local Skin Reaction (LSR) total score
研究概览
简要总结
Transient local skin reactions with topical Actinic Keratosis treatments such as 5-FluoroUracil (5-FU) often lead to non-adhesion from patients and thus to treatment failure. In regards to 5-FU treatment, these local reactions are related to the pharmacological action of the molecule. The current therapeutic challenge is to reduce the local reactions induced by 5-FU without interfering with its efficacy, in particular by the use of an emollient cream.
The aim of the present study is to investigate how the use of an emollient, namely Dexeryl, could improve the local skin reactions occurring during 4 weeks of a 4% 5-FU treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
This study is investigator-blinded
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
- •Participants are eligible only if all of the following criteria apply:
- •Participant must be more than 18 years old inclusive, at the time of signing the informed consent.
- •Type of Participant and Disease Characteristics
- •Individuals with a clinical diagnosis of actinic keratosis (AK).
- •Individuals harboring 5 or more clinically recognizable (palpable and/or visible to unaided eye) AK lesions of the face, and/or ears and/or scalp. The AK lesions must be clinically typical non hypertrophic and/or nonhyperkeratotic.
- •Subject in good general condition and free of any disease state or condition which, in the investigator's opinion, could impair evaluation of actinic keratosis or could expose the subject to an unacceptable risk by study participation.
- •Male or female. A Female participant is eligible to participate if she is not a woman of childbearing potential (WOCBP), defined as postmenopausal (cessation of menses >12 months) or surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, total hysterectomy).
- •Informed Consent
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Ethical/Legal considerations
- •Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation).
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions
- •With AK lesions within treatment areas which are hyperkeratotic or which are clinically suspected to be squamous cell carcinoma (SCC).
- •With pre-existing local skin reactions with a total score ≥
- •History of hypersensitivity to the ingredients of Tolak® or Dexeryl®.
- •With a known allergy to peanut or soya.
- •Non postmenopausal or non surgically sterile woman considered as WOCBP, pregnant or breastfeeding women.
- •Prior/Concomitant Therapy
- •Under systemic 5-fluorouracil or any systemic cancer treatment within eight weeks prior to the study.
- •Under any other topical AK treatments or therapies (e.g., Cryotherapy or Photodynamic therapy) in the treatment area(s) within eight weeks prior to starting the study.
- •Treated with systemic steroids, immunosuppressants or immunomodulators within four weeks prior to the study.
- •Under prescription retinoids or topical steroids in the treatment area(s) within four weeks prior to the study.
- •With known dihydropyrimidinedehydrogénase (DPD) deficiency or under treatment with brivudine, sorivudine or analogues within 4 weeks prior to starting the study.
- •Treated with glycolic acid products and alpha-hydroxy products in the treatment area(s) within four weeks prior to starting the study.
- •Treated with chemical peeling products in the treatment area(s) within eight weeks prior to starting the study.
- •Prior/Concurrent Clinical Study Experience
- •Is participating in another clinical trial
- •Has participated in another clinical trial within the last 30 days, has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial Other Exclusions
- •Is a family member of the Investigator or any associate, colleague, and employee assisting in the conduct of the study (secretary, nurse, technician,...)
- •Is in a position likely to represent a conflict of interest
- •Has forfeited his / her freedom by administrative or legal award or is under guardianship
研究组 & 干预措施
5-fluorouracil 4% (Tolak)
Other
This group will only apply 5-FU once daily for 4 weeks.
干预措施: 5-fluorouracil 4% (Tolak) (Drug)
5-fluorouracil 4% (Tolak) + Dexeryl
Experimental
This group will apply 5-FU once daily for 4 weeks, and Dexeryl once daily for 8 weeks.
干预措施: 5-fluorouracil 4% (Tolak) (Drug)
5-fluorouracil 4% (Tolak) + Dexeryl
Experimental
This group will apply 5-FU once daily for 4 weeks, and Dexeryl once daily for 8 weeks.
干预措施: Dexeryl (Device)
结局指标
主要结局
Local Skin Reaction (LSR) total score
时间窗: at 4 weeks or Last Observation Carried Forward (LOCF)
Investigator-assessed score: 6 objective items scored from 0-4 (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration) for a minimal score of 0 (best outcome possible), and a maximal score of 24 (worst outcome possible).
次要结局
- Rates of patients with partial clearance rates(at 8 weeks (last follow up))
- Percentage change in number of AK lesions(at 8 weeks (last follow up))
- Treatment satisfaction (acceptability): measured by Treatment Satisfaction Questionnaire for Medication version 9 (TSQM-9)(at 4 weeks (end of treatment) or at Patient Withdrawal)
- Local Skin Reaction (LSR) total score(at 8 weeks (last follow up))
- Subjective signs at each visit(at 8 weeks (last follow up))
- Local reactions according to Common Terminology Criteria for Adverse Event (CTCAE) grade 3 or 4(at 8 weeks (last follow up))
- Drop outs due to Adverse Events (AE) related to local skin reaction(at 2, 4 and 8 weeks (first follow-up))
- Use of rescue treatment(at 8 weeks (last follow up))
- Treatment adherence(at optional visit (when applicable), up to 8 weeks)
- Health-related quality of life measured by actinic keratosis quality of life questionnaire (AKQoL)(at 8 weeks (last follow up))
- Rates of patients with complete and partial clearance rates(at 8 weeks (last follow up))
- Change in number of AK lesions(at 8 weeks (last follow up))
- Local Skin Reaction (LSR) items alone(at 8 weeks (last follow up))
- Adverse Events reported by patients or noticed by investigator(at 2, 4 and 8 weeks (first follow-up))
研究者
研究点 (27)
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