Evaluation of the Restorative Efficacy of the Cosmetic Product "Onco-Repair" vs. Placebo on Grade 2 Hand Foot Syndrome Induced by Targeted Therapies or Conventional Chemotherapy. Randomized, Multicentre, Double Blind, Controlled Study Versus Placebo.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Overall success
研究概览
简要总结
The aim of the study is to assess the restorative efficacy of the cosmetic product "Onco-Repair" vs placebo of the most affected palmer face in subject with grade 2 HFS induced by targeted therapies or conventional chemotherapy.
详细描述
HFS, also known as Palmar-Plantar Erythrodysethesia, is a common adverse event observed in subjects under anti-tumor therapy with conventional chemotherapy or targeted thérapies. The initial symptoms are dysesthesia and tingling in the palms, fingers and soles of feet and erythema, which may progress to burning pain with dryness, cracking, desquamation, ulceration and oedema. Sensory impairment, paresthesia and pruritus have also been reported. Palms of the hands are more frequently affected than soles of the feet, and might even be the only area affected in some subjects.
Although HFS is rarely life-threatening, the skin changes are often painful and debilitating and can impair with the general activities of daily living and quality of life. No standard prevention for HFS has not been established yet.
Onco-Repair is a nourishing and repairing cream specially formulated to treat grade 2 HFS which demonstrate skin tolerance, hypoallergenicity and efficacy through several preclinical and clinical studies on healthy subjects.
Therefore, a randomized, double-blind, placebo-controlled study will be conducted to evaluate efficacy and safety of topical cream 'Onco-Repair' on HFS.
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)
盲法说明
Cosmetic product "Onco-Repair" and placebo will be filled in the tubes with same appearance and smell. The tubes will be marked anonymusioly
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
- •Who suffers from grade 2 HFS
- •Subject under anti-tumor treatment known to cause this toxicity: targeted therapies or conventional chemotherapy: 5-Fluorouracile, Aflibercept, Axitinib, Bévacizumab, Capécitabine, Cediranib, Cytarabine, Dabrafenib, Docétaxel, Doxorubicine, Epirubicine, Pazopanib, Sorafenib, Sunitinib, Trastuzumab, Regorafenib, Vemurafenib and any other anti-tumor treatment that may lead to this toxicity
- •Subject 18 years old and more
- •Subject having been informed, having signed a free, informed and written consent
- •Woman of childbearing age using contraception deemed effective
- •Non-Inclusion Criteria:
- •Pregnant or lactating women
- •Subject having a history of allergic contact dermatitis or irritation to any of the components of the investigational products
- •Subjects with another skin pathology that may interfere with the evaluation of a HFS (at the investigator's discretion)
- •Subject under anti-inflammatory treatment
- •Subject participating in another clinical study during the duration of the study, except in a study assessing one of the molecules listed in the section above
- •Subject who has already been treated for Grade 2 HFS or under other local treatment or cosmetic product
- •Subject refusing to interrupt the application of his/her usual care
- •Subject having a strongly altered general condition and / or non-autonomous subject (Karnofsky index <50%)
- •Subject in linguistic or psychic impossibility to understand and sign informed consent or in the impossibility of submitting to the medical follow-up of the study
- •Subject deprived of liberty by administrative or judicial decision, or under guardianship
排除标准
- 未提供
研究组 & 干预措施
Onco-Repair
Onco-Repair tube of 150 ml
干预措施: Onco-Repair/ Placebo (Other)
Placebo
Placebo tube of 150 ml
干预措施: Onco-Repair/ Placebo (Other)
结局指标
主要结局
Overall success
时间窗: 28 days
A subject is considered to have attained success if he achieves at least one grade improvement in HFS for the most affected palmer face according to the National Cancer Institute CTCATE V5.0 at any time during study period (28 days). The subjects will be defined in success or failure according to the following rules: Success: switch from grade 2 to grade 1 or grade 0 Failure: switch from grade 2 to grade 3 If subjects remain at grade 2 at the end of the study, they will be classified as either success or failure according to the evolution of clinical signs and / or quality of life assessed using the Dermatological Life Quality Index (DLQI) scale from D0 to D28.
次要结局
- Assessment of symptoms(Day 0 (inclusion) , Day 7 and Day 28)
- Cosmetic parameters such as nourishing power of the cream will be assessed at D28 using a standardized diary(28 days)
- Time to onset of grade 1 or 0 will be assessed using time (in days) from study commencement (inclusion, D0) to first occurrence of grade 1 or lower HFS according to the CTCAEV5.0(28 days)
- Clinical parameters such as lesion color(Day 0 (inclusion) , Day 7 and Day 28)
- Assessment of quality of life from D0 to D28 using Dermatology Life Quality Index scale(28 days)
- Cosmetic parameters such as penetration power of the cream will be assessed at D28 using a standardized diary(28 days)
- The overall tolerance will be assessed by the investigator (Subject interrogation). This evaluation will be carried out during visits using the following rating: 1 = Very good tolerance 2 = Good tolerance 3 = Middle tolerance 4 = Poor tolerance(28 days)
- Clinical parameters such as presence of blisters(Day 0 (inclusion) , Day 7 and Day 28)
- Clinical parameters such as fissures/cracks(Day 0 (inclusion) , Day 7 and Day 28)
- Assessment of pain score and prurit at D0, D7 and D28 using a 100 Visual Analogue Scale [Visual analogue scale, 0 (no pain, no prurit) and 100 (worst possible pain or prurit)](Day 0 (inclusion) , Day 7 and Day 28)
- Assessment of the repair quality of skin(Day 0 (inclusion) , Day 7 and Day 28)
- Cosmetic parameters such as soothing power of the cream will be assessed at D28 using a standardized diary(28 days)
- Assessment of compliance(28 days)
- Safety will be will be evaluated in terms of: - the number of subjects presenting during the study period at least : One AE/ One SAE - the total number of AEs during the study period - the total number of SAEs during the study period(28 days)