Clinical trial NCT03612011: Efficacy of the Cosmetic Product "Onco-Repair" on Grade 2 Hand Foot Syndrome
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Grade 2 Hand-foot Syndrom
Keywords: Hand Foot Syndrome Grade 2
Common Terminology Criteria for Adverse Events (CTCAE)
Oncology
Repair Cream
Cutaneous events
Palmar-plantar erythrodysesthesia syndrome
Targeted Therapies or Conventional Chemotherapy
Lead sponsor: Quanta Medical
Sponsor class: INDUSTRY
Collaborators: name: NAOS Institute of Life Science
First posted: 2018-08-02
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase III multicenter, double blind, superiority, prospective, randomised controlled study Subjects will be randomized to receive either cosmetic product "Onco-Repair" or placebo in a 1:1 ratio
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Overall success
timeFrame: 28 days
Secondary outcomes:
measure: 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
timeFrame: 28 days
measure: Clinical parameters such as lesion color
timeFrame: Day 0 (inclusion) , Day 7 and Day 28
measure: Clinical parameters such as presence of blisters
timeFrame: Day 0 (inclusion) , Day 7 and Day 28
measure: Clinical parameters such as fissures/cracks
timeFrame: Day 0 (inclusion) , Day 7 and Day 28
measure: Assessment of quality of life from D0 to D28 using Dermatology Life Quality Index scale
timeFrame: 28 days
measure: Assessment of symptoms
timeFrame: Day 0 (inclusion) , Day 7 and Day 28
measure: 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)]
timeFrame: Day 0 (inclusion) , Day 7 and Day 28
measure: Assessment of the repair quality of skin
timeFrame: Day 0 (inclusion) , Day 7 and Day 28
measure: Cosmetic parameters such as nourishing power of the cream will be assessed at D28 using a standardized diary
timeFrame: 28 days
measure: Cosmetic parameters such as soothing power of the cream will be assessed at D28 using a standardized diary
timeFrame: 28 days
measure: Cosmetic parameters such as penetration power of the cream will be assessed at D28 using a standardized diary
timeFrame: 28 days
measure: Assessment of compliance
timeFrame: 28 days
measure: 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
timeFrame: 28 days
measure: 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
timeFrame: 28 days
Other outcomes:
Locations:
city: Rueil-Malmaison
country: France
facility: Quanta Medical
Study officials:
References:
citation: Lipworth AD, Robert C, Zhu AX. Hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia): focus on sorafenib and sunitinib. Oncology. 2009;77(5):257-71. doi: 10.1159/000258880. Epub 2009 Nov 16.
citation: Zhang RX, Wu XJ, Lu SX, Pan ZZ, Wan DS, Chen G. The effect of COX-2 inhibitor on capecitabine-induced hand-foot syndrome in patients with stage II/III colorectal cancer: a phase II randomized prospective study. J Cancer Res Clin Oncol. 2011 Jun;137(6):953-7. doi: 10.1007/s00432-010-0958-9. Epub 2010 Nov 27.