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| Name | Class |
|---|---|
| NAOS Institute of Life Science | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Onco-Repair | Experimental | Onco-Repair tube of 150 ml |
|
| Placebo | Placebo Comparator | Placebo tube of 150 ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onco-Repair/ Placebo | Other | Cream must be applied twice a day, in the morning and evening, on the hands and feet (palmo-plantar areas and interdigital spaces included) previously cleaned with Atoderm Intensive Foaming Gel, chosen as a standardized hygiene product. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall success | 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. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Time to onset of grade 1 or 0 will be assessed using time (in days) from study | 28 days |
| Clinical parameters such as lesion color |
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Inclusion Criteria:
Non-Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quanta Medical | Rueil-Malmaison | 92500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19923864 | Background | 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. | |
| 21113620 | Background | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D060831 | Hand-Foot Syndrome |
| ID | Term |
|---|---|
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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
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Cosmetic product "Onco-Repair" and placebo will be filled in the tubes with same appearance and smell. The tubes will be marked anonymusioly
Clinical parameters such as lesion color will be assessed
|
| Day 0 (inclusion) , Day 7 and Day 28 |
| Clinical parameters such as presence of blisters | Clinical parameters such as presence of blisters will be assessed
| Day 0 (inclusion) , Day 7 and Day 28 |
| Clinical parameters such as fissures/cracks | Clinical parameters such as fissures/cracks will be assessed
| Day 0 (inclusion) , Day 7 and Day 28 |
| Assessment of quality of life from D0 to D28 using Dermatology Life Quality Index scale | Quality of life will be assessed from D0 to D28 using Dermatology Life Quality Index scale. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions in over 80 countries and is available in over 90 languages. Meaning of Dermatology Life Quality Index scale Scores: 0 to 1 = no effect at all on patient's life 2 to 5 = small effect on patient's life 6 to 10 = moderate effect on patient's life 11 to 20 = very large effect on patient's life 21 to 30 = extremely large effect on patient's life | 28 days |
| Assessment of symptoms | Such as intensity of lesions, feeling of subjects, etc will be assessed: on e-CRF at D0, D7 and D28, from D0 to D28 using a standardized diary completed by subjects | 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)] | Pain score and prurit will be assessed 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 | The repair quality of skin will be assessed from D0, D7 and D28 using a standardized diary completed by subjects. | 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 | Nourishing power will be assessed at D28 using a standardized diary completed by subjects. | 28 days |
| Cosmetic parameters such as soothing power of the cream will be assessed at D28 using a standardized diary | Soothing power will be assessed at D28 using a standardized diary completed by subjects. | 28 days |
| Cosmetic parameters such as penetration power of the cream will be assessed at D28 using a standardized diary | Penetration power will be assessed at D28 using a standardized diary completed by subjects. | 28 days |
| Assessment of compliance | The compliance will be assessed at the end of the study: subject will be considered to be compliant if he/she applied at least the theoretical consumption of 60% of the product. | 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 |
| 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 | Safety will be assessed on the basis of adverse event (AE) reports | 28 days |
| D004342 |
| Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |