Efficacy of the Cosmetic Product "Onco-Repair" on Grade 2 Hand Foot Syndrome

Phase 3CompletedNCT03612011

Quanta Medical72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Grade 2 Hand-foot Syndrom

Interventions

Onco-Repair/ PlaceboOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Quanta Medical

Rueil-Malmaison, France

Outcomes

Primary Outcomes

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.

Time frame: 28 days

Secondary Outcomes

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

Time frame: 28 days

Clinical parameters such as lesion color

Clinical parameters such as lesion color will be assessed * On e-CRF at D0, D7 and D28 * from D0 to D28 using a standardized diary completed by subjects

Time frame: 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 * On e-CRF at D0, D7 and D28 * from D0 to D28 using a standardized diary completed by subjects

Time frame: Day 0 (inclusion) , Day 7 and Day 28

Clinical parameters such as fissures/cracks

Clinical parameters such as fissures/cracks will be assessed * On e-CRF at D0, D7 and D28 * from D0 to D28 using a standardized diary completed by subjects

Time frame: Day 0 (inclusion) , Day 7 and Day 28

Data from ClinicalTrials.gov

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