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

Quanta Medical

Status and phase

Completed

Phase 3

Conditions

Grade 2 Hand-foot Syndrom

Treatments

Other: Onco-Repair/ Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03612011

NAOS_ONCOREPAIR_PP_17_2851

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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