Grade 2 Hand-foot Syndrom Clinical Trial
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.
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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