At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study for the Evaluation of the Degree of Skin Satisfaction of Cosmetics Creams PB-011 and PB-012 for Sensitive Skin in Oncological Patients Affected by a Palmoplantar Polyneuropathy Secondary to Chemotherapy or Chemotherapeutic Agents' Fusion to Monoclonal Antibodies (Immunocitostatics)
In Brief
An observational study for Quality of Life (QOL) and CIPN - Chemotherapy-Induced Peripheral Neuropathy. Completed, enrolled 120 participants across 1 site.
Detailed Summary
It is proposed a controlled research study aimed to evaluating and comparing the degree of skin satisfaction and comfort with cosmetic creams PB-011 and PB-012 in cancer patients who can develop a palmar and plantar peripheral polyneuropathy by treatment with chemotherapy. Both products are cosmetic creams derived from the cosmetic Nocisens® line (for the care of sensitive skin with atopic tendency). The hypothesis that is proposed to test is that the care with PB-011 or PB-012 of the sensitive skin associated with palmar and plantar peripheral polyneuropathy of cancer patients will increase their degree of satisfaction and skin comfort. This study is proposed in patients who are going to start chemotherapeutic treatment. The study conceives two populations: (i) population where PB-011 cream will be tested; and (ii) population that will test PB-012 cream. A sample size of 60 volunteers per population has been estimated to ensure statistical significance. As a qualitative relevant variable for patients, the degree of satisfaction and skin comfort of the volunteers will be assessed by means of questionnaires.