Study for the Evaluation of the Degree of Skin Satisfaction of a Cosmetic Cream for Sensitive Skin in Oncological Patients Affected by a Palmoplantar Polyneuropathy Secondary to Chemotherapy.

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.

Conditions

• Quality of Life (QOL)
• CIPN - Chemotherapy-Induced Peripheral Neuropathy

Sponsors & Collaborators

• Hospital General Universitario Elche

  collaborator OTHER

• Hospital Miguel Servet

  collaborator OTHER

• Hospital del Mar

  collaborator OTHER

• Hospital Marina Baixa, Alicante

  collaborator UNKNOWN

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Hospital General Universitario Santa Lucia

  collaborator OTHER

• Hospital Universitari Sagrat Cor, Barcelona

  collaborator UNKNOWN

• Hospital General de Elda

  collaborator OTHER

• Centre Hospitalier Universitaire Saint Pierre

  collaborator OTHER

• Universidad Miguel Hernandez de Elche

  collaborator OTHER

• PROSPERA BIOTECH S.L.

  lead INDUSTRY

Principal Investigators

• Antonio Sonia Servitja, Oncologist · Servicio de Oncología Médica, Hospital del Mar, 08003 Barcelona (Spain)

• Maria Castro-Henriques, Oncologist · Servicio de Oncología Médica, Hospital del Mar, 08003 Barcelona (Spain)

• Iñaki Álvarez-Busto, Oncologist · Servicio de Oncología Médica, Hospital Universitario Miguel Servet, 50009 Zaragoza (Spain)

• Maria Asunción Algarra-García, Oncologist · Servicio de Oncología Médica, Hospital Marina Baixa, 03570 Villajoyosa, Alicante (Spain)

• Elena López-Miranda, Oncologist · Servicio de Oncología Médica, Hospital Universitario Ramon y Cajal, 28034 Madrid (Spain)

• Maria I Luengo-Alcázar, Oncologist · Servicio de Oncología Médica, Hospital General Universitario Santa Lucía, 30202 Cartagena, Murcia (Spain)

• Miguel Borregón, Oncologist · Servicio de Oncología Médica, Hospital General Universitario de Elche, 03202 Elche, Alicante (Spain)

• Anna Gassull-Delgado, Nursery · Servicio de Oncología Médica, Hospital Universitari Sagrat Cor, 08029 Barcelona (Spain)

• Ana Gonzaga-López, Oncologist · Servicio de Oncología Médica, Hospital General Universitario de Elda, 03600 Elda, Alicante (Spain)

• Jesus M Poveda-Ferriols, Oncologist · CHU St-Pierre-UMC St-Pieter, 1000 Brussels (Belgium)

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-04

Primary Completion

2024-09-24

Completion

2024-10-16

Countries

• Spain

Study Locations