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NCT06733545

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.

Completed Last updated 13 December 2024
What this trial tests

trial in Quality of Life (QOL) in 120 participants. Completed in 16 October 2024.

Timeline
4 April 2022
Primary endpoint
24 September 2024
16 October 2024

Quick facts

Lead sponsorPROSPERA BIOTECH S.L.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment120
Start date4 April 2022
Primary completion24 September 2024
Estimated completion16 October 2024
Sites1 location across Spain

Conditions studied

Sponsor

PROSPERA BIOTECH S.L.

Who can join

18 and older, any sex, with Quality of Life (QOL) or CIPN - Chemotherapy-Induced Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A topical nociceutical formulation ameliorates chemotherapy-induced peripheral neuropathy: a pilot randomized clinical study.
    Servitja S, Castro-Henriques M, Álvarez-Busto I, Díez-Franco C, et al · · 2026 · PMID 41032160 · DOI 10.1007/s12094-025-04062-1
  2. A Non-Pharmacological, Nociceutical Formulation Lessens Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients
    Servitja S, Castro-Henriques M, Álvarez-Busto I, Díez-Franco C, et al · · 2024 · DOI 10.1101/2024.12.29.24319628

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Other recruiting trials for Quality of Life (QOL)

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06733545.

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