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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.
trial in Quality of Life (QOL) in 120 participants. Completed in 16 October 2024.
24 September 2024
Quick facts
| Lead sponsor | PROSPERA BIOTECH S.L. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 4 April 2022 |
| Primary completion | 24 September 2024 |
| Estimated completion | 16 October 2024 |
| Sites | 1 location across Spain |
Conditions studied
- Quality of Life (QOL) — all drugs for Quality of Life (QOL) →
- CIPN - Chemotherapy-Induced Peripheral Neuropathy — all drugs for CIPN - Chemotherapy-Induced Peripheral Neuropathy →
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):
-
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 -
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
Verify or expand the search:
- PubMed search for NCT06733545
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06733545 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PROSPERA BIOTECH S.L.
- Last refreshed: 13 December 2024
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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