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Effectiveness of a Cream for Treatment of Dermatitis in Patients Whith Breast Cancer

NCT04116151 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-02-05

No results posted yet for this study

Summary

It is intended to evaluate the effect of a marketed cream (Alantel®) based on natural products at high concentrations for the preventive and curative treatment (early stages) of radiation-induced dermatitis in cancer patients. For this, an experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicentre, will be carried out in which doctors will recruit 78 patients aged 14 years or over in Primary Care consultations. more, diagnosed with cancer, and having received radiotherapeutic cancer treatment, being randomly assigned to the experimental group (cosmetic cream) or the control group (emollient and moisturizing cream). The main variable will be the incidence rate of mild post-translational dermatitis and its improvement or cure once it has been established.

Conditions

  • DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER

Interventions

COMBINATION_PRODUCT

Cosmetic cream (Alantel (R): aloe vera, chamomile and thime)

Application on the affected skin of the cream to be tested

COMBINATION_PRODUCT

Usual treatment

Application on the affected skin of the emollient and moisturizing substance

Sponsors & Collaborators

  • Hospital Universitario Reina Sofia de Cordoba

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-19
Primary Completion
2023-05-30
Completion
2023-07-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04116151 on ClinicalTrials.gov