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

February 2, 2024 updated by: Luis A Perula, Hospital Universitario Reina Sofia de Cordoba

Effectivenes and Safety of a Cream of Aloe Vera, Camomila and Tomillo (Alantel) for Profilaxis or Treatmment of Deratitis by Radiotheraphy in Patients With Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Córdoba, Spain, 14011
        • University of Cordoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients 14 years of age or older
  • Diagnosed with cancer and who are or have recently received radiotherapy treatment.
  • We will include patients without dermatitis or with acute dermal posttradiotherapy lesions, in grades 1 and 2.

Exclusion Criteria:

  • Patients with dermal lesions in grade greater than 2.
  • Skin cancer invasion or distant tumor metastasis.
  • Concurrent chemotherapy with RT, severe / extensive burns, moisture, erosion or suppuration in the skin, history of connective tissue disorders, severe mental disorder (dementia, drug addiction, etc.).
  • History of hypersensitivity reaction to any of the ingredients of the studio cream.
  • Participants involved in other clinical trials within that month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Local administration of the Alantel (R) cream on the affected skin
Combination product: Cosmetic cream (Alantel (R): aloe vera, chamomile and thime)
Application on the affected skin of the cream to be tested
Placebo Comparator: Control group
Local administration of the Placebo cream on the affected skin
Combination product: Usual treatment
Application on the affected skin of the emollient and moisturizing substance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of radiation-induced dermatitis
Time Frame: three weeks
three weeks
Analog visual scale
Time Frame: three weeks
Analog visual scale from 0 to 10 points to assess the symptomatology perceived by the patient (pain, stinging, ..)
three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Reina Sofia de Cordoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2022

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

October 2, 2019

First Posted (Actual)

October 4, 2019

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alantel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER

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