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CompletedNCT04116151AlantelUpdated Feb 5, 2024

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

An interventional study of Cosmetic cream (Alantel (R): aloe vera, chamomile and thime) and Usual treatment in DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER, sponsored by Hospital Universitario Reina Sofia de Cordoba. Completed at 1 site in Spain. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by Hospital Universitario Reina Sofia de Cordoba · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
14 Years and older
Sex
All
01

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.

02

Conditions studied

  • DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER

Keywords

  • BREAST CANCER
  • DERMATITIS
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 78 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Hospital Universitario Reina Sofia de Cordoba is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
78 participants (actual)

Study arms

  • 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)

  • Placebo comparator
    Control group

    Local administration of the Placebo cream on the affected skin

    Combination Product: Usual treatment

Interventions

  • Combination productCosmetic cream (Alantel (R): aloe vera, chamomile and thime)

    Application on the affected skin of the cream to be tested

  • Combination productUsual treatment

    Application on the affected skin of the emollient and moisturizing substance

06

What researchers measure

Primary outcomes

  1. Incidence of radiation-induced dermatitis

    Time frame: three weeks

  2. Analog visual scale

    Analog visual scale from 0 to 10 points to assess the symptomatology perceived by the patient (pain, stinging, ..)

    Time frame: three weeks

07

Study locations

1 site
  • University of Cordoba
    Córdoba, 14011, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04116151
Lead sponsor
Hospital Universitario Reina Sofia de Cordoba
Responsible party
Luis A Perula (Clinical Professor, Hospital Universitario Reina Sofia de Cordoba) — Principal investigator
First posted
Oct 4, 2019
Start date
Jul 19, 2022
Primary completion
May 30, 2023
Completion
Jul 30, 2023
Last update
Feb 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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