Clinical trial · Interventional
Effectiveness of a Cream for Treatment of Dermatitis in Patients Whith Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cosmetic cream (Alantel (R): aloe vera, chamomile and thime) | Combination Product | — | UNRESOLVED |
| Usual treatment | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Local administration of the Alantel (R) cream on the affected skin
- interventionNames
- Combination Product: Cosmetic cream (Alantel (R): aloe vera, chamomile and thime)
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Local administration of the Placebo cream on the affected skin
- interventionNames
- Combination Product: Usual treatment
Primary outcomes (2)
- measure
- Incidence of radiation-induced dermatitis
- timeFrame
- three weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDJimenez-Garcia C, Perula-de Torres LA, Villegas-Becerril E, Munoz-Gavilan JJ, Espinosa-Calvo M, Montes-Redondo G, Romero-Rodriguez E; Alantel Trial Collaborative Group. Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients: a controlled clinical trial (Alantel Trials). Trials. 2024 Jan 25;25(1):84. doi: 10.1186/s13063-024-07901-8. PMID 38273379