Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT04116151
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2019-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Cream for Treatment of Dermatitis in Patients Whith Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003872', 'term': 'Dermatitis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713170', 'term': 'Chamomile extract'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Double blind: both the patient and the healthcare professional do not know if the cream to be tested or the placebo is applied'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicenter study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2019-09-18', 'studyFirstSubmitQcDate': '2019-10-02', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of radiation-induced dermatitis', 'timeFrame': 'three weeks'}, {'measure': 'Analog visual scale', 'timeFrame': 'three weeks', 'description': 'Analog visual scale from 0 to 10 points to assess the symptomatology perceived by the patient (pain, stinging, ..)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BREAST CANCER', 'DERMATITIS'], 'conditions': ['DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER']}, 'referencesModule': {'references': [{'pmid': '38273379', 'type': 'DERIVED', 'citation': 'Jimenez-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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 14 years of age or older\n* Diagnosed with cancer and who are or have recently received radiotherapy treatment.\n* We will include patients without dermatitis or with acute dermal posttradiotherapy lesions, in grades 1 and 2.\n\nExclusion Criteria:\n\n* Patients with dermal lesions in grade greater than 2.\n* Skin cancer invasion or distant tumor metastasis.\n* 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.).\n* History of hypersensitivity reaction to any of the ingredients of the studio cream.\n* Participants involved in other clinical trials within that month.'}, 'identificationModule': {'nctId': 'NCT04116151', 'acronym': 'Alantel', 'briefTitle': 'Effectiveness of a Cream for Treatment of Dermatitis in Patients Whith Breast Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Universitario Reina Sofia de Cordoba'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Alantel'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Cosmetic cream (Alantel (R): aloe vera, chamomile and thime)', 'type': 'COMBINATION_PRODUCT', 'description': 'Application on the affected skin of the cream to be tested', 'armGroupLabels': ['Intervention group']}, {'name': 'Usual treatment', 'type': 'COMBINATION_PRODUCT', 'description': 'Application on the affected skin of the emollient and moisturizing substance', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14011', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'University of Cordoba', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Reina Sofia de Cordoba', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Luis A Perula', 'investigatorAffiliation': 'Hospital Universitario Reina Sofia de Cordoba'}}}}