Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-04-06 @ 11:44 AM
Study NCT ID:
NCT06427733
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2024-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Green Banana Peel Extract for Stasis Dermatitis Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017495', 'term': 'Hyperpigmentation'}], 'ancestors': [{'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-23', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-21', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of stasis dermatitis', 'timeFrame': '3 months', 'description': 'Macroscopic Analysis: The occurrence of stasis dermatitis will be determined by hyperpigmentation, measured using the Chromatic Palette. Changes in skin color vary from ecchymosis, hematomas, erythema, hyperpigmentation, hypochromia and cyanosis. The focus of our study being hyperpigmentation, the shades vary between brownish, grayish and reddish, depending on the evolution, clinical duration and skin color and severity of stasis dermatitis. The positioning of colors on a gradient scale in columns and lines favors the comparative process and location between nearby shades corresponding to the observed evidence. The inclusion of codes makes it possible to locate and classify skin colors in the situations in which they will be evaluated. In the final version that will be used, there are 72 color possibilities.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stasis dermatitis', 'Hyperpigmentation', 'banana skin', 'Musa sapientum'], 'conditions': ['Stasis Dermatitis']}, 'descriptionModule': {'briefSummary': 'To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of stasis dermatitis.', 'detailedDescription': 'Objective: to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of stasis dermatitis. Methods: it will be a clinical, interventional, longitudinal study, random sampling, Sample will have 20 patients divided into two groups. In the Control Group, a moisturizing cream with SPF 30 sunscreen plus a pharmaceutical formulation without green banana peel extract will be used, and in the Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used. Patients will undergo treatment for 90 days, applying the formulation twice a day, evaluated every 45 days through clinical, photographic and Chromatic Palette evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with stasis dermatitis.\n* Patients aged 18 years or over and 60 years or less.\n* Patients who agree to participate in the study. -\n\nExclusion Criteria:\n\n* Patients who have other types of hyperchromia in the legs.\n* Patients known to have an allergic reaction to bananas.\n* Patients who give up, for any reason, to continue treatment.'}, 'identificationModule': {'nctId': 'NCT06427733', 'briefTitle': 'Green Banana Peel Extract for Stasis Dermatitis Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Vale do Sapucai'}, 'officialTitle': 'Green Banana Peel Extract for Stasis Dermatitis Treatment', 'orgStudyIdInfo': {'id': 'Sponsor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group without green banana peel', 'description': 'SPF 30 and Placebo Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract', 'interventionNames': ['Biological: Placebo comparator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Study Group with green banana peel', 'description': 'SPF 30 and pharmaceutical formulation with green banana peel In Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing the extract of the green banana peel will be used.', 'interventionNames': ['Biological: Active Comparator']}], 'interventions': [{'name': 'Placebo comparator', 'type': 'BIOLOGICAL', 'description': 'SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract', 'armGroupLabels': ['Control Group without green banana peel']}, {'name': 'Active Comparator', 'type': 'BIOLOGICAL', 'description': 'SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract', 'armGroupLabels': ['Study Group with green banana peel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37550-000', 'city': 'Pouso Alegre', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Vale do Sapucaí University', 'geoPoint': {'lat': -22.23, 'lon': -45.93639}}], 'overallOfficials': [{'name': 'Adriana R dos Anjos Mendonça, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vale do Sapucaí University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Vale do Sapucai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}