Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:06 AM
Study NCT ID:
NCT07479004
Status:
COMPLETED
Last Update Posted:
2026-03-23
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cream Paste Containg Pleuran on Selected Skin Dermatoses (Neonatal Pustulosis, Diaper Dermatitis, Perioral Dermatitis).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003963', 'term': 'Diaper Rash'}, {'id': 'D019557', 'term': 'Dermatitis, Perioral'}, {'id': 'D004890', 'term': 'Erythema'}], 'ancestors': [{'id': 'D017453', 'term': 'Dermatitis, Irritant'}, {'id': 'D003877', 'term': 'Dermatitis, Contact'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D005148', 'term': 'Facial Dermatoses'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-01', 'size': 361808, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-03-13T06:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Clinician's Erythema Assessment", 'timeFrame': 'from the enrolment (day 1;V0) to complete recovery from erythema (latest on day 14; V1) at each study visit Evaluations: - initial visit (V0) - day of enrolment - control visit (V1) - after complete recovery from erythema or max. 14 days from enrolment', 'description': 'Clinical assessment of erythema using a 5-point severity scale (0 = no erythema; 1 = very mild erythema: light pink; 2 = mild erythema: pink; 3 = moderate erythema: red; 4 = severe erythema: intense red)'}, {'measure': "Investigator's Global Assessment (IGA)", 'timeFrame': 'from the enrolment (day 1; V0) to complete recovery from erythema (latest on day 14; V1) initial visit (V0) - day of enrolment control visit (V1) - after complete recovery from erythema or maximum 14 days from enrolment', 'description': "Overall severity and improvement of selected dermatoses (diaper dermatitis, perioral dermatitis, neonatal dermatitis) evaluated by Investigator's global assessment (IGA) using a 6-point scale (-1 = worsening; 0 = no response; 1 = mild response; 2 = moderate response; 3 = excellent response; 4 = complete response)"}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'from the enrolment (day 1; V0) to complete recovery from erythema (latest on day 14; V1)', 'description': 'Safety was monitored by number of participants with treatment-related adverse events.'}, {'measure': 'Tolerability of the cosmetic product', 'timeFrame': 'from the enrolment (day 1; V0) to complete recovery from erythema (latest on day 14; V1) Evaluation at control visit (V1) - after complete recovery from erythema or maximum 14 days from enrolment', 'description': 'Tolerability was assessed by product acceptance and adherence to study treatment using a 3-point tolerability scale (0 = poor; 1 = good; 2 = excellent)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pleuran', 'beta-glucan', 'neonatal pustulosis', 'diaper dermatitis', 'perioral dermatitis', 'zinc oxide', 'periorificial dermatitis', 'overall improvement of erythema severity', 'reduction of erythema severity'], 'conditions': ['Diaper Dermatitis', 'Perioral Dermatitis', 'Neonatal Pustulosis', 'Periorificial Dermatitis', 'Erythema']}, 'descriptionModule': {'briefSummary': 'In this multicentre, prospective clinical research conducted in outpatient healthcare facilities, the investigators studied the effect of novel cosmetic product Imunoglukan P4H® ACUTE! cream paste in children with neonatal pustulosis, diaper dermatitis or perioral dermatitis. The main endpoints of the study were focused on objective evaluation of erythema severity and overall improvement of selected dermatoses.\n\nParticipants enrolled in the study applied Imunoglukan P4H® ACUTE! cream paste at least 2-3 times daily (or as needed) in an adequate amount to the affected area for a maximum of 2 weeks (without other treatment).', 'detailedDescription': "* Design: Multicentre, prospective, open-label study\n* Centres: 20 outpatient healthcare facilities in Slovakia (1 Department of Dermatology, 19 general outpatient clinic for children and adolescents)\n* Patients: 110 children from 3 weeks of age with selected skin dermatoses (neonatal pustulosis, diaper dermatitis, perioral dermatitis)\n* Treatment: Imunoglukan P4H® ACUTE! cream paste applied 2-3 times a day or as needed (without other treatment)\n* Study period: until erythema disappears or for a maximum of 14 days\n* Primary endpoints:\n* severity of erythema according to 5-point scale (Clinician's Erythema Assessment - CEA)\n* overall severity and improvement of selected dermatoses according to 6-point scale (Investigator's Global Assessment - IGA)\n* Secondary endpoint:\n* tolerability of novel cosmetic product (Clinician's Assessment of Tolerability)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed informed consent\n* age from 3 weeks\n* at least one of the following diagnoses: perioral dermatitis, diaper dermatitis, neonatal pustulosis\n\nExclusion Criteria:\n\n* refused to sign informed consent\n* application of topical corticosteroids, antihistamines, other immunomodulatory preparations (e.g. beta-glucans) at time of inclusion\n* using of oral corticosteroids, antihistamines at time of inclusion\n* known intolerance to any ingredients contained in the investigational product'}, 'identificationModule': {'nctId': 'NCT07479004', 'acronym': 'ECESID', 'briefTitle': 'Effect of Cream Paste Containg Pleuran on Selected Skin Dermatoses (Neonatal Pustulosis, Diaper Dermatitis, Perioral Dermatitis).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pleuran, s.r.o.'}, 'officialTitle': 'Effect of Cream Paste Containg Pleuran (β-glucan From Pleurotus Ostreatus) on Selected Skin Dermatoses.', 'orgStudyIdInfo': {'id': 'ECESID'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active group', 'interventionNames': ['Other: Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste']}], 'interventions': [{'name': 'Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste', 'type': 'OTHER', 'description': 'cream-paste based on pleuran, zinc oxide, hyaluronic acid and vitamin E', 'armGroupLabels': ['Active group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '974 01', 'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '821 01', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '821 07', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '841 01', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '841 07', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '851 01', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '977 01', 'city': 'Brezno', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 48.80431, 'lon': 19.63631}}, {'zip': '026 01', 'city': 'Dolný Kubín', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 49.20983, 'lon': 19.30341}}, {'zip': '929 01', 'city': 'Dunajská Streda', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 47.99268, 'lon': 17.61211}}, {'zip': '04001', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '036 01', 'city': 'Martin', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'zip': '034 01', 'city': 'Ružomberok', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 49.0748, 'lon': 19.30751}}, {'zip': '917 01', 'city': 'Trnava', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 48.37773, 'lon': 17.58603}}, {'zip': '95301', 'city': 'Zlaté Moravce', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 48.38553, 'lon': 18.40063}}, {'zip': '96501', 'city': 'Žiar nad Hronom', 'country': 'Slovakia', 'facility': 'General outpatient clinic for children and adolescents', 'geoPoint': {'lat': 48.59184, 'lon': 18.84958}}], 'overallOfficials': [{'name': 'Karolina Vorcakova, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatovenerology, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava, University Hospital Martin, Kollarova 2, 036 59 Martin, Slovakia'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pleuran, s.r.o.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}