Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:47 AM
Study NCT ID:
NCT03485560
Status:
UNKNOWN
Last Update Posted:
2018-04-02
First Post:
2017-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Revitalization of Damaged Skin Due to Chronic Skin Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-26', 'studyFirstSubmitDate': '2017-10-07', 'studyFirstSubmitQcDate': '2018-03-26', 'lastUpdatePostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regeneration of the damaged skin lesion', 'timeFrame': '6 - 9 months', 'description': 'Complete regeneration of the affected skin lesions from the skin disease.'}], 'secondaryOutcomes': [{'measure': 'Flare control', 'timeFrame': '1-3 months', 'description': 'During the attacks of flare, the regenerated skin does not get affected nor show erythematous reaction'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic skin disease', 'psoriasis', 'Eczema', 'atopic dermatitis'], 'conditions': ['Chronic Eczema', 'Psoriasis', 'Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'Chronic skin disease lead to skin damage and disfiguring to the patient skin. Sometimes, achieving normal skin is not possible by the normal traditional treatment, this study is focusing on use of ACE CSD formula which is mixture of natural peptides and herbs. the main aim is to restore the normal skin appearance for the patient and control the episodes of flare.', 'detailedDescription': 'Psoriasis is a chronic, immune mediated (type 2 and type 17) chronic skin disease. The production of the immune proteins that leads to continuous inflammatory mediated process. The result of chronic inflammation is they hyper keratotic layer of skin which gets attacks of atopic dermatitis leading to symptoms of itching, pruritis and in situ bleeding.\n\nACE CSD, with the multiple factors that mediates the immune response and control the protein receptors, in addition to the multiple regeneration peptides that are specifically extracted from healthy skin of newly born sheep; in addition to multiple Chinese herbs that contains different anabolic factors was tested to be able to regenerate the damaged skin and locally modulate the immunity reactions so the skin can regenerate fully to replace the damaged skin with normal healthy skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic skin condition lasts for more than 1 year.\n* tried traditional treatment with limited or without effect.\n* not on steroids for at least 6 weeks.\n\nExclusion Criteria:\n\n* patients on steroid.\n* patients intolerable to protein or allergic to proteins\n* during pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT03485560', 'briefTitle': 'Revitalization of Damaged Skin Due to Chronic Skin Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ace Cells Lab Limited'}, 'officialTitle': 'Revitalization of Damaged Sking Due to Chronic Skin Diseases', 'orgStudyIdInfo': {'id': 'ACEcsd'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'internvention of Chrinic skin conditions', 'description': 'All cases of chronic skin conditions will be included to measure the effect on the 3 of them and whihc one will respond to the treatment better', 'interventionNames': ['Combination Product: ACE CSD']}], 'interventions': [{'name': 'ACE CSD', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['ACE Skin immune'], 'description': 'Topical application of the ACE CSD 4 times daily.', 'armGroupLabels': ['internvention of Chrinic skin conditions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'contacts': [{'name': 'Dr. Diana Diana, MsC dermatology', 'role': 'CONTACT', 'email': 'dr.dianadiana@outlook.com'}], 'facility': 'ACE cells Lab Europe Doo', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': 'NG90 6BH', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'contacts': [{'name': 'Dr. Alaa Abdelkarim MF Mohammed, Consultant', 'role': 'CONTACT', 'email': 'dralaakarim@gmail.com', 'phone': '7473922553'}], 'facility': 'ACE Cells Lab Limited', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'centralContacts': [{'name': 'Dr. Alaa Abdelkarim MF Mohammed', 'role': 'CONTACT', 'email': 'dralaakarim@gmail.com', 'phone': '+447473922553'}, {'name': 'Dr. Diana Diana, MsC Dermatology', 'role': 'CONTACT', 'email': 'dr.dianadiana@outlook.com'}], 'overallOfficials': [{'name': 'Dr. Diana Diana, MSc Dermatology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ACE cells Lab europe DOO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ace Cells Lab Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}