Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT01124318
Status:
COMPLETED
Last Update Posted:
2010-09-14
First Post:
2010-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'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': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007792', 'term': 'Lactulose'}, {'id': 'D008031', 'term': 'Lignin'}], 'ancestors': [{'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002482', 'term': 'Cellulose'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-13', 'studyFirstSubmitDate': '2010-04-28', 'studyFirstSubmitQcDate': '2010-05-13', 'lastUpdatePostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SCORAD Index', 'timeFrame': 'Day 21 after start of the intervention', 'description': 'The Scoring of Atopic Dermatitis (SCORAD) index is a composite index (0-100 scores) measured by blinded physician assessing three main clinical features of the disease (separate scales), namely area of lesion, clinical severity, subjective symptoms.'}], 'secondaryOutcomes': [{'measure': 'SCORAD Index', 'timeFrame': 'Day 30 after end of the intervention', 'description': 'The Scoring of Atopic Dermatitis (SCORAD) index is a composite index (0-100 scores) measured by blinded physician assessing three main clinical features of the disease (separate scales), namely area of lesion, clinical severity, subjective symptoms.'}, {'measure': 'SCORAD Index', 'timeFrame': 'Day 10 after start of the intervention', 'description': 'The Scoring of Atopic Dermatitis (SCORAD) index is a composite index (0-100 scores) measured by blinded physician assessing three main clinical features of the disease (separate scales), namely area of lesion, clinical severity, subjective symptoms.'}, {'measure': 'Dermatological Index of Life Quality', 'timeFrame': 'Day 10 after start of the intervention', 'description': "The Dermatological Index of Life Quality is a index (0-30 scores) representing patient's life quality deteriorations related to a skin disease (self-reported questionnaire)."}, {'measure': 'Dermatological Index of Life Quality', 'timeFrame': 'Day 21 after start of the intervention', 'description': "The Dermatological Index of Life Quality is a index (0-30 scores) representing patient's life quality deteriorations related to a skin disease (self-reported questionnaire)."}, {'measure': 'Dermatological Index of Life Quality', 'timeFrame': 'Day 30 after end of the intervention', 'description': "The Dermatological Index of Life Quality is a index (0-30 scores) representing patient's life quality deteriorations related to a skin disease (self-reported questionnaire)."}, {'measure': 'BRS Index', 'timeFrame': 'Day 10 after start of the intervention', 'description': 'Behavioral rating scores (BRS) measures severity of itching.'}, {'measure': 'BRS Index', 'timeFrame': 'Day 21 after start of the intervention', 'description': 'Behavioral rating scores (BRS) measures severity of itching.'}, {'measure': 'BRS Index', 'timeFrame': 'Day 30 after end of the intervention', 'description': 'Behavioral rating scores (BRS) measures severity of itching.'}, {'measure': 'Blood test', 'timeFrame': 'Day 21 after start of the intervention', 'description': "It includes routine blood cells' counting and measurement of erythrocyte sedimentation rate and serum concentration of hemoglobin."}, {'measure': 'Biochemical blood analysis', 'timeFrame': 'Day 21 after start of the intervention', 'description': 'It includes routine measurements of serum concentrations of biochemical compounds including proteins, glucose, enzymes, creatinine, urea, potassium, sodium, bilirubin.'}, {'measure': 'Urine analysis', 'timeFrame': 'Day 21 after start of the intervention', 'description': 'It includes routine measurements of urine concentrations of biochemical compounds including proteins and glucose, counting of cells, detection of bacteria and urinometry.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lactofiltrum', 'atopic dermatitis', 'itching', 'Dermatological Index of Life Quality', 'SCORAD', 'Behavioral Rating Scores'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose is to study efficacy of Lactofiltrum in adult patients with atopic dermatitis. Lactofiltrum consists of 85% of hidrolytic lignin and 15% of lactulose and acts as an enterosorbent, which enables to enhance metabolism and elimination of endotoxins and to normalize metabolic and immune processes. Additionally, lactulose stimulates Bifidobacterium flora and in aggregate it could improve skin condition afflicted by atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18-60 y.o. diagnosed with atopic dermatitis according to the UK refinement of the Hanifin-Rajka diagnostic criteria;\n* SCORAD Index more than 25.\n\nExclusion Criteria:\n\n* pregnancy and breast-feeding;\n* severe diseases;\n* concomitant infection diseases (including parasitic ones);\n* diffusive connective-tissue (autoimmune) diseases;\n* renal and hepatic failure;\n* systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolite agents by the time of inclusion into the study;\n* concomitant skin diseases: skin lymphoma, scab, lichen ruber planus, psoriasis;\n* professional activity involving skin injury, exposure to cold, insolation, ultraviolet radiation;\n* psychoses;\n* application of pre-, probiotics, antibiotics, neuroleptics or tranquilizers 2 weeks before inclusion or during participation in the study;\n* participation in other clinical study 1 month before inclusion or during participation in the proposed study.'}, 'identificationModule': {'nctId': 'NCT01124318', 'acronym': 'LF-AD-09', 'briefTitle': 'A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avva Rus, JSC'}, 'officialTitle': 'Phase II Double Blind Placebo-controled Randomized Comparative Multicentered Study of Efficacy and Safety of Lactofiltrum, Orally Administered Tablets (Produced by AVVA RUS, JSC) to Treat Atopic Dermatitis in Adults', 'orgStudyIdInfo': {'id': '04/09-AVVA RUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lactofiltrum', 'interventionNames': ['Drug: Lactofiltrum']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lactofiltrum', 'type': 'DRUG', 'otherNames': ['Lactulose', 'Lignin'], 'description': 'Lactofiltrum (hydrolytic lignin 0.355, lactulose 0.12) 2 tablets three times a day before meals during 21 days', 'armGroupLabels': ['Lactofiltrum']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 2 tablets 3 times a day before meals during 21 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119071', 'city': 'Moscow', 'state': 'Moscow', 'country': 'Russia', 'facility': 'Moscow Dermatovenerologic Clinical Dispensary № 1', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '127473', 'city': 'Moscow', 'state': 'Moscow', 'country': 'Russia', 'facility': 'Moscow State University of Medicine and Dentistry', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Yuriy Perlamutrov, MD, DrSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moscow State University of Medicine and Dentistry'}, {'name': 'Nickolay A. Kryuchkov, MD, PhD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Avva Rus, JSC'}, {'name': 'Lyudmila Kobeleva, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Avva Rus, JSC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avva Rus, JSC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Moscow State University of Medicine and Dentistry', 'class': 'OTHER'}, {'name': 'Moscow Dermatovenerologic Clinical Dispensary № 1', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Prof. Yuriy Perlamutrov, Head of dermatovenerologic diseases department', 'oldOrganization': 'Moscow State University of Medicine and Dentistry'}}}}