Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-01-01 @ 5:26 PM
Study NCT ID:
NCT07041892
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-27
First Post:
2025-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of an Oral Prebiotic and an Oral Synbiotic Supplement in Combination With a Topical Lotion and Soap On Eczema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2025-06-19', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective and Subjective Scoring of Eczema Severity', 'timeFrame': '8 weeks', 'description': 'Change in eczema severity was assessed using SCORAD (SCOring of Atopic Dermatitis). A. First, the spread of eczema on different body areas is assessed by the investigator and calculated as a percent, where the maximum is 100%. B. Second, the intensity of skin redness, swelling, oozing, scratch marks, skin thickening and dryness is scored by the investigator from 0 to 3, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. C. Finally, for the subjective score, participants are asked to report the intensity of symptoms (itch and sleeplessness) from 0 to 10, where 0 is no itch or no sleeplessness, and 10 is the worst imaginable itch or insomnia sleeplessness. The total score of the objective SCORAD is obtained with the following formula: SCORAD = A/5 + 7 B/2 + C'}, {'measure': 'Localized Eczema Severity', 'timeFrame': '8 weeks', 'description': 'Change in localized eczema severity is assessed with the Eczema Area and Severity Index (EASI). Skin redness, elevation, scratching, and thickening are assessed by the investigator on a scale of 0 to 3, where 0 is none, 1 is mild, 2 is moderate, 3 is severe. The localized EASI is the sum of these scores.'}, {'measure': 'Objective and Subjective Scoring of Eczema Severity', 'timeFrame': '4 weeks', 'description': 'Change in eczema severity was assessed using SCORAD (SCOring of Atopic Dermatitis). A. First, the spread of eczema on different body areas is assessed by the investigator and calculated as a percent, where the maximum is 100%. B. Second, the intensity of skin redness, swelling, oozing, scratch marks, skin thickening and dryness is scored by the investigator from 0 to 3, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. C. Finally, for the subjective score, participants are asked to report the intensity of symptoms (itch and sleeplessness) from 0 to 10, where 0 is no itch or no sleeplessness, and 10 is the worst imaginable itch or insomnia sleeplessness. The total score of the objective SCORAD is obtained with the following formula: SCORAD = A/5 + 7 B/2 + C'}, {'measure': 'Localized Eczema Severity', 'timeFrame': '4 weeks', 'description': 'Change in localized eczema severity is assessed with the Eczema Area and Severity Index (EASI). Skin redness, elevation, scratching, and thickening are assessed by the investigator on a scale of 0 to 3, where 0 is none, 1 is mild, 2 is moderate, 3 is severe. The localized EASI is the sum of these scores.'}], 'secondaryOutcomes': [{'measure': 'Skin Hydration', 'timeFrame': '4 weeks', 'description': 'Change in skin hydration is assessed with a Corneometer.'}, {'measure': 'Skin Hydration', 'timeFrame': '8 weeks', 'description': 'Change in skin hydration is assessed with a Corneometer.'}, {'measure': 'Transepidermal Water Loss', 'timeFrame': '4 weeks', 'description': 'Change in transepidermal water loss is assessed with a Tewameter TM 300'}, {'measure': 'Transepidermal Water Loss', 'timeFrame': '8 weeks', 'description': 'Change in transepidermal water loss is assessed with a Tewameter TM 300'}, {'measure': 'Desquamation Index', 'timeFrame': '4 weeks', 'description': 'Change in desquamation is assessed with D-Squam®.'}, {'measure': 'Desquamation Index', 'timeFrame': '8 weeks', 'description': 'Change in desquamation is assessed with D-Squam®.'}, {'measure': 'Positive and Negative Affect', 'timeFrame': '4 weeks', 'description': 'Change in mood is assessed with the PANAS-SF (Positive and Negative Affect Schedule- Short Form). Participants are asked to evaluate the degree to which they experienced components of positive and negative affect : Interested, Distressed, Excited, Upset, Strong, Guilty, Scared, Hostile, Enthusiastic, Proud, Irritable, Alert, Ashamed, Inspired, Nervous, Determined, Attentive, Jittery, Active, and Afraid. A 5-point scale was used where 1 is very slightly or not at all, 2 is a little, 3 is moderately, 4 is quite a bit, and 5 is extremely.'}, {'measure': 'Positive and Negative Affect', 'timeFrame': '8 weeks', 'description': 'Change in mood is assessed with the PANAS-SF (Positive and Negative Affect Schedule- Short Form). Participants are asked to evaluate the degree to which they experienced components of positive and negative affect : Interested, Distressed, Excited, Upset, Strong, Guilty, Scared, Hostile, Enthusiastic, Proud, Irritable, Alert, Ashamed, Inspired, Nervous, Determined, Attentive, Jittery, Active, and Afraid. A 5-point scale was used where 1 is very slightly or not at all, 2 is a little, 3 is moderately, 4 is quite a bit, and 5 is extremely.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eczema', 'supplement', 'dry skin', 'lotion', 'prebiotic', 'synbiotic'], 'conditions': ['Atopic Dermatitis (Eczema)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effects of 2 dietary supplements (an oral prebiotic and an oral synbiotic) in combination with a topical lotion, and an unscented soap on eczema severity, various skin measures (such as skin hydration), and mood in those with eczema.\n\nA prebiotic supplement contains ingredients that can get broken down by the bacteria in the gut.\n\nA synbiotic supplement contains prebiotic and probiotic ingredients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sex: female and male;\n* Age : 18 years old and above;\n* Phototype: I to IV;\n* Type: Caucasian;\n* Subjects with active eczema condition the body (showing flakiness, irritation, itch and intense dryness);\n* Subjects with a SCORAD of 25 - 50;\n* Local EASI score of 0-15:\n\n * 30% - 4-5\n * 30%- 6-7\n * 30% - 8-9\n* Subjects with dry and very dry skin on the study areas (cutaneous hydration rate \\< 50 A.U);\n* Subjects must not take antibiotics and / or apply any antifungal treatments (body/scalp) for 1 month before study start and during the entire study duration;\n* No change in hygiene, cosmetics, and make-up habits - except for the product(s) under study - during the entire study duration;\n* Subjects agreeing not to change lifestyle habits during the study duration\n* Healthy subject;\n* Subject having given her free informed, written consent;\n* Subject willing to adhere to the protocol and study procedures;\n* Subject with Polish citizenship.\n\nExclusion Criteria:\n\n* For women with childbearing potential: pregnant or nursing woman or woman planning to get pregnant during the study;\n* Cutaneous pathology on the study zone (other than eczema);\n* Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability/efficacy of the study product (the subjects are allowed to use their topical corticosteroids during the study if needed; the information about the treatment and the number of applications must be noted in the daily log);\n* Subject having undergone a surgery under general anesthesia within the previous month;\n* Excessive exposure to sunlight or UV-rays within the previous month;\n* Subject enrolled in another clinical trial during the study period (concerns the studied zones).'}, 'identificationModule': {'nctId': 'NCT07041892', 'briefTitle': 'The Effects of an Oral Prebiotic and an Oral Synbiotic Supplement in Combination With a Topical Lotion and Soap On Eczema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Codex Labs Corporation'}, 'officialTitle': 'Clinical and Instrumental Efficacy Evaluation Of Oral Prebiotic + Synbiotic Food Supplement Tested With Topical Lotion + Soap On Subjects With Atopic Dermatitis- Use Test Under Dermatological Control', 'orgStudyIdInfo': {'id': '#STUU524AA0877'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participant', 'description': "The participant is provided with and instructed to use an oral prebiotic supplement and an oral synbiotic supplement for the duration of the study. In addition, the participant is also provided with and instructed to use a topical lotion to use in replacement of of the participants usual moisturizing product and an unscented soap, in replacement of the participant's usual cleansing product for the duration of the study.", 'interventionNames': ['Other: Prebiotic Supplement + Synbiotic Supplement + Topical Lotion + Unscented Soap']}], 'interventions': [{'name': 'Prebiotic Supplement + Synbiotic Supplement + Topical Lotion + Unscented Soap', 'type': 'OTHER', 'description': 'The intervention includes 4 products:\n\n1. An oral prebiotic dietary supplement\n2. An oral synbiotic dietary supplement\n3. A topical lotion\n4. An unscented bar of soap', 'armGroupLabels': ['Participant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gdansk', 'country': 'Poland', 'facility': 'Eurofins Dermscan Poland', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will need to be protected for patentability reasons while IP is being filed. Once IP considerations are finalized, data can be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Codex Labs Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eurofins Dermscan Pharmascan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}