Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
Study NCT ID:
NCT03902392
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2019-02-14
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017449', 'term': 'Dermatitis, Allergic Contact'}], 'ancestors': [{'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': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thea.magrone@uniba.it', 'phone': '+39 080 5478584', 'title': 'Thea TM Magrone, BD', 'organization': 'University of Bari'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'NATUR-OX Group (A)', 'description': 'Administration, for three months (T1), of NATUR-OX® capsule/day. NATUR-OX® which is a dietary supplement containing grape seed extracts from Nero di Troia (Vitis vinifera). Each capsule contains 280 mg of proanthocyanidins where Ni contamination of capsule is below 0.24 ppm\n\nNaturOx Group (A): Comparison between dietary supplement and placebo', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Group (B)', 'description': 'Administration with placebo one capsule/daily for three months. The placebo capsules had the same appearance and composition of the supplement except for the active ingredient (polyphenols)\n\nPlacebo Group (B): Comparison between dietary supplement and placebo', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NATUR-OX Group (A)', 'description': 'Administration, for three months (T1), of NATUR-OX® capsule/day. NATUR-OX® which is a dietary supplement containing grape seed extracts from Nero di Troia (Vitis vinifera). Each capsule contains 280 mg of proanthocyanidins where Ni contamination of capsule is below 0.24 ppm\n\nNaturOx Group (A): Comparison between dietary supplement and placebo'}, {'id': 'OG001', 'title': 'Placebo Group (B)', 'description': 'Administration with placebo one capsule/daily for three months. The placebo capsules had the same appearance and composition of the supplement except for the active ingredient (polyphenols)\n\nPlacebo Group (B): Comparison between dietary supplement and placebo'}], 'classes': [{'title': 'IFN-γ (measurement unit: pg/ml)', 'categories': [{'measurements': [{'value': '14.53', 'spread': '3.85', 'groupId': 'OG000'}, {'value': '16.03', 'spread': '3.521', 'groupId': 'OG001'}]}]}, {'title': 'IL-4 (measurement unit: pg/ml)', 'categories': [{'measurements': [{'value': '109.1', 'spread': '8.944', 'groupId': 'OG000'}, {'value': '110.7', 'spread': '8.805', 'groupId': 'OG001'}]}]}, {'title': 'IL-17(measurement unit: pg/ml)', 'categories': [{'measurements': [{'value': '97.58', 'spread': '5.576', 'groupId': 'OG000'}, {'value': '95.34', 'spread': '3.982', 'groupId': 'OG001'}]}]}, {'title': 'IL-10 (measurement unit: pg/ml)', 'categories': [{'measurements': [{'value': '14.19', 'spread': '3.494', 'groupId': 'OG000'}, {'value': '15.86', 'spread': '3.847', 'groupId': 'OG001'}]}]}, {'title': 'PTX3 (measurement unit: pg/ml)', 'categories': [{'measurements': [{'value': '410.7', 'spread': '46.34', 'groupId': 'OG000'}, {'value': '415.6', 'spread': '52.73', 'groupId': 'OG001'}]}]}, {'title': 'NO concentration (measurement unit: pg/ml)', 'categories': [{'measurements': [{'value': '2.401', 'spread': '1.140', 'groupId': 'OG000'}, {'value': '2.380', 'spread': '1.233', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (T0)', 'description': 'At the time of enrollment (T0) concentrations of serum biomarkers (pg/ml) (IFN-γ, IL-17, IL-4, IL-10, PTX3 and NO) will be evaluated in patients of which, one group (A) will assume polyphenols (NATUR-OX ) while the other group (B) will assume placebo. Of note, from each group 7 spontaneously dropouts occurred. An ELISA method will be use to analyze and to assess serum biomarker concentrations.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NATUR-OX Group (A)', 'description': 'Administration, for three months (T1), of NATUR-OX® capsule/day. NATUR-OX® which is a dietary supplement containing grape seed extracts from Nero di Troia (Vitis vinifera). Each capsule contains 280 mg of proanthocyanidins where Ni contamination of capsule is below 0.24 ppm\n\nNaturOx Group (A): Comparison between dietary supplement and placebo'}, {'id': 'OG001', 'title': 'Placebo Group (B)', 'description': 'Administration with placebo one capsule/daily for three months. The placebo capsules had the same appearance and composition of the supplement except for the active ingredient (polyphenols)\n\nPlacebo Group (B): Comparison between dietary supplement and placebo'}], 'classes': [{'title': 'IFN-γ (measurement unit: pg/ml)', 'categories': [{'measurements': [{'value': '10.41', 'spread': '3.964', 'groupId': 'OG000'}, {'value': '17.29', 'spread': '3.687', 'groupId': 'OG001'}]}]}, {'title': 'IL-4 (measurement unit: pg/ml)', 'categories': [{'measurements': [{'value': '79.57', 'spread': '8.770', 'groupId': 'OG000'}, {'value': '112.2', 'spread': '8.840', 'groupId': 'OG001'}]}]}, {'title': 'IL-17 (measurement unit: pg/ml)', 'categories': [{'measurements': [{'value': '51.36', 'spread': '5.374', 'groupId': 'OG000'}, {'value': '100.6', 'spread': '4.519', 'groupId': 'OG001'}]}]}, {'title': 'IL-10 (measurement unit: pg/ml)', 'categories': [{'measurements': [{'value': '25.67', 'spread': '5.586', 'groupId': 'OG000'}, {'value': '11.19', 'spread': '2.737', 'groupId': 'OG001'}]}]}, {'title': 'PTX3 (measurement unit: pg/ml)', 'categories': [{'measurements': [{'value': '365.3', 'spread': '46.08', 'groupId': 'OG000'}, {'value': '455.9', 'spread': '50.05', 'groupId': 'OG001'}]}]}, {'title': 'NO concentration (measurement unit: pg/ml)', 'categories': [{'measurements': [{'value': '1.381', 'spread': '0.7823', 'groupId': 'OG000'}, {'value': '2.619', 'spread': '1.262', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 3 months (T1)', 'description': 'Serum biomarkers (IFN-γ, IL-17, IL-4, IL-10, PTX3 and NO) (pg/ml) in the same patients of both groups A and B whose received for 3 months Polyphenols (NATUR-OX) and placebo, respectively, were evaluated. To analyze serum biomarkers an ELISA method were used .', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NATUR-OX Group (A)', 'description': 'Administration, for three months (T1), of NATUR-OX® capsule/day. NATUR-OX® which is a dietary supplement containing grape seed extracts from Nero di Troia (Vitis vinifera). Each capsule contains 280 mg of proanthocyanidins where Ni contamination of capsule is below 0.24 ppm\n\nNaturOx Group (A): Comparison between dietary supplement and placebo'}, {'id': 'FG001', 'title': 'Placebo Group (B)', 'description': 'Administration with placebo one capsule/daily for three months. The placebo capsules had the same appearance and composition of the supplement except for the active ingredient (polyphenols)\n\nPlacebo Group (B): Comparison between dietary supplement and placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NATUR-OX Group (A)', 'description': 'Administration, for three months (T1), of NATUR-OX® capsule/day. NATUR-OX® which is a dietary supplement containing grape seed extracts from Nero di Troia (Vitis vinifera). Each capsule contains 280 mg of proanthocyanidins where Ni contamination of capsule is below 0.24 ppm\n\nNaturOx Group (A): Comparison between dietary supplement and placebo'}, {'id': 'BG001', 'title': 'Placebo Group (B)', 'description': 'Administration with placebo one capsule/daily for three months. The placebo capsules had the same appearance and composition of the supplement except for the active ingredient (polyphenols)\n\nPlacebo Group (B): Comparison between dietary supplement and placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Eighteen patients received NATUR-OX (age range 28-59). Eighteen patients received placebo (age range 25-60).', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.7', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '59'}, {'value': '42.5', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '60'}, {'value': '42.5', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '60'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of patients enrolled who are Italian.', 'unitOfMeasure': 'Participants'}, {'title': 'Evaluation of IFN-γ at T0', 'classes': [{'categories': [{'measurements': [{'value': '14.53', 'spread': '3.85', 'groupId': 'BG000'}, {'value': '16.03', 'spread': '3.521', 'groupId': 'BG001'}, {'value': '15.28', 'spread': '3.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Twenty-five patients were enrolled, and they were administered with polyphenols (NATUR-OX (A), instead other 25 patients were enrolled to assume placebo (B). From each group 7 dropouts occurred.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Evaluation of IL-17 at T0', 'classes': [{'categories': [{'measurements': [{'value': '97.58', 'spread': '5.576', 'groupId': 'BG000'}, {'value': '95.34', 'spread': '3.982', 'groupId': 'BG001'}, {'value': '96.46', 'spread': '4.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Evaluation of IL-4 at T0', 'classes': [{'categories': [{'measurements': [{'value': '109.1', 'spread': '8.944', 'groupId': 'BG000'}, {'value': '110.7', 'spread': '8.805', 'groupId': 'BG001'}, {'value': '109.87', 'spread': '8.78', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Evaluation of IL-10 at T0', 'classes': [{'categories': [{'measurements': [{'value': '14.19', 'spread': '3.494', 'groupId': 'BG000'}, {'value': '15.86', 'spread': '3.847', 'groupId': 'BG001'}, {'value': '15.03', 'spread': '3.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Evaluation of PTX3 at T0', 'classes': [{'categories': [{'measurements': [{'value': '410.7', 'spread': '46.34', 'groupId': 'BG000'}, {'value': '415.6', 'spread': '52.73', 'groupId': 'BG001'}, {'value': '413.11', 'spread': '48.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Evaluation of No concentrations at T0', 'classes': [{'categories': [{'measurements': [{'value': '2.401', 'spread': '1.140', 'groupId': 'BG000'}, {'value': '2.380', 'spread': '1.233', 'groupId': 'BG001'}, {'value': '2.39', 'spread': '1.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': '7 dropouts for each group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-31', 'size': 99608, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-03-05T09:32', 'hasProtocol': True}, {'date': '2018-10-31', 'size': 58669, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-11T06:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-10', 'studyFirstSubmitDate': '2019-02-14', 'resultsFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2019-04-01', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-10', 'studyFirstPostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0)', 'timeFrame': 'Baseline (T0)', 'description': 'At the time of enrollment (T0) concentrations of serum biomarkers (pg/ml) (IFN-γ, IL-17, IL-4, IL-10, PTX3 and NO) will be evaluated in patients of which, one group (A) will assume polyphenols (NATUR-OX ) while the other group (B) will assume placebo. Of note, from each group 7 spontaneously dropouts occurred. An ELISA method will be use to analyze and to assess serum biomarker concentrations.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1)', 'timeFrame': 'After 3 months (T1)', 'description': 'Serum biomarkers (IFN-γ, IL-17, IL-4, IL-10, PTX3 and NO) (pg/ml) in the same patients of both groups A and B whose received for 3 months Polyphenols (NATUR-OX) and placebo, respectively, were evaluated. To analyze serum biomarkers an ELISA method were used .'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allergic contact dermatitis', 'Cytokines', 'Cellular and molecular rehabilitation', 'Immune response', 'Nickel', 'Polyphenols'], 'conditions': ['Allergic Contact Dermatitis']}, 'referencesModule': {'references': [{'pmid': '28982342', 'type': 'RESULT', 'citation': 'Magrone T, Romita P, Verni P, Salvatore R, Spagnoletta A, Magrone M, Russo MA, Jirillo E, Foti C. In vitro Effects of Polyphenols on the Peripheral Immune Responses in Nickel-sensitized Patients. Endocr Metab Immune Disord Drug Targets. 2017 Nov 16;17(4):324-331. doi: 10.2174/1871530317666171003161314.'}, {'pmid': '26179009', 'type': 'RESULT', 'citation': 'Johansen JD, Aalto-Korte K, Agner T, Andersen KE, Bircher A, Bruze M, Cannavo A, Gimenez-Arnau A, Goncalo M, Goossens A, John SM, Liden C, Lindberg M, Mahler V, Matura M, Rustemeyer T, Serup J, Spiewak R, Thyssen JP, Vigan M, White IR, Wilkinson M, Uter W. European Society of Contact Dermatitis guideline for diagnostic patch testing - recommendations on best practice. Contact Dermatitis. 2015 Oct;73(4):195-221. doi: 10.1111/cod.12432. Epub 2015 Jul 14.'}, {'pmid': '29524267', 'type': 'RESULT', 'citation': 'Summer B, Stander S, Thomas P. Cytokine patterns in vitro, in particular IL-5/IL-8 ratio, to detect patients with nickel contact allergy. J Eur Acad Dermatol Venereol. 2018 Sep;32(9):1542-1548. doi: 10.1111/jdv.14931. Epub 2018 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'Nickel (Ni)-mediated allergic contact dermatitis (ACD) is a very common disease worldwide. Our previous findings demonstrated that in vitro supplementation of polyphenols, extracted from seeds of red grape (Nero di Troia cultivar), to peripheral lymphomonocytes from Ni-mediated ACD patients could reduce release of T helper (h)1 \\[interferon (IFN)-\\] and Th2 \\[interleukin (IL)-4\\] cytokines, on the one hand. On the other hand, IL-10 (an anti-inflammatory cytokine) levels increased with a reduction of IL-17 (an inflammatory cytokine). Also levels of nitric oxide (NO) decreased in response to polyphenol pretreatment.', 'detailedDescription': 'Nickel (Ni) is a transitional metal largely distributed in the environment whose continuous exposure is able to provoke local and systemic allergic contact dermatitis (ACD). Ni-mediated ACD is characterized by loss of epidermal integrity, urticaria/angioedema, flares, and itching, whose extent depends on many variables such as genetic, time of sensitization and environmental exposure.The aim of the present research is to verify whether the oral administration of polyphenols (NATUR-OX®) to patients with Ni-mediated ACD is able to modify immune parameters.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patient; Age: 25-60 Years; Ni-mediated ACD (positive reaction to the nickel patch test)\n\nExclusion Criteria:\n\n* Absence of other pathologies such as immune-mediated diseases, metabolic diseases (diabetes and obesity)\n* infectious episodes in the last month and intake of immunosuppressive drugs or drugs influencing the immune response.'}, 'identificationModule': {'nctId': 'NCT03902392', 'acronym': 'Grapolyphen', 'briefTitle': 'Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Bari'}, 'officialTitle': 'Oral Human Administration of Red Grape Polyphenol in Nickel-mediated Allergic Contact Dermatitis: an in Vitro Study', 'orgStudyIdInfo': {'id': '5480'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NATUR-OX Group (A)', 'description': 'Administration, for three months (T1), of NATUR-OX® capsule/day. NATUR-OX® which is a dietary supplement containing grape seed extracts from Nero di Troia (Vitis vinifera). Each capsule contains 280 mg of proanthocyanidins where Ni contamination of capsule is below 0.24 ppm', 'interventionNames': ['Dietary Supplement: NaturOx Group (A)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group (B)', 'description': 'Administration with placebo one capsule/daily for three months. The placebo capsules had the same appearance and composition of the supplement except for the active ingredient (polyphenols)', 'interventionNames': ['Other: Placebo Group (B)']}], 'interventions': [{'name': 'NaturOx Group (A)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Comparison between dietary supplement and placebo', 'armGroupLabels': ['NATUR-OX Group (A)']}, {'name': 'Placebo Group (B)', 'type': 'OTHER', 'description': 'Comparison between dietary supplement and placebo', 'armGroupLabels': ['Placebo Group (B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Thea Magrone', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}], 'overallOfficials': [{'name': 'Caterina CF Foti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bari'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Aggregate Professor of Immunology', 'investigatorFullName': 'Thea Magrone', 'investigatorAffiliation': 'University of Bari'}}}}