Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-28 @ 6:16 AM
Study NCT ID:
NCT06072066
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2023-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2023-10-02', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inflammatory lesions on the face', 'timeFrame': '4 weeks', 'description': 'Change in number of inflammatory lesions on the face'}, {'measure': 'Inflammatory lesions on the face', 'timeFrame': '8 weeks', 'description': 'Change in number of inflammatory lesions on the face'}, {'measure': 'Facial erythema', 'timeFrame': '4 weeks', 'description': 'Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System)'}, {'measure': 'Facial erythema', 'timeFrame': '8 weeks', 'description': 'Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System)'}], 'primaryOutcomes': [{'measure': 'Transepidermal water loss (TEWL)', 'timeFrame': '8 weeks', 'description': 'Change in the facial transepidermal water loss (TEWL) using the Vapometer.'}, {'measure': 'Blood hs-CRP level', 'timeFrame': '8 weeks', 'description': 'Change in blood hs-CRP level through blood spot testing'}], 'secondaryOutcomes': [{'measure': 'Intestinal permeability', 'timeFrame': '4 weeks', 'description': 'Change in intestinal permeability through a urine based test by Genova Diagnostics'}, {'measure': 'Intestinal permeability', 'timeFrame': '8 weeks', 'description': 'Change in intestinal permeability through a urine based test by Genova Diagnostics'}, {'measure': 'Fecal levels of calprotectin', 'timeFrame': '4 weeks', 'description': 'Change in fecal levels of calprotectin through a stool sample'}, {'measure': 'Fecal levels of calprotectin', 'timeFrame': '8 weeks', 'description': 'Change in fecal levels of calprotectin through a stool sample'}, {'measure': 'Transepidermal water loss (TEWL)', 'timeFrame': '4 weeks', 'description': 'Change in the facial transepidermal water loss (TEWL) using the Vapometer.'}, {'measure': 'Blood hs-CRP level', 'timeFrame': '4 weeks', 'description': 'Change in blood hs-CRP level through blood spot testing'}, {'measure': 'Mood Questionnaire', 'timeFrame': '4 weeks', 'description': 'A survey to assess changes in mood'}, {'measure': 'Mood Questionnaire', 'timeFrame': '8 Weeks', 'description': 'A survey to assess changes in mood'}, {'measure': 'Digestive Questionnaire', 'timeFrame': '4 weeks', 'description': 'A survey to assess digestive health'}, {'measure': 'Digestive Questionnaire', 'timeFrame': '8 weeks', 'description': 'A survey to assess digestive health'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rosacea', 'L-Histidine', 'Antioxidants'], 'conditions': ['Rosacea', 'Systemic Inflammation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.', 'detailedDescription': 'Rosacea is a chronic inflammatory condition that widely prevalent in the general population and is associated with both inflammation and dysfunction of the skin barrier. Gut dysfunction has been shown to be present in those with rosacea. This study evaluates how the use of a supplement may improve the gut and skin barrier as well as reduce general inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females 30 to 70 years of age\n* The presence of mild to moderate rosacea (erythematotelangiectatic or papulopustular)\n* High sensitivity C-reactive protein (hs-CRP) that is greater than or equal to 1.0 mg/L\n\nExclusion Criteria:\n\n* The presence of severe rosacea as noted by the investigator global assessment.\n* Those who are unwilling to discontinue oral supplementation, or supplement ingredients found in the study's oral product 1 month prior to enrollment.\n* Discontinuation of oral L-glutamine or L-glutamine containing supplement 1 month prior to enrollment\n* Those who are unwilling to discontinue topical benzoyl peroxide or retinoids for 2 weeks prior to enrollment.\n* Those who are unwilling to keep their facial regimen the same throughout the study.\n* Individuals who have been on an oral antibiotic within the previous one month.\n* Individuals who are pregnant or breastfeeding.\n* Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study.\n* Individuals on oral contraceptive pills or progesterone or estrogen containing therapies.\n* Use of isotretinoin within the three months prior to enrollment.\n* Individuals on finasteride or dutasteride\n* Current tobacco smoker, smoker within the past year, or greater than 5 pack-year tobacco smoking history."}, 'identificationModule': {'nctId': 'NCT06072066', 'briefTitle': 'Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integrative Skin Science and Research'}, 'officialTitle': 'The Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea', 'orgStudyIdInfo': {'id': 'i23-04_CL_SkinBarrier_Supp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Skin Barrier Oral Supplement', 'interventionNames': ['Dietary Supplement: Skin Barrier Oral Supplement']}], 'interventions': [{'name': 'Skin Barrier Oral Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplment powder', 'armGroupLabels': ['Skin Barrier Oral Supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Raja Sivamani, MD, MS, AP', 'role': 'CONTACT', 'email': 'research@integrativeskinresearch.com', 'phone': '916-750-2463'}, {'name': 'Raja Sivamani, MD MS AP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Integrative Skin and Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'centralContacts': [{'name': 'Caitlin Egli', 'role': 'CONTACT', 'email': 'research@integrativeskinresearch.com', 'phone': '916-750-2463'}, {'name': 'Milred Min', 'role': 'CONTACT', 'email': 'milred@integrativeskinresearch.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integrative Skin Science and Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}