Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-11 @ 7:35 AM
Study NCT ID:
NCT02760160
Status:
COMPLETED
Last Update Posted:
2019-03-08
First Post:
2015-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Prevention of Photodamage in Skin With Grapes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722782', 'term': 'whole grape extract'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-06', 'studyFirstSubmitDate': '2015-12-17', 'studyFirstSubmitQcDate': '2016-04-29', 'lastUpdatePostDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects reporting protective effect against sunburn response to UVG and/or UVA1 following administration of dietary grape powder.', 'timeFrame': '2 weeks', 'description': "Assessment will be quantified by evaluation of a person's minimal erythema dose (MED), the smallest amount of ultraviolet (UV) required to achieve a sunburn response. 6 small areas of skin (2 inches by 2 inches) on the inner part of a person's arm will be exposed to 6 separate but increasing doses of UV. 24 hours after UV treatment, the area that received the smallest dose of UV and has a visible area of redness will be marked and the respective UV dose will be considered the MED. A desirable outcome would be if an individual's MED goes up after 2 weeks of grape treatment."}], 'secondaryOutcomes': [{'measure': 'Measure whether dietary grape powder results in a significant (p<0.05 using parire ttest) % change in markers associated with NMSC as measured by it biomarker: ornithine decarboxylase (ODC)', 'timeFrame': '2 weeks', 'description': 'Immunohistochemistry (IHC) will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated.'}, {'measure': 'Measure whether dietary grape powder results in a significant (p<0.05 using parire ttest) % change in markers associated with NMSC as measured by it biomarker: proliferating cell nuclear antigen (PCNA)', 'timeFrame': '2 weeks', 'description': 'Immunohistochemistry (IHC) will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated'}, {'measure': 'Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Ki67', 'timeFrame': '2 weeks', 'description': 'IHC will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated'}, {'measure': 'Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Cyclin D1', 'timeFrame': '2 weeks', 'description': 'IHC will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated'}, {'measure': 'Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Cyclooxygenase-2 (COX-2)', 'timeFrame': '2 weeks', 'description': 'IHC will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated'}, {'measure': 'Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: matrix metalloproteinase-7 (MMP-7)', 'timeFrame': '2 weeks', 'description': 'IHC will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated.'}, {'measure': 'Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: matrix metalloproteinase-9 (MMP-9)', 'timeFrame': '2 weeks', 'description': 'IHC will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated'}, {'measure': 'Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Normal p53', 'timeFrame': '2 weeks', 'description': 'IHC will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated.'}, {'measure': 'Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Mutant p53', 'timeFrame': '2 weeks', 'description': 'IHC will be used to quantify the percentage of stained cells using the microscope. This percentage will be compared in biopsy samples before and after grape treatment for each individual. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of stained cells)/(total number of patients). Furthermore, western blot will be used to quantify the level of protein expression. The expression of each marker will be compared in each patient and the aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in expression of the respective biomarker)/(total number of patients). The percent change of each biomarker expression before and after treatment if a notable difference is observed using either IHC or western blot, or both will be calculated.'}, {'measure': 'Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Sunburnt cells', 'timeFrame': '2 weeks', 'description': 'Routine histology (hematoxylin and eosin stain) will be used and the number of sunburnt cells will be quantified under the microscope. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of sunburnt cells)/(total number of patients). We will also calculate the change in the number of sunburnt cells before and after treatment if a notable difference is observed.'}, {'measure': 'Determine whether dietary grape powder has photoprotective activities resulting in a significant change in biomarkers associated with NMSC: by biomarker: Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL)-positive cells', 'timeFrame': '2 weeks', 'description': 'The number of TUNEL-positive cells, which will be fluorescent, will be quantified under the microscope. The aggregate data will be presented using the following formula: (number of patients with a statistically significant decrease in the percentage of TUNEL-positive cells)/(total number of patients). We will also calculate the percent change TUNEL-positive cells before and after treatment if a notable difference is observed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-melanoma Skin Cancer']}, 'descriptionModule': {'briefSummary': 'To assess the effect of orally administered grape powder on the sunburn reaction in humans.', 'detailedDescription': 'To determine whether oral grape powder will result in a reduction in biomarkers associated with basal cell carcinomas (BCCs) and squamous cell carcinomas (SCCs). Biomarkers taken from non-sun-exposed skin and UV-exposed skin before and after treatment will be compared.\n\nThe ultimate goal of this study will be to generate new knowledge of the photoprotective effect of grape powder on UV exposure. The results may be employed as the basis for a larger clinical trial to evaluate the potential of grapes to prevent non-melanoma skin cancers (NMSCs) and sun damage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age 18 and older\n* Patient able to understand requirements of the study and risks involved\n* Patient able to sign a consent form\n\nExclusion Criteria:\n\n* Patients Fitzpatrick IV-VI\n* A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation\n* A known history of photosensitivity disorders\n* A known history of melanoma or non-melanoma skin cancers\n* Those planning on going to the tanning parlors\n* Using any of the photosensitizing medication\n* A woman who is lactating, pregnant, or planning to become pregnant\n* Patient planning on exposing the irradiated or control areas to the sun'}, 'identificationModule': {'nctId': 'NCT02760160', 'briefTitle': 'Dietary Prevention of Photodamage in Skin With Grapes', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Dietary Prevention of Photodamage in Skin With Grapes: A Human Clinical Study', 'orgStudyIdInfo': {'id': 'F140627004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Reconstituted grape powder', 'description': 'Open grape powder pouch and pour contents into volumetric measuring device. Add approximately 180 mL of water to container with grape powder. Stir for a minimum of 30 seconds and ingest.', 'interventionNames': ['Other: Reconstituted grape powder']}], 'interventions': [{'name': 'Reconstituted grape powder', 'type': 'OTHER', 'otherNames': ['Grape powder'], 'description': "To prevent UV-induced skin cancers. Each subject's will have one arm exposed to 6 separate doses of UV (J/m2) \\[114, 217, 343, 500, 619, 848\\].", 'armGroupLabels': ['Reconstituted grape powder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Dermatology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Craig A. Elmets, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Craig Elmets', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}