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Trial record 1 of 1 for:    Dietary Prevention of Photodamage in Skin With Grapes
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Dietary Prevention of Photodamage in Skin With Grapes

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ClinicalTrials.gov Identifier: NCT02760160
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Craig Elmets, University of Alabama at Birmingham

Brief Summary:
To assess the effect of orally administered grape powder on the sunburn reaction in humans.

Condition or disease Intervention/treatment Phase
Non-melanoma Skin Cancer Other: Reconstituted grape powder Not Applicable

Detailed Description:

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.

The 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dietary Prevention of Photodamage in Skin With Grapes: A Human Clinical Study
Study Start Date : October 2015
Actual Primary Completion Date : September 27, 2018
Actual Study Completion Date : September 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sun Exposure

Arm Intervention/treatment
Reconstituted grape powder
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.
Other: Reconstituted grape powder
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].
Other Name: Grape powder




Primary Outcome Measures :
  1. Number of subjects reporting protective effect against sunburn response to UVG and/or UVA1 following administration of dietary grape powder. [ Time Frame: 2 weeks ]
    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.


Secondary Outcome Measures :
  1. 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) [ Time Frame: 2 weeks ]
    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.

  2. 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) [ Time Frame: 2 weeks ]
    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

  3. 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 [ Time Frame: 2 weeks ]
    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

  4. 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 [ Time Frame: 2 weeks ]
    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

  5. 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) [ Time Frame: 2 weeks ]
    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

  6. 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) [ Time Frame: 2 weeks ]
    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.

  7. 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) [ Time Frame: 2 weeks ]
    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

  8. 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 [ Time Frame: 2 weeks ]
    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.

  9. 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 [ Time Frame: 2 weeks ]
    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.

  10. 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 [ Time Frame: 2 weeks ]
    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.

  11. 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 [ Time Frame: 2 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient age 18 and older
  • Patient able to understand requirements of the study and risks involved
  • Patient able to sign a consent form

Exclusion Criteria:

  • Patients Fitzpatrick IV-VI
  • A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
  • A known history of photosensitivity disorders
  • A known history of melanoma or non-melanoma skin cancers
  • Those planning on going to the tanning parlors
  • Using any of the photosensitizing medication
  • A woman who is lactating, pregnant, or planning to become pregnant
  • Patient planning on exposing the irradiated or control areas to the sun

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760160


Locations
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United States, Alabama
UAB Dermatology
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Craig A. Elmets, MD University of Alabama at Birmingham
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Responsible Party: Craig Elmets, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02760160    
Other Study ID Numbers: F140627004
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: January 2018
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases