NCT02760160

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2018

Completed
Last Updated

March 8, 2019

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

December 17, 2015

Last Update Submit

March 6, 2019

Conditions

Non-melanoma Skin Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of subjects reporting protective effect against sunburn response to UVG and/or UVA1 following administration of dietary grape powder.

    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.

    2 weeks

Secondary Outcomes (11)

  • 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)

    2 weeks

  • 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)

    2 weeks

  • 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

    2 weeks

  • 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

    2 weeks

  • 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)

    2 weeks

  • +6 more secondary outcomes

Study Arms (1)

Reconstituted grape powder

OTHER

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

Interventions

Reconstituted grape powderOTHER

To prevent UV-induced skin cancers. Each subject's will have one arm exposed to 6 separate doses of UV (J/m2) \[114, 217, 343, 500, 619, 848\].

Also known as: Grape powder
Reconstituted grape powder

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Dermatology

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Interventions

whole grape extract

Study Officials

  • Craig A. Elmets, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 17, 2015

First Posted

May 3, 2016

Study Start

October 1, 2015

Primary Completion

September 27, 2018

Study Completion

September 27, 2018

Last Updated

March 8, 2019

Record last verified: 2018-01

Locations

US(1)