Dietary Prevention of Photodamage in Skin With Grapes

The University of Alabama at Birmingham

Status: Completed

Conditions: Non-melanoma Skin Cancer

Treatments: Other: Reconstituted grape powder

Study type: Interventional

Funder types: Other

Identifiers

NCT02760160

F140627004

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Reconstituted grape powder

Other group

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.

Treatment:

Other: Reconstituted grape powder