Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis

NCT03902392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-01-02

Study results available
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Summary

Nickel (Ni)-mediated allergic contact dermatitis (ACD) is a very common disease worldwide. Our previous findings demonstrated that in vitro supplementation of polyphenols, extracted from seeds of red grape (Nero di Troia cultivar), to peripheral lymphomonocytes from Ni-mediated ACD patients could reduce release of T helper (h)1 \[interferon (IFN)-\] and Th2 \[interleukin (IL)-4\] cytokines, on the one hand. On the other hand, IL-10 (an anti-inflammatory cytokine) levels increased with a reduction of IL-17 (an inflammatory cytokine). Also levels of nitric oxide (NO) decreased in response to polyphenol pretreatment.

Conditions

  • Allergic Contact Dermatitis

Interventions

DIETARY_SUPPLEMENT

NaturOx Group (A)

Comparison between dietary supplement and placebo

OTHER

Placebo Group (B)

Comparison between dietary supplement and placebo

Sponsors & Collaborators

  • University of Bari

    lead OTHER

Principal Investigators

  • Caterina CF Foti, MD · University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2018-09-10
Completion
2018-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03902392 on ClinicalTrials.gov