N/A N=50 Randomized Double-blind Supportive Care

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

Allergic Contact Dermatitis

Bottom Line

View on ClinicalTrials.gov: NCT03902392 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2020

Primary outcome: Primary: Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) — 14.53; 16.03; 109.1; 110.7 pg/ml

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: NaturOx Group (A) (Dietary_supplement); Placebo Group (B) (Other)
Age: Adult · 25+ yrs
Sex: Female
Sponsor: University of Bari
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0)	14.53; 16.03; 109.1; 110.7; 97.58; 95.34	—
SECONDARY Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1)	10.41; 17.29; 79.57; 112.2; 51.36; 100.6	—

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.

Eligibility Criteria

Inclusion Criteria

Female patient; Age: 25-60 Years; Ni-mediated ACD (positive reaction to the nickel patch test)

Exclusion Criteria

Absence of other pathologies such as immune-mediated diseases, metabolic diseases (diabetes and obesity)
infectious episodes in the last month and intake of immunosuppressive drugs or drugs influencing the immune response.

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Data sourced from ClinicalTrials.gov (NCT03902392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.