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

Not Applicable

Completed

Interventions: Other: Placebo Group (B)
Dietary Supplement: NaturOx Group (A)

Brief 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.

Detailed Description: Nickel (Ni) is a transitional metal largely distributed in the environment whose continuous exposure is able to provoke local and systemic allergic contact dermatitis (ACD). Ni-mediated ACD is characterized by loss of epidermal integrity, urticaria/angioedema, flares, and itching, whose extent depends on many variables such as genetic, time of sensitization and environmental exposure.The aim of the present research is to verify whether the oral administration of polyphenols (NATUR-OX®) to patients with Ni-mediated ACD is able to modify immune parameters.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo Group (B)	Placebo Group (B)	Administration with placebo one capsule/daily for three months. The placebo capsules had the same appearance and composition of the supplement except for the active ingredient (polyphenols)
NATUR-OX Group (A)	NaturOx Group (A)	Administration, for three months (T1), of NATUR-OX® capsule/day. NATUR-OX® which is a dietary supplement containing grape seed extracts from Nero di Troia (Vitis vinifera). Each capsule contains 280 mg of proanthocyanidins where Ni contamination of capsule is below 0.24 ppm

Primary Outcome Measures

Name	Time	Method
Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0)	Baseline (T0)	At the time of enrollment (T0) concentrations of serum biomarkers (pg/ml) (IFN-γ, IL-17, IL-4, IL-10, PTX3 and NO) will be evaluated in patients of which, one group (A) will assume polyphenols (NATUR-OX ) while the other group (B) will assume placebo. Of note, from each group 7 spontaneously dropouts occurred. An ELISA method will be use to analyze and to assess serum biomarker concentrations.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1)	After 3 months (T1)	Serum biomarkers (IFN-γ, IL-17, IL-4, IL-10, PTX3 and NO) (pg/ml) in the same patients of both groups A and B whose received for 3 months Polyphenols (NATUR-OX) and placebo, respectively, were evaluated. To analyze serum biomarkers an ELISA method were used .