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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral Human Administration of Red Grape Polyphenol in Nickel-mediated Allergic Contact Dermatitis: an in Vitro Study

Conditions
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Allergic Contact Dermatitis

Intervention / Treatment
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* Dietary Supplement: NaturOx Group (A)
* Other: Placebo Group (B)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NATUR-OX Group (A)<br>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 | Dietary Supplement: NaturOx Group (A)<br>* Comparison between dietary supplement and placebo<br>|
| Placebo Comparator: Placebo Group (B)<br>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) | Other: Placebo Group (B)<br>* Comparison between dietary supplement and placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (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. | Baseline (T0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Serum Biomarker Concentrations at the End of the Treatment (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 . | After 3 months (T1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic contact dermatitis, Cytokines, Cellular and molecular rehabilitation, Immune response, Nickel, Polyphenols