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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2018-10-31

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.

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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.

Conditions

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Allergic Contact Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NATUR-OX 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

Group Type ACTIVE_COMPARATOR

NaturOx Group (A)

Intervention Type DIETARY_SUPPLEMENT

Comparison between dietary supplement and placebo

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)

Group Type PLACEBO_COMPARATOR

Placebo Group (B)

Intervention Type OTHER

Comparison between dietary supplement and placebo

Interventions

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NaturOx Group (A)

Comparison between dietary supplement and placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo Group (B)

Comparison between dietary supplement and placebo

Intervention Type OTHER

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No