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

University of Bari

Status: Completed

Conditions: Allergic Contact Dermatitis

Treatments: Dietary Supplement: NaturOx Group (A); Other: Placebo Group (B)

Study type: Interventional

Funder types: Other

Identifiers

NCT03902392

5480

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

NATUR-OX Group (A)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: NaturOx Group (A)

Placebo Group (B)

Placebo Comparator group

Description:

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)

Treatment:

Other: Placebo Group (B)