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NCT Number: NCT03902392

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

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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Key information

Conditions

Allergic Contact Dermatitis Dermatitis Dermatitis, Allergic Contact Dermatitis, Contact Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

25 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Thea Magrone

Bari, 70124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NaturOx Group (A)

Dietary Supplement

Comparison between dietary supplement and placebo

Placebo Group (B)

Other

Comparison between dietary supplement and placebo

Primary outcomes

  1. Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0)

    Time frame: 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 outcomes

  1. Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1)

    Time frame: 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 .

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

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

Acronym: Grapolyphen

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2019
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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