Clinical trial NCT03902392: Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis
Official title: Oral Human Administration of Red Grape Polyphenol in Nickel-mediated Allergic Contact Dermatitis: an in Vitro Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Contact Dermatitis
Keywords: Allergic contact dermatitis
Cytokines
Cellular and molecular rehabilitation
Immune response
Nickel
Polyphenols
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0)
timeFrame: Baseline (T0)
Secondary outcomes:
measure: Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1)
timeFrame: After 3 months (T1)
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Thea Magrone
Study officials:
affiliation: University of Bari
name: Caterina CF Foti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Magrone T, Romita P, Verni P, Salvatore R, Spagnoletta A, Magrone M, Russo MA, Jirillo E, Foti C. In vitro Effects of Polyphenols on the Peripheral Immune Responses in Nickel-sensitized Patients. Endocr Metab Immune Disord Drug Targets. 2017 Nov 16;17(4):324-331. doi: 10.2174/1871530317666171003161314.
citation: Johansen JD, Aalto-Korte K, Agner T, Andersen KE, Bircher A, Bruze M, Cannavo A, Gimenez-Arnau A, Goncalo M, Goossens A, John SM, Liden C, Lindberg M, Mahler V, Matura M, Rustemeyer T, Serup J, Spiewak R, Thyssen JP, Vigan M, White IR, Wilkinson M, Uter W. European Society of Contact Dermatitis guideline for diagnostic patch testing - recommendations on best practice. Contact Dermatitis. 2015 Oct;73(4):195-221. doi: 10.1111/cod.12432. Epub 2015 Jul 14.
citation: Summer B, Stander S, Thomas P. Cytokine patterns in vitro, in particular IL-5/IL-8 ratio, to detect patients with nickel contact allergy. J Eur Acad Dermatol Venereol. 2018 Sep;32(9):1542-1548. doi: 10.1111/jdv.14931. Epub 2018 Mar 26.