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

Allergic Contact Dermatitis Clinical Trial

— Grapolyphen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902392
• Other study ID #: 5480
• Status: Completed
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: December 2019
• Source: University of Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 31, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Contact Dermatitis
• Dermatitis
• Dermatitis, Allergic Contact
• Dermatitis, Contact

Intervention

Dietary Supplement:
• NaturOx Group (A)
Comparison between dietary supplement and placebo

Other:
• Placebo Group (B)
Comparison between dietary supplement and placebo

Locations

Country	Name	City	State
Italy	Thea Magrone	Bari

Sponsors (1)

Lead Sponsor	Collaborator
University of Bari

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Johansen JD, Aalto-Korte K, Agner T, Andersen KE, Bircher A, Bruze M, Cannavó A, Giménez-Arnau A, Gonçalo M, Goossens A, John SM, Lidén C, Lindberg M, Mahler V, Matura M, Rustemeyer T, Serup J, Spiewak R, Thyssen JP, Vigan M, White IR, Wilkinson M, Uter W — View 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): — View Citation

Summer B, Ständer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0)	At the time of enrollment (T0) concentrations of serum biomarkers (pg/ml) (IFN-?, 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	Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1)	Serum biomarkers (IFN-?, 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)