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

NCT03902392 | Completed Results DMC

• 1 other identifier: 5480
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Contact Dermatitis

Keywords

Allergic contact dermatitis; Cytokines; Cellular and molecular rehabilitation; Immune response; Nickel; Polyphenols

Outcome Measures

Primary Outcomes (1)

• Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (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.

  Baseline (T0)

Secondary Outcomes (1)

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

  After 3 months (T1)

Study Arms (2)

NATUR-OX Group (A)

ACTIVE COMPARATOR

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

Dietary Supplement: NaturOx Group (A)

Placebo Group (B)

PLACEBO COMPARATOR

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)

Other: Placebo Group (B)

Interventions

NaturOx Group (A) DIETARY_SUPPLEMENT

Comparison between dietary supplement and placebo

NATUR-OX Group (A)

Placebo Group (B) OTHER

Comparison between dietary supplement and placebo

Placebo Group (B)

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patient; Age: 25-60 Years; Ni-mediated ACD (positive reaction to the nickel patch test)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Thea Magrone

Bari, 70124, Italy

Location

Related Publications (3)

• 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.

  PMID: 28982342 RESULT

• 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.

  PMID: 26179009 RESULT

• 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.

  PMID: 29524267 RESULT

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Thea TM Magrone, BD
• Organization: University of Bari

thea.magrone@uniba.it

+39 080 5478584

Study Officials

• Caterina CF Foti, MD

  University of Bari

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aggregate Professor of Immunology

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: April 4, 2019
• Study Start: April 16, 2018
• Primary Completion: September 10, 2018
• Study Completion: October 31, 2018
• Last Updated: January 2, 2020
• Results First Posted: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)