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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902392
Recruitment Status : Completed
First Posted : April 4, 2019
Results First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Thea Magrone, University of Bari

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.

Condition or disease Intervention/treatment Phase
Allergic Contact Dermatitis Dietary Supplement: NaturOx Group (A) Other: Placebo Group (B) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Oral Human Administration of Red Grape Polyphenol in Nickel-mediated Allergic Contact Dermatitis: an in Vitro Study
Actual Study Start Date : April 16, 2018
Actual Primary Completion Date : September 10, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Nickel

Arm Intervention/treatment
Active Comparator: NATUR-OX Group (A)
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)
Comparison between dietary supplement and placebo

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 .



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902392


Locations
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Italy
Thea Magrone
Bari, Italy, 70124
Sponsors and Collaborators
University of Bari
Investigators
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Principal Investigator: Caterina CF Foti, MD University of Bari
  Study Documents (Full-Text)

Documents provided by Thea Magrone, University of Bari:
Study Protocol  [PDF] October 31, 2018
Statistical Analysis Plan  [PDF] October 31, 2018

Publications of Results:
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Responsible Party: Thea Magrone, Aggregate Professor of Immunology, University of Bari
ClinicalTrials.gov Identifier: NCT03902392    
Other Study ID Numbers: 5480
First Posted: April 4, 2019    Key Record Dates
Results First Posted: January 2, 2020
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thea Magrone, University of Bari:
Allergic contact dermatitis
Cytokines
Cellular and molecular rehabilitation
Immune response
Nickel
Polyphenols
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Contact
Dermatitis, Allergic Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases