Trials / Completed
CompletedNCT03902392
Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis
Oral Human Administration of Red Grape Polyphenol in Nickel-mediated Allergic Contact Dermatitis: an in Vitro Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- University of Bari · Academic / Other
- Sex
- Female
- Age
- 25 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | NaturOx Group (A) | Comparison between dietary supplement and placebo |
| OTHER | Placebo Group (B) | Comparison between dietary supplement and placebo |
Timeline
- Start date
- 2018-04-16
- Primary completion
- 2018-09-10
- Completion
- 2018-10-31
- First posted
- 2019-04-04
- Last updated
- 2020-01-02
- Results posted
- 2020-01-02
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03902392. Inclusion in this directory is not an endorsement.