N/A
Completed N=50
Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis
Source: ClinicalTrials.gov NCT03902392 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) — 14.53; 16.03; 109.1; 110.7 pg/ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) |
14.53; 16.03; 109.1; 110.7; 97.58; 95.34 | — |
| SECONDARY Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1) |
10.41; 17.29; 79.57; 112.2; 51.36; 100.6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03902392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.