Adults 25 to 60, female only, with Allergic Contact Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0)Primary· 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.
IFN-γ (measurement unit: pg/ml)
Group
Value
95% CI
NATUR-OX Group (A)
14.53
± 3.85
Placebo Group (B)
16.03
± 3.521
IL-4 (measurement unit: pg/ml)
Group
Value
95% CI
NATUR-OX Group (A)
109.1
± 8.944
Placebo Group (B)
110.7
± 8.805
IL-17(measurement unit: pg/ml)
Group
Value
95% CI
NATUR-OX Group (A)
97.58
± 5.576
Placebo Group (B)
95.34
± 3.982
IL-10 (measurement unit: pg/ml)
Group
Value
95% CI
NATUR-OX Group (A)
14.19
± 3.494
Placebo Group (B)
15.86
± 3.847
PTX3 (measurement unit: pg/ml)
Group
Value
95% CI
NATUR-OX Group (A)
410.7
± 46.34
Placebo Group (B)
415.6
± 52.73
NO concentration (measurement unit: pg/ml)
Group
Value
95% CI
NATUR-OX Group (A)
2.401
± 1.140
Placebo Group (B)
2.380
± 1.233
Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1)Secondary· 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 .
IFN-γ (measurement unit: pg/ml)
Group
Value
95% CI
NATUR-OX Group (A)
10.41
± 3.964
Placebo Group (B)
17.29
± 3.687
IL-4 (measurement unit: pg/ml)
Group
Value
95% CI
NATUR-OX Group (A)
79.57
± 8.770
Placebo Group (B)
112.2
± 8.840
IL-17 (measurement unit: pg/ml)
Group
Value
95% CI
NATUR-OX Group (A)
51.36
± 5.374
Placebo Group (B)
100.6
± 4.519
IL-10 (measurement unit: pg/ml)
Group
Value
95% CI
NATUR-OX Group (A)
25.67
± 5.586
Placebo Group (B)
11.19
± 2.737
PTX3 (measurement unit: pg/ml)
Group
Value
95% CI
NATUR-OX Group (A)
365.3
± 46.08
Placebo Group (B)
455.9
± 50.05
NO concentration (measurement unit: pg/ml)
Group
Value
95% CI
NATUR-OX Group (A)
1.381
± 0.7823
Placebo Group (B)
2.619
± 1.262
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Bari
Last refreshed: 2 January 2020
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