An interventional study of NaturOx Group (A) and Placebo Group (B) in Allergic Contact Dermatitis, sponsored by University of Bari. Completed at 1 site in Italy. Open to female participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-01-02.
Sponsored by University of Bari · Not applicable, Interventional, and Supportive care
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.
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.
1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.
This study's enrollment of 50 is below the median of 64 across 1,131 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →University of Bari is the lead sponsor of 75 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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
Comparison between dietary supplement and placebo
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.
Time frame: Baseline (T0)
Evaluation of Serum Biomarker Concentrations at the End of the Treatment (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 .
Time frame: After 3 months (T1)
| Milestone | NATUR-OX Group (A) | Placebo Group (B) |
|---|---|---|
| Started | 25 | 25 |
| Completed | 18 | 18 |
| Not completed | 7 | 7 |
| Withdrew: Lost to follow-up | 7 | 7 |
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.
| pg/ml | NATUR-OX Group (A) | Placebo Group (B) |
|---|---|---|
| IFN-γ (measurement unit: pg/ml) | 14.53 ± 3.85 | 16.03 ± 3.521 |
| IL-4 (measurement unit: pg/ml) | 109.1 ± 8.944 | 110.7 ± 8.805 |
| IL-17(measurement unit: pg/ml) | 97.58 ± 5.576 | 95.34 ± 3.982 |
| IL-10 (measurement unit: pg/ml) | 14.19 ± 3.494 | 15.86 ± 3.847 |
| PTX3 (measurement unit: pg/ml) | 410.7 ± 46.34 | 415.6 ± 52.73 |
| NO concentration (measurement unit: pg/ml) | 2.401 ± 1.140 | 2.380 ± 1.233 |
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 .
| pg/ml | NATUR-OX Group (A) | Placebo Group (B) |
|---|---|---|
| IFN-γ (measurement unit: pg/ml) | 10.41 ± 3.964 | 17.29 ± 3.687 |
| IL-4 (measurement unit: pg/ml) | 79.57 ± 8.770 | 112.2 ± 8.840 |
| IL-17 (measurement unit: pg/ml) | 51.36 ± 5.374 | 100.6 ± 4.519 |
| IL-10 (measurement unit: pg/ml) | 25.67 ± 5.586 | 11.19 ± 2.737 |
| PTX3 (measurement unit: pg/ml) | 365.3 ± 46.08 | 455.9 ± 50.05 |
| NO concentration (measurement unit: pg/ml) | 1.381 ± 0.7823 | 2.619 ± 1.262 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NATUR-OX Group (A) | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Placebo Group (B) | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
7 dropouts for each group.
| Age, Categorical(Participants) | NATUR-OX Group (A) | Placebo Group (B) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 18 | 36 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | NATUR-OX Group (A) | Placebo Group (B) | Total |
|---|---|---|---|
| Mean | 43.7 (28 to 59) | 42.5 (25 to 60) | 42.5 (25 to 60) |
| Sex: Female, Male(Participants) | NATUR-OX Group (A) | Placebo Group (B) | Total |
|---|---|---|---|
| Female | 18 | 18 | 36 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | NATUR-OX Group (A) | Placebo Group (B) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 18 | 18 | 36 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | NATUR-OX Group (A) | Placebo Group (B) | Total |
|---|---|---|---|
| Italy | 18 | 18 | 36 |
| Evaluation of IFN-γ at T0(pg/ml) | NATUR-OX Group (A) | Placebo Group (B) | Total |
|---|---|---|---|
| Mean | 14.53 ± 3.85 | 16.03 ± 3.521 | 15.28 ± 3.72 |
| Evaluation of IL-17 at T0(pg/ml) | NATUR-OX Group (A) | Placebo Group (B) | Total |
|---|---|---|---|
| Mean | 97.58 ± 5.576 | 95.34 ± 3.982 | 96.46 ± 4.91 |
| Evaluation of IL-4 at T0(pg/ml) | NATUR-OX Group (A) | Placebo Group (B) | Total |
|---|---|---|---|
| Mean | 109.1 ± 8.944 | 110.7 ± 8.805 | 109.87 ± 8.78 |
3 further baseline measures are reported on the registry.
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University of Bari