Allergic Contact Dermatitis
Conditions
Keywords
Allergic contact dermatitis, Cytokines, Cellular and molecular rehabilitation, Immune response, Nickel, Polyphenols
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.
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.
Interventions
DIETARY_SUPPLEMENTNaturOx Group (A)
Comparison between dietary supplement and placebo
OTHERPlacebo Group (B)
Comparison between dietary supplement and placebo
Sponsors
University of Bari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1) | 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 . |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
NaturOx Group (A): Comparison between dietary supplement and placebo | 18 |
| 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)
Placebo Group (B): Comparison between dietary supplement and placebo | 18 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 7 |
Baseline characteristics
| Characteristic | NATUR-OX Group (A) | Placebo Group (B) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 18 Participants | 36 Participants |
| Age, Continuous | 43.7 years | 42.5 years | 42.5 years |
| Evaluation of IFN-γ at T0 | 14.53 pg/ml STANDARD_DEVIATION 3.85 | 16.03 pg/ml STANDARD_DEVIATION 3.521 | 15.28 pg/ml STANDARD_DEVIATION 3.72 |
| Evaluation of IL-10 at T0 | 14.19 pg/ml STANDARD_DEVIATION 3.494 | 15.86 pg/ml STANDARD_DEVIATION 3.847 | 15.03 pg/ml STANDARD_DEVIATION 3.72 |
| Evaluation of IL-17 at T0 | 97.58 pg/ml STANDARD_DEVIATION 5.576 | 95.34 pg/ml STANDARD_DEVIATION 3.982 | 96.46 pg/ml STANDARD_DEVIATION 4.91 |
| Evaluation of IL-4 at T0 | 109.1 pg/ml STANDARD_DEVIATION 8.944 | 110.7 pg/ml STANDARD_DEVIATION 8.805 | 109.87 pg/ml STANDARD_DEVIATION 8.78 |
| Evaluation of No concentrations at T0 | 2.401 pg/ml STANDARD_DEVIATION 1.14 | 2.380 pg/ml STANDARD_DEVIATION 1.233 | 2.39 pg/ml STANDARD_DEVIATION 1.17 |
| Evaluation of PTX3 at T0 | 410.7 pg/ml STANDARD_DEVIATION 46.34 | 415.6 pg/ml STANDARD_DEVIATION 52.73 | 413.11 pg/ml STANDARD_DEVIATION 48.98 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 18 Participants | 36 Participants |
| Region of Enrollment Italy | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NATUR-OX Group (A) | Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) | IFN-γ (measurement unit: pg/ml) | 14.53 pg/ml | Standard Deviation 3.85 |
| NATUR-OX Group (A) | Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) | IL-4 (measurement unit: pg/ml) | 109.1 pg/ml | Standard Deviation 8.944 |
| NATUR-OX Group (A) | Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) | IL-17(measurement unit: pg/ml) | 97.58 pg/ml | Standard Deviation 5.576 |
| NATUR-OX Group (A) | Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) | IL-10 (measurement unit: pg/ml) | 14.19 pg/ml | Standard Deviation 3.494 |
| NATUR-OX Group (A) | Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) | PTX3 (measurement unit: pg/ml) | 410.7 pg/ml | Standard Deviation 46.34 |
| NATUR-OX Group (A) | Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) | NO concentration (measurement unit: pg/ml) | 2.401 pg/ml | Standard Deviation 1.14 |
| Placebo Group (B) | Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) | PTX3 (measurement unit: pg/ml) | 415.6 pg/ml | Standard Deviation 52.73 |
| Placebo Group (B) | Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) | IFN-γ (measurement unit: pg/ml) | 16.03 pg/ml | Standard Deviation 3.521 |
| Placebo Group (B) | Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) | IL-10 (measurement unit: pg/ml) | 15.86 pg/ml | Standard Deviation 3.847 |
| Placebo Group (B) | Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) | IL-4 (measurement unit: pg/ml) | 110.7 pg/ml | Standard Deviation 8.805 |
| Placebo Group (B) | Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) | NO concentration (measurement unit: pg/ml) | 2.380 pg/ml | Standard Deviation 1.233 |
| Placebo Group (B) | Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) | IL-17(measurement unit: pg/ml) | 95.34 pg/ml | Standard Deviation 3.982 |
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NATUR-OX Group (A) | Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1) | IFN-γ (measurement unit: pg/ml) | 10.41 pg/ml | Standard Deviation 3.964 |
| NATUR-OX Group (A) | Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1) | IL-4 (measurement unit: pg/ml) | 79.57 pg/ml | Standard Deviation 8.77 |
| NATUR-OX Group (A) | Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1) | IL-17 (measurement unit: pg/ml) | 51.36 pg/ml | Standard Deviation 5.374 |
| NATUR-OX Group (A) | Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1) | IL-10 (measurement unit: pg/ml) | 25.67 pg/ml | Standard Deviation 5.586 |
| NATUR-OX Group (A) | Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1) | PTX3 (measurement unit: pg/ml) | 365.3 pg/ml | Standard Deviation 46.08 |
| NATUR-OX Group (A) | Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1) | NO concentration (measurement unit: pg/ml) | 1.381 pg/ml | Standard Deviation 0.7823 |
| Placebo Group (B) | Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1) | PTX3 (measurement unit: pg/ml) | 455.9 pg/ml | Standard Deviation 50.05 |
| Placebo Group (B) | Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1) | IFN-γ (measurement unit: pg/ml) | 17.29 pg/ml | Standard Deviation 3.687 |
| Placebo Group (B) | Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1) | IL-10 (measurement unit: pg/ml) | 11.19 pg/ml | Standard Deviation 2.737 |
| Placebo Group (B) | Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1) | IL-4 (measurement unit: pg/ml) | 112.2 pg/ml | Standard Deviation 8.84 |
| Placebo Group (B) | Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1) | NO concentration (measurement unit: pg/ml) | 2.619 pg/ml | Standard Deviation 1.262 |
| Placebo Group (B) | Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1) | IL-17 (measurement unit: pg/ml) | 100.6 pg/ml | Standard Deviation 4.519 |