Trial Outcomes & Findings for Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis (NCT NCT03902392)
NCT ID: NCT03902392
Last Updated: 2020-01-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline (T0)
Results posted on
2020-01-02
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
Baseline Characteristics
Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis
Baseline characteristics by cohort
| Measure |
NATUR-OX Group (A)
n=18 Participants
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
|
Placebo Group (B)
n=18 Participants
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
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.7 years
n=5 Participants
|
42.5 years
n=7 Participants
|
42.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Evaluation of IFN-γ at T0
|
14.53 pg/ml
STANDARD_DEVIATION 3.85 • n=5 Participants
|
16.03 pg/ml
STANDARD_DEVIATION 3.521 • n=7 Participants
|
15.28 pg/ml
STANDARD_DEVIATION 3.72 • n=5 Participants
|
|
Evaluation of IL-17 at T0
|
97.58 pg/ml
STANDARD_DEVIATION 5.576 • n=5 Participants
|
95.34 pg/ml
STANDARD_DEVIATION 3.982 • n=7 Participants
|
96.46 pg/ml
STANDARD_DEVIATION 4.91 • n=5 Participants
|
|
Evaluation of IL-4 at T0
|
109.1 pg/ml
STANDARD_DEVIATION 8.944 • n=5 Participants
|
110.7 pg/ml
STANDARD_DEVIATION 8.805 • n=7 Participants
|
109.87 pg/ml
STANDARD_DEVIATION 8.78 • n=5 Participants
|
|
Evaluation of IL-10 at T0
|
14.19 pg/ml
STANDARD_DEVIATION 3.494 • n=5 Participants
|
15.86 pg/ml
STANDARD_DEVIATION 3.847 • n=7 Participants
|
15.03 pg/ml
STANDARD_DEVIATION 3.72 • n=5 Participants
|
|
Evaluation of PTX3 at T0
|
410.7 pg/ml
STANDARD_DEVIATION 46.34 • n=5 Participants
|
415.6 pg/ml
STANDARD_DEVIATION 52.73 • n=7 Participants
|
413.11 pg/ml
STANDARD_DEVIATION 48.98 • n=5 Participants
|
|
Evaluation of No concentrations at T0
|
2.401 pg/ml
STANDARD_DEVIATION 1.140 • n=5 Participants
|
2.380 pg/ml
STANDARD_DEVIATION 1.233 • n=7 Participants
|
2.39 pg/ml
STANDARD_DEVIATION 1.17 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
NATUR-OX Group (A)
n=18 Participants
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
|
Placebo Group (B)
n=18 Participants
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
|
|---|---|---|
|
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
|
16.03 pg/ml
Standard Deviation 3.521
|
|
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
|
110.7 pg/ml
Standard Deviation 8.805
|
|
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
|
95.34 pg/ml
Standard Deviation 3.982
|
|
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
|
15.86 pg/ml
Standard Deviation 3.847
|
|
Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0)
PTX3 (measurement unit: pg/ml)
|
410.7 pg/ml
Standard Deviation 46.34
|
415.6 pg/ml
Standard Deviation 52.73
|
|
Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0)
NO concentration (measurement unit: pg/ml)
|
2.401 pg/ml
Standard Deviation 1.140
|
2.380 pg/ml
Standard Deviation 1.233
|
SECONDARY outcome
Timeframe: 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 .
Outcome measures
| Measure |
NATUR-OX Group (A)
n=18 Participants
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
|
Placebo Group (B)
n=18 Participants
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
|
|---|---|---|
|
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
|
11.19 pg/ml
Standard Deviation 2.737
|
|
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
|
455.9 pg/ml
Standard Deviation 50.05
|
|
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
|
17.29 pg/ml
Standard Deviation 3.687
|
|
Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1)
IL-4 (measurement unit: pg/ml)
|
79.57 pg/ml
Standard Deviation 8.770
|
112.2 pg/ml
Standard Deviation 8.840
|
|
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
|
100.6 pg/ml
Standard Deviation 4.519
|
|
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
|
2.619 pg/ml
Standard Deviation 1.262
|
Adverse Events
NATUR-OX Group (A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group (B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place