Table 1.
Demographic and clinical characteristics of the participants at baseline.
| PLACEBO | DRUG | P-VALUE† | |
|---|---|---|---|
| n= 20 | n= 40 | ||
| Age (mean, SD) | 41·3 (16·3) | 40·5 (14·9) | 0·855 |
| BMI (mean, SD) ¶ | 27·4 (6·4) | 27·7 (5·9) | 0·866 |
| Gender (n,%) | 0·360 | ||
| Female | 11 (55·0%) | 17 (42·5%) | |
| Male | 9 (45·0%) | 23 (57·5%) | |
| Race (n, %) | 0·51 | ||
| Asian | 5 (25%) | 10 (25%) | |
| African American | 10 (50%) | 14 (35%) | |
| Caucasian | 5 (25%) | 16 (40%) | |
| IgE Group (n,%) * | 0·620 | ||
| Intrinsic | 4 (20%) | 6 (15%) | |
| Extrinsic | 16 (80%) | 34 (85%) | |
| Total serum IgE, kU/L (mean, SD) | 6,592 (9,720) | 3,646 (4,561) | 0·638 |
| SCORAD (mean, SD) § | 55·5 (13·4) | 53·4 (13·1) | 0·568 |
| SCORAD (range) | 34·5-89 | 36-84·5 | |
| SCORAD <50 (n,%) | 8 (40%) | 20 (50%) | 0.46 |
| SCORAD ≥50 (n,%) | 12 (60%) | 20 (50%) | |
| IGA (n, %) # | 0·66 | ||
| Moderate (3) | 15 | 32 | |
| Severe (4) | 5 | 7 | |
| Very severe (5) | 0 | 1 | |
| BSA (mean, SD) $ | 38·15 (24·26) | 42·68 (27·7) | 0·52 |
| HISTORY OF ASTHMA (n,%) ‡ | 0·89 | ||
| As child only | 4 (20%) | 6 (15%) | |
| No | 10 (50%) | 22 (55%) | |
| Yes | 6 (30%) | 12 (30%) |
Data are given as mean±SD (standard deviation) or as percentage (%).
Body mass index (BMI) is the weight in kilograms divided by the square of the height in meters.
Intrinsic and extrinsic patients were assigned according to baseline total serum IgE levels of <200kU/L or >200kU/L, respectively.
Scores on the SCORAD (SCORing Atopic Dermatitis) range from 0 to 103, with higher scores indicating greater severity; non-severe and severe disease was scored as SCORAD<50 and SCORAD≥50, respectively.
The Investigator’s Global Assessment (IGA) of the severity of atopic dermatitis was scored on a scale of 0 (clear) to 5 (very severe)
Body surface area (BSA) was graded from 0 (no skin involvement) to 100% (total skin involvement)
History of asthma as per patient history.
For numerical variables (Age, BMI, SCORAD, BSA, total serum IgE), differences between the means by treatment were tested using a two-tailed Sudent’s t-test for independent samples. The proportions by treatment for categorical variables (gender, race, IgE group, SCORAD50, IGA, History of Asthma) were compared using a Fisher’s exact test.