Pilot Studies on Two Complementary Bath Products for Atopic Dermatitis Children: Pine-Tar and Tea
Abstract
:1. Introduction
2. Materials and Methods
2.1. Subject Recruitment
2.2. Study Design
2.3. Studied Product
2.4. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Conflicts of Interest
References
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Patient Information | Median (IQR) for Tea Bath Study | Median (IQR) for Pine-Tar Bath Study |
---|---|---|
Sex (%) | 8 (40.0) Male 12 (60.0) Female | 5 (55.6) Male 4 (44.4) Female |
Age (Years) | 10.8 (7.5–15.7) | 10.3 (7.1–13.9) |
Objective SCORAD (SCORAD without the subjective components) | 33.3 (24.8–45.5) | 40.8 (22.2–56.6) |
POEM | 18.5 (13.0–23.0) | 17.7 (12.0–23.0) |
NESS | 15 Severe; 2 Moderate | 7 Severe; 2 Moderate |
CDLQI | 9.0 (6.0–16.0) | 11.0 (10.0–16.5) |
PADQLQ | - | 50.0 (24.5–54.0) |
SH (a.u.) | 18.7 (14.7–31.5) | 10.2 (7.6–14.7) |
TEWL (g/m2/h) | 7.1 (5.3–11.9) | 13.5 (7.4–18.0) |
Erythema(a.u.) | - | 414.0 (393.0–418.5) |
Eosinophil % | 7.0 (4.0–10.0) | 8.0 (6.3–9.8) |
IgE (IU/mL) | 3581.5 (1650.5–5894.5) | 3169.0 (1041.5–8181.5) |
Log [IgE] | 3.5 (3.2–3.7) | 3.5 (3.0–3.9) |
S. aureus colonization (Number, %) | 12 (60.0) | 3 (42.9) |
Days using topical steroid/week | 3.0 (1.0–7.0) | 2.0 (0.0–2.0) |
Days using oral anti-histamines/week | 2.0 (0.0–6.5) | - |
Tea Bath Study | Pine-Tar Bath Study | |||||
---|---|---|---|---|---|---|
Pre | Post | p-Value | Pre | Post | p-Value | |
Objective SCORAD | 33.3 (24.8–45.5) | 29.9 (16.4–37.4) | 0.324 | 40.8 (22.2–56.6) | 32.1 (17.4–50.7) | 0.050 |
POEM | 18.5 (13.0–23.0) | 16.5 (12.0–23.0) | 0.393 | 17.7 (12.0–23.0) | 15.0 (11.0–17.5) | 0.021 |
CDLQI | 9.0 (6.0–16.0) | 10.5 (8.0–19.0) | 0.305 | 11.0 (10.0–16.5) | 8.0 (4.0–11.5) | 0.011 |
PADQLQ | - | - | - | 50.0 (24.5–54.0) | 29.0 (19.0–41.0) | 0.036 |
SH (a.u.) | 18.7 (14.7–31.5) | 18.5 (14.1–34.6) | 0.575 | 10.2 (7.6–14.7) | 18.0 (11.4–20.5) | 0.192 |
TEWL (g/m2/h) | 7.1 (5.3–11.9) | 8.8 (5.2–13.3) | 0.970 | 13.5 (7.4–18.0) | 10.7 (9.4–21.1) | 0.441 |
Erythema (a.u.) | - | - | - | 414.0 (393.0–418.5) | 401.0 (396.5–415.5) | 0.722 |
Eosinophil % | 7.0 (4.0–10.0) | 7.0 (4.0–9.0) | 0.858 | 8.0 (6.3–9.8) | 7.0 (7.0–10.5) | 0.172 |
IgE (IU/mL) | 3581.5 (1650.5–5894.5) | 3277.0 (1611.0–6175.0) | 0.814 | 3169.0 (1041.5–8181.5) | 2355.0 (948.5–9032.8) | 0.141 |
Log [IgE] | 3.5 (3.2–3.7) | 3.5 (3.2–3.7) | 3.5 (3.0–3.9) | 3.3 (3.0–4.0) | ||
S. aureus status (no growth) | 8 (40.0) | 9 (45.0) | 0.257 | 3 (42.9) | 6 (66.7) | 0.386 |
GAT | ||||||
Very good or Good | 14 (70.0) | 7 (77.8) | ||||
Fair or Poor | 6 (30.0) | 2 (22.2) |
One-Sided α= | 0.005 | 0.025 | 0.05 | ||||||
---|---|---|---|---|---|---|---|---|---|
Two-Sided α= | 0.01 | 0.05 | 0.10 | ||||||
E/S* β= | 0.05 | 0.10 | 0.20 | 0.05 | 0.10 | 0.20 | 0.05 | 0.10 | 0.20 |
0.10 | 3565 | 2978 | 2338 | 2600 | 2103 | 1571 | 2166 | 1714 | 1238 |
0.15 | 1586 | 1325 | 1040 | 1157 | 935 | 699 | 963 | 762 | 551 |
0.20 | 893 | 746 | 586 | 651 | 527 | 394 | 542 | 429 | 310 |
0.25 | 572 | 478 | 376 | 417 | 338 | 253 | 347 | 275 | 199 |
0.30 | 398 | 333 | 262 | 290 | 235 | 176 | 242 | 191 | 139 |
0.40 | 225 | 188 | 148 | 164 | 133 | 100 | 136 | 108 | 78 |
0.50 | 145 | 121 | 96 | 105 | 86 | 64 | 88 | 70 | 51 |
0.60 | 101 | 85 | 67 | 74 | 60 | 45 | 61 | 49 | 36 |
0.70 | 75 | 63 | 50 | 55 | 44 | 34 | 45 | 36 | 26 |
0.80 | 58 | 49 | 39 | 42 | 34 | 26 | 35 | 28 | 21 |
0.90 | 46 | 39 | 32 | 34 | 27 | 21 | 28 | 22 | 16 |
1.00 | 38 | 32 | 26 | 27 | 23 | 17 | 23 | 18 | 14 |
Steps | Calculation Example using Pine-Tar Study |
---|---|
Step 1—Determine effect size from pilot study: | Effect size = 40.8 − 32.1= 8.4 (obj. SCORAD score) |
Step 2—Determine SD of outcome variable | SD = around 12 ** |
Step 3—Determine Standardized effect size | Standardized effect size = effect size/SD = 8.4/12 = 0.725 |
Step 4—Decide α (probability of Type I error) and β (probability of Type II error) | α (two sided) = 0.05; β = 1 − 0.80 = 0.20; |
Step 5—Find out expected sample size per group from Table 3 | Using Table 3, around 34 participants per group would be required for a future randomized controlled trial. |
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Hon, K.L.; Ng, W.G.G.; Kung, J.S.C.; Leung, P.C.; Leung, T.F. Pilot Studies on Two Complementary Bath Products for Atopic Dermatitis Children: Pine-Tar and Tea. Medicines 2019, 6, 8. https://doi.org/10.3390/medicines6010008
Hon KL, Ng WGG, Kung JSC, Leung PC, Leung TF. Pilot Studies on Two Complementary Bath Products for Atopic Dermatitis Children: Pine-Tar and Tea. Medicines. 2019; 6(1):8. https://doi.org/10.3390/medicines6010008
Chicago/Turabian StyleHon, Kam Lun, Wing Gi Gigi Ng, Jeng Sum C. Kung, Ping Chung Leung, and Ting Fan Leung. 2019. "Pilot Studies on Two Complementary Bath Products for Atopic Dermatitis Children: Pine-Tar and Tea" Medicines 6, no. 1: 8. https://doi.org/10.3390/medicines6010008
APA StyleHon, K. L., Ng, W. G. G., Kung, J. S. C., Leung, P. C., & Leung, T. F. (2019). Pilot Studies on Two Complementary Bath Products for Atopic Dermatitis Children: Pine-Tar and Tea. Medicines, 6(1), 8. https://doi.org/10.3390/medicines6010008