The Efficacy of Colloidal Oatmeal Cream 1% as Add-on Therapy in the Management of Chronic Irritant Hand Eczema: A Double-Blind Study

Figures & data

Figure 1 The flowchart of the study.

Table 1 Baseline Demographic and Clinical Characteristics of the Per Protocol Population

Variable	Groups		P value
	Control (N=24)	Intervention (N=26)
Gender (N; male/female)	6/18	8/18	0.76
Age (years; mean ± SD)	33.17 ± 10.55	30.42 ± 9.13	0.33
BMI (Kg/m^2; mean ± SD)	25.05 ± 3.91	24.04 ± 4.30	0.40
HE duration (months; mean ± SD)	31.75 ± 26.50	37.73 ± 47.96	0.59
HECSI score at baseline (mean ± SD)	67.00 ± 4.40	67.69 ± 4.23	0.91
VAS score at baseline (mean ± SD)	5.63 ± 0.27	5.92 ± 0.26	0.42

Abbreviations: eBMI, Body Mass Index; HE, hand czema; HECSI, hand eczema severity index; VAS, visual analogue scale.

Figure 2 (A) Mean hand eczema severity index (HESI) score at different time points during study (P-value<0.001). (B) Mean pruritus score based on the VAS scale at different time points during study (P-value<0.001).

Table 2 Comparison of Eczema Severity Based on the HECSI Tool Between 2 Groups at Different Time Points During the Study (as Mean ± SD)

HECSI Score	Groups		P-value
	Control (N=24)	Intervention (N=26)
Baseline	67.00 ± 4.40	67.69 ± 4.23	0.91
Week 2	35.79±2.38	28.77 ± 3.50	0.03
Week 4	44.83 ± 4.58	25.80 ± 4.39	0.004
Week 6	54.13 ± 6.42	23.73 ± 6.17	0.001

Abbreviation: HECSI, hand eczema severity index.

Table 3 Comparison of Pruritus Severity Based on the VAS Scale Between 2 Groups at Different Time Points During the Study (as Mean ± SD)

VAS Score	Groups		P-value
	Control (N=24)	Intervention (N=26)
Baseline	5.63 ± 0.27	5.92 ± 0.26	0.42
Week 2	2.46±0.32	1.62 ± 0.31	0.06
Week 4	3.75 ± 0.34	1.65 ± 0.32	<0.001
Week 6	4.66 ± 0.43	1.50 ± 0.42	<0.001

Abbreviation: VAS, visual analogue scale.

Table 4 Comparison of Prevalence Distribution of HECSI Severity Between 2 Groups at Different Time Points During the Study

HECSI Severity		Clear n (%)	Almost Clear n (%)	Moderate n (%)	Severe n (%)	P-value
Baseline	Intervention group	0(0)	0(0)	5(19.2)	21(80.8)	0.42
	Control group	0(0)	0(0)	2(8.3)	22(91.7)
Week 2	Intervention group	0(0)	7(26.9)	14(53.8)	5(19.2)	0.03
	Control group	0(0)	3(12.5)	13(54.2)	8(33.3)
Week 4	Intervention group	0(0)	14(53.8)	6(23.1)	6(23.1)	0.002
	Control group	0(0)	3(12.5)	5(20.8)	16(66.7)
Week 6	Intervention group	7(26.9)	11(42.3)	2(7.7)	6(23.1)	<0.001
	Control group	0(0)	3(12.5)	6(25.0)	15(62.5)

Notes: Hand eczema severity index (HECSI) severity was categorized as follows: clear, 0; almost clear, 1–16; moderate, 17–37; severe, 38–116; very severe, ≥117.

Table 5 Comparison of Prevalence Distribution of VAS Severity Between 2 Groups at Different Time Points During the Study

VAS Severity		None n (%)	Mild n (%)	Moderate n (%)	Severe n (%)	P-value
Baseline	Intervention group	0(0)	1(3.8)	17(65.4)	8(30.8)	0.76
	Control group	0(0)	1(4.2)	18(75.0)	5(20.8)
Week 2	Intervention group	13(50.0)	10(38.5)	3(11.5)	0(0)	0.03
	Control group	4(16.7)	13(54.2)	7(29.2)	0(0)
Week 4	Intervention group	12(46.2)	8(30.8)	6(23.1)	0(0)	0.006
	Control group	2(8.3)	8(33.3)	11(45.8)	3(12.5)
Week 6	Intervention group	7(36.9)	14(53.8)	5(19.2)	0(0)	<0.001
	Control group	1(4.2)	8(33.3)	8(33.3)	7(29.2)

Notes: Visual analogue scale (VAS) severity was categorized as follows: mild pruritus (VAS<4.0), moderate pruritus (VAS 4.0–7.0), and severe pruritus (VAS>7.0).

Table 6 Comparison of the Impact of Skin Disorder on Patients’ Quality of Life Based on the DLQI Score in the Two Groups at Baseline and at the End of the Study Period (as Mean ± SD)

VAS Score	Groups		P-value
	Control (N=24)	Intervention (N=26)
Baseline	12.92±2.30	12.88±2.67	0.96
End of the study (week 6)	10.92±3.78	5.58±5.35	<0.001

Abbreviation: DLQI, Dermatology Life Quality Index.