Introduction

Irritant contact dermatitis represents the leading cause of hand eczema (HE). Emerging evidence suggests that topical oatmeal formulations may effectively reduce inflammation and itching responses across a variety of dermatologic conditions.

Aim 

To evaluate the clinical benefit of colloidal oatmeal cream in the management of chronic irritant HE.

Patient Profile

• 63 patients age between 18 & 65 years old
• Clinical diagnosis of chronic irritant HE, moderate to severe severity of HE based on the HESCI score, lack of consuming any topical & systemic glucocorticoids during 4 weeks before the study & lack of consuming any topical and systemic antipruritic treatments during 2 weeks before the study.

Methods

• Randomized, double-blind, placebo-controlled trial study with a 6-weeks follow up
• Patients were allocated into either 
  1. Intervention group (fluocinolone 0.025% ointment + colloidal oatmeal 1% cream, N=32) 
  2. Control group (fluocinolone 0.025% ointment + base cream, N=31) 
  3. Fluocinolone 0.025% ointment was applied for the first 2 weeks of treatment period in control and intervention group.
  4. After 2 weeks patients in the intervention and control groups were asked to use colloidal oatmeal 1% cream or base cream for additional 4 weeks as monotherapy.

Primary Endpoints 

• The primary endpoint was the change in clinical severity of chronic hand eczema (HE) from baseline to weeks 2, 4, and 6 after treatment initiation.
• Severity was measured using the Hand Eczema Severity Index (HECSI), a physician-rated scoring system.
• HECSI Scoring Method
  1. Anatomical regions assessed: Each hand divided into 5 areas -fingertips, fingers (excluding tips), palms, back of hands, wrists.
  2. Clinical signs (Erythema, Induration/papulation, Vesicles, Fissuring, Scaling, Edema) graded (0–3 scale; 0, no skin changes; 1, mild; 2, moderate and 3, severe)
  3. Extent of involvement for each area (total of both hands) (0–4 scale ; (0, 0%; 1, 1–25%; 2, 26–50%; 3, 51–75% and 4, 76–100%). 
• The HECSI score is calculated by multiplying the extent of involvement for each anatomical area by the total sum of the intensity scores for all clinical features, resulting in a composite score that ranges from 0 to 360.
• Severity Categories (as per Oosterhaven & Schuttelaar) (Clear = 0, Almost clear = 1–16, Moderate = 17–37, Severe = 38–116, Very severe ≥117)

Secondary Outcomes

• Severity of Pruritus recorded at baseline, 2, 4, and 6 weeks after treatment initiation.
  • Measurement tool: Visual Analogue Scale (VAS), a 10‑cm horizontal line for self‑assessment.
  • Scoring: Patients rated itch intensity from 0 (no pruritus) to 10 (worst imaginable pruritus).
  • Categorization
    • Mild: VAS < 4.0
    • Moderate: VAS 4.0–7.0
    • Severe: VAS > 7.0
• Quality of Life Impact was compared between groups at baseline and week 6
  • Persian version of the Dermatology Life Quality Index(DLQI), validated for the Iranian population.
  • 10‑item self‑reported questionnaire covering six domains (Symptoms & feelings, Daily activities, Leisure, Work/school, Personal relationships, Treatment)
  • Scoring system (“Very much” = 3, “A lot” = 2, “A little” = 1, “Not at all” = 0
  • Compared between groups at baseline and week 6.

Results

Efficacy Results

Table 1: Comparison of Eczema Severity Based on the HECSI Tool Between 2 Groups at Different Time Points During the Study

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

HECSI, hand eczema severity index.

VAS Pruritus Scores (Table 2)

• No significant difference at baseline (P = 0.42). 
• VAS scores were significantly different in the 2 groups with more favourable outcomes in the intervention group (table 2)

Table 2: Comparison of Pruritus Severity Based on VAS Scores at Different Time Points During the Study Between the Two Groups 

VAS Score	Control (N=24)	Intervention (N=26)	P-value
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

Treatment Phase Outcomes

• Weeks 0–2 (fluocinolone + cream): Both groups showed comparable decreases in HECSI and VAS scores (Table 3)
• Weeks 2–6 (cream monotherapy)
  • Intervention group (colloidal oatmeal 1% cream) maintained improvements.
  • Control group (base cream) showed significant return of symptoms to baseline.
  • General linear model confirmed significant differences between groups over time (P < 0.001 for both HECSI and VAS).

Table 3 : Treatment Phase Outcomes: HESCI & VAS Scores

Time Point	HESCI (Mean ± SD)	Difference (Intervention – Control)	VAS (Mean ± SD)	Difference (Intervention – Control)
Baseline	Control:  67.00 ± 4.40  Intervention: 67.69 ± 4.23	+0.69	Control:  5.63 ± 0.27  Intervention: 5.92 ± 0.26	+0.29
Week 2	Control:  35.79 ± 2.38  Intervention: 28.77 ± 3.50	–7.02	Control:  2.46 ± 0.32  Intervention: 1.62 ± 0.31	–0.84
Week 4	Control:  44.83 ± 4.58  Intervention: 25.80 ± 4.39	–19.03	Control:  3.75 ± 0.34  Intervention: 1.65 ± 0.32	–2.10
Week 6	Control:  54.13 ± 6.42  Intervention: 23.73 ± 6.17	–30.40	Control:  4.66 ± 0.43  Intervention: 1.50 ± 0.42	–3.16

Severity Distribution Analysis

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)

 

• At baseline, both groups had moderate to severe HE
• By weeks 2, 4 & 6 (see table 4)
  • Colloidal oatmeal group: Shifted toward better severity categories ie clearer+ Almost clear disease [difference n(%); wk 2: 4(+14.4); wk 4; 11(+41.3), Wk 6 ; 15 (+56.7)]
  • Control group: Less improvement, with more patients remaining in moderate/severe categories [difference n(%): wk 2: 2(−14.5), wk 4: -9(−41.3); wk 6; -13 (−56.7)]
• Pruritus severity (VAS categories)
  • Oatmeal cream group consistently showed superior reduction in itch severity compared to base cream.

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)

Quality of Life (DLQI)

• The reduction in DLQI was significantly greater in the intervention group compared to the control group (P < 0.001) at study end.

• Baseline DLQI Scores
• Intervention group (colloidal oatmeal cream): 12.88 ± 2.67
• Control group (base cream): 12.92 ± 2.30
• Both groups started with comparable impairment in dermatology‑related quality of life.
• Week 6 DLQI Scores
• Intervention group: 5.58 ± 5.35
• Control group: 10.92 ± 3.78

Safety and Tolerability Summary

• Adverse Events
  • Control group: 3 patients (Burning =1 case ; Itching=2 cases)
  • Intervention group: 4 patients (Burning =2 cases,  erythema& itching= 1 each)
• Study Discontinuation due to Intolerable Events
  • Control group: 1 patient.
  • Intervention group: 1 patient.
  • No difference between groups.
• None of the adverse events were serious or caused complications; overall, colloidal oatmeal 1% cream was well tolerated & demonstrated comparable safety to base cream.

Conclusions

• Colloidal oatmeal, with its barrier-protective, moisturizing, anti-inflammatory, and soothing qualities, helps reduce the severity of eczema symptoms in chronic irritant hand eczema.
• Colloidal oatmeal is a useful adjunct therapy for managing irritant hand eczema and other inflammatory skin conditions.

Reference

Clin. Cosmet. Investig. Dermatol. 2020:13 241–251.