A 1% colloidal oatmeal OTC cream is clinically effective for the management of mild to moderate atopic dermatitis in Black or African American children

Figures & data

Figure 1. Patient disposition. ^aDeviations included missed applications, incorrect completion of the study diaries or questionnaires, failure to return the creams, and incorrect calculation of study cream weight. ITT: intent-to-treat; OTC: over-the-counter; PP: per protocol.

Table 1. Demographics and baseline disease characteristics in the Black or African American cohort (ITT population).

	1% colloidal oatmeal cream	Prescription barrier cream	Total
	(n = 25)	(n = 24)	(n = 49)
Age (years)
Mean (SD)	6.1 (3.17)	9.4 (3.46)	7.7 (3.69)
Male sex, n (%)	14 (56.0)	10 (41.7)	24 (49.0)
Ethnicity, n (%)
Not Hispanic or Latino	25 (100.0)	24 (100.0)	49 (100.0)
Rating of atopic dermatitis severity, n (%)
Mild	6 (24.0)	7 (29.2)	13 (26.5)
Moderate	19 (76.0)	17 (70.8)	36 (73.5)
Concomitant conditions^a, n (%)
Acid reflux	0 (0)	2 (8.3)	2 (4.1)
Allergies^b	18 (72.0)	20 (83.3)	38 (77.6)
Asthma	8 (32.0)	9 (37.5)	17 (34.7)
EASI score, mean (SD)	3.6 (1.82)	3.2 (2.47)	3.4 (2.15)
IGADA score, mean (SD)	2.3 (0.48)	2.3 (0.61)	2.3 (0.54)
Patient/caregiver-rated signs/symptoms of eczema^c, mean (SD)
Itch	4.6 (2.57)	4.9 (2.83)	4.7 (2.68)
Skin appearance where eczema	4.9 (1.67)	4.3 (1.81)	4.6 (1.74)
Dryness/flakiness	3.7 (1.95)	3.0 (2.16)	3.3 (2.07)
Redness	6.2 (2.64)	6.9 (2.36)	6.5 (2.51)
Moisturization	3.6 (1.80)	3.3 (1.90)	3.4 (1.84)
Sleep quality	6.6 (2.50)	7.0 (2.92)	6.8 (2.69)

^aOccurring in >5% of patients.^bIncludes: soap, detergents, food (cherry, peanuts, egg, seafood), fragrances, pollen, dust mites, animals (cats, dogs), latex, amoxicillin, seasonal.^c1 = worst, 10 = best. EASI: Eczema Area and Severity Index; IGADA: Investigator’s Global Atopic Dermatitis Assessment; ITT: intent-to-treat; SD: standard deviation.

Table 2. Mean EASI and IGADA scores at baseline and over time and change from baseline scores in Black or African American patients (ITT population).

Time point	1% colloidal oatmeal cream (n = 25)	Prescription barrier cream (n = 24)
EASI Score, mean (SD)
Baseline	3.6 (1.82)	3.2 (2.47)
Week 1	1.3 (0.84)	1.5 (0.86)
Change from baseline	−2.2 (1.78)	−1.7 (2.31)
Week 2	1.2 (1.11)	1.3 (0.90)
Change from baseline	−2.4 (1.59)	−1.9 (2.55)
Week 3	1.2 (1.04)	1.0 (0.55)
Change from baseline	−2.4 (1.68)	−2.1 (2.33)
IGADA Score, mean (SD)
Baseline	2.3 (0.48)	2.3 (0.61)
Week 1	1.9 (0.57)	1.8 (0.64)
Change from baseline	−0.4 (0.65)	−0.4 (0.50)
Week 2	1.8 (0.65)	1.8 (0.56)
Change from baseline	−0.5 (0.71)	−0.4 (0.58)
Week 3	1.8 (0.72)	1.5 (0.59)
Change from baseline	−0.6 (0.65)	−0.7 (0.55)

EASI: Eczema Area and Severity Index Assessment is a scale of 0 (no disease anywhere on the body) to 72 (severest disease on all body areas); IGADA: Investigator’s Global Atopic Dermatitis Assessment is a scale from 0 = clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe, to 5 = Very severe; ITT, intent-to-treat; SD: standard deviation.

Figure 2. Black or African American patients’ and/or caregivers’ assessment of eczema signs and symptoms by time point based on 10-point scales: (A) itch; (B) skin appearance; (C) flakiness; (D) redness; (E) moisturization; (F) sleep quality, all in the ITT population. ^aWeek 1 data missing for one patient. ITT: intent-to-treat; OTC: over-the-counter; SD: standard deviation.

Table 3. Black or African American patients’ and/or caregivers’ assessment of eczema by time point: product rating (ITT population).

Time point/score	1% colloidal oatmeal cream (n = 25)	Prescription barrier cream (n = 24)
Satisfaction with current product (scale: 1 = not at all satisfied to 10 = very satisfied)
Day 0/baseline
n	25	23
Mean (SD)	6.9 (1.87)	6.3 (2.44)
Satisfied with study product (scale: 1 = not pleased at all to 10 = very pleased)
Day 21/week 3
n	25	24
Mean (SD)	8.4 (2.08)	8.7 (1.40)
Ease of application (scale: 1 = very difficult to 10 = very easy)
Day 21/week 3
n	25	24
Mean (SD)	9.6 (0.87)	9.8 (0.61)
Improved eczema (scale: 1 = no improvement at all to 10 = significantly improved)
Day 21/week 3
n	25	24
Mean (SD)	7.8 (1.71)	8.0 (1.73)
Skin feel (scale: 1 = very rough to 10 = very smooth)
Day 21/week 3
n	25	24
Mean (SD)	8.8 (1.11)	8.8 (0.94)
How likely to buy (scale: 1 = definitely would not buy to 10 = definitely would buy)
Day 21/week 3
n	25	24
Mean (SD)	8.2 (2.01)	8.3 (2.31)

ITT: intent-to-treat; SD: standard deviation.

Table 4. Black or African American patients’ and/or caregivers’ assessment of the product for eczema at week 3: overall product (ITT population).

Response, n (%)	1% colloidal oatmeal cream (n = 25)	Prescription barrier cream (n = 24)
Would you replace the product you/your child currently uses for eczema with the product you/your child used in this study?
No	7 (28.0)	8 (33.3)
Yes	17 (68.0)	16 (66.7)
No response	1 (4.0)	0 (0)
Is the product you used in this study appropriate for your whole family?
No	3 (12.0)	4 (16.7)
Yes	22 (88.0)	20 (83.3)
Is the product you used in this study appropriate for children?
Yes	25 (100.0)	24 (100.0)
Based on how the product feels, do you think this product is more appropriate for use on entire body?
No	1 (4.0)	3 (12.5)
Yes	24 (96.0)	18 (75.0)
No response	0 (0)	3 (12.5)
Based on how the product feels, do you think this product is more appropriate for use on eczema patches?
No	1 (4.0)	0 (0)
Yes	20 (80.0)	21 (87.5)
No response	4 (16.0)	3 (12.5)
Based on your experience with this test product, do you see yourself using this product daily or occasionally?
Daily	22 (88.0)	19 (79.2)
Occasionally	3 (12.0)	5 (20.8)

ITT: intent-to-treat.

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.