Reference
Lisante TA, Kizoulis M, Nuñez C, Hartman CL. 1% colloidal oatmeal OTC cream is clinically effective for the management of mild to moderate atopic dermatitis in Black or African American children. J Dermatolog Treat. 2023;34:1:2241587.
Study Objective
To determine if colloidal oatmeal cream compared to prescription barrier cream is effective for atopic dermatitis (AD) in Black or African American* children as a subgroup in a post hoc analysis of a prior trial
Key Takeaway
Over-the-counter (OTC) 1% oatmeal cream was at least as effective and safe as prescription barrier cream in this population. This result is consistent with the original, larger cohort (N=90).
Design
Post-hoc analysis of a randomized, double-blind, 2-arm trial
Participants
This post-hoc analysis used data from a prior 2011 study (49 Black/African American children and 41 non-Black/African American children) that found no difference between the 2 arms.1 There were 25 participants (56% male; average age 6.1 years) in the oatmeal arm and 24 participants (42% male; average age 9.4 years) in the ceramide-containing barrier-cream arm.
The inclusion and exclusion criteria of the original study consisted of the following:
- Aged 6 months to 18 years
- Diagnosis of mild-to-moderate atopic dermatitis (graded between 3.0 and 7.5 inclusive using Hanifin and Rajka criteria)
- Parents who identified their child as Black/African American
- Concomitant use of class IV–VII corticosteroids was permitted.
Key exclusion criteria were AD requiring systemic, superpotent (class I) or potent (classes II or III) topical corticosteroids or >2.0 mg/d inhaled or intranasal corticosteroids, and any topical or systemic therapy for viral, mycotic, or bacterial diseases.
Intervention
All participants were asked to use 1% oatmeal cream or prescription barrier cream twice daily or as needed for 3 weeks.
Study Parameters Assessed
The following scores were taken at baseline and the primary endpoint, week 3. They were also assessed at secondary endpoints (end of week 1 and week 2).
- Eczema Area and Severity Index (EASI): A dermatologist assessed the severity and extent of the dermatitis on 4 body regions (head/neck, trunk, upper limbs, and lower limbs) using the EASI.
- Investigators’ Global Atopic Dermatitis Assessment (IGADA): A dermatologist also used the IGADA, which uses a simple 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe.
The participants and/or their parents also filled out quality-of-life (QoL) questionnaires that assessed symptoms of eczema, product rating, and overall product performance.
Primary Outcome
Changes in EASI scores from baseline to study conclusion (3 weeks). Secondary outcome: changes in IGADA scores from baseline to 3 weeks.
Key Findings
The results from this subgroup analysis were in keeping with the analysis of the original trial population. Specifically, the 1% oatmeal topical cream was as effective as the ceramide-containing barrier cream.
EASI scores
At week 3, mean (standard deviation, SD) changes from baseline in EASI scores were −2.4 (1.7) with 1% oatmeal cream and −2.1 (2.3) with barrier cream; improvements were observed from week 1.
IGADA scores
At week 3, mean (SD) changes from baseline in IGADA scores were −0 .6 (0.7) and −0.7 (0.6), respectively. Improvements in subjective ratings of signs/symptoms of eczema were observed. Both study treatments were well-tolerated.
Transparency
Trial ID: NCT01326910. According to the study, “The work was funded by Johnson & Johnson Consumer Inc, A subsidiary of Kenvue.” In addition, all the authors are employees or consultants for Johnson & Johnson, directly or indirectly (Janssen Global Services, LLC).
Practice Implications & Limitations
Even after adjusting for socioeconomic factors, Black children are 1.7 times more likely to develop atopic disease compared to White children2 and are more likely to have severe disease. Diagnosis may be delayed due to the complexity of discerning signs of atopic disease in darker skin tones, and Black patients have an increased incidence of corticosteroid-induced hypopigmentation, making nonsteroidal treatments desirable.3 Despite this, the current body of literature before this article had not specifically addressed the efficacy of topical colloidal oatmeal in people of color.
The authors note that colloidal oatmeal “contains a variety of lipids that help restore the skin barrier by promoting epidermal differentiation, lipid synthesis, and ceramide processing, and reducing transepidermal water loss,” and that it promotes normalization of the skin pH. These actions are similar to the barrier-function restoration achieved by prescription barrier creams.
Black patients have increased incidence of corticosteroid-induced hypopigmentation, making nonsteroidal treatments desirable.
In Black patients in the study, colloidal oatmeal was not inferior to prescription barrier cream for treatment of mild-to-moderate atopic dermatitis, as evidenced by improvements in EASI and IGADA scores, along with caregivers’ subjective assessments of severity. The sample size was inadequately powered for strong results (N=49), making the findings more of a pilot study.
A noticeable limitation of this study is that it compares colloidal oatmeal cream to prescription barrier cream, not to steroid cream. An improvement in the study would have been to assess whether colloidal oatmeal cream decreased steroid cream use, since this clinical element is of particular interest in this study group due to the issue of hypopigmentation with chronic steroid use. One might infer that it does, given the improvements in objective and subjective symptom scoring, but that is not explicitly studied or stated in this article.
Additionally, the study would be more clinically impactful if there were a third arm comparing low-potency steroid cream to colloidal oatmeal. Presumably, many patients and clinicians will use barrier creams and colloidal oatmeal in tandem or interchangeably due to their safety and efficacy, but it would be clinically useful to compare colloidal oatmeal to the steroid cream. It would also be helpful if the study included children younger than 2 years, as many parents are reluctant to use prescription medications on young children.
Despite the small sample size and limited scope of the study, it may be helpful for clinicians to know that colloidal oatmeal is noninferior to barrier creams, particularly for parents who ask about more “natural” or nonprescription treatment options. In an effort to improve health equity, it is also important to see research directed specifically at improved outcomes for Black patients.
*The study used the clinical self-identifier “Black or African American.”
