Clinical Trial Supports Emollient “Plus” for Improving AD

Image Credit: © DermNet

Microbiome dysbiosis plays a key role in the pathogenesis of atopic dermatitis (AD), exacerbating disease severity.¹ Research shows that cutaneous dysbiosis can weaken the skin barrier, triggering heightened immune responses against commensal organisms and facilitating allergic sensitization.² A major bacterial culprit in AD, Staphylococcus aureus (S. aureus), induces interleukin-9 (IL-9), which drives Th2-mediated allergic inflammation, eosinophil and mast cell infiltration, and IgE secretion—ultimately worsening AD symptoms.³

Growing evidence suggests that topical pre-, post-, and probiotic therapies can help restore microbiome balance and improve AD outcomes. Emollients, a cornerstone of AD management, are recommended to strengthen the skin barrier, prevent flare-ups, and reduce reliance on topical steroids.⁴ European guidelines distinguish between standard emollients and “emollients plus,” which contain active ingredients such as bacterial lysates, flavonoids, and saponins to support microbiome health. One such ingredient, Vitreoscillafiliformis lysate (Aqua Posae Filiformis; APF), possesses antioxidant and antibacterial properties that enhance innate skin defense mechanisms.⁵

"Maintaining a healthy physical and microbial skin barrier integrity is important in the management of AD, especially preventing the over proliferation of S. aureus which contributes to flares and worsening of AD," researchers behind a recent study noted. Armed with this knowledge, researchers set out to compare the effectiveness of an “emollient plus” formulation against a 10% urea moisturizer.⁶

“Modern emollients “plus” have proven to improve skin barrier function and rebalance microbiome, thus improving clinical signs and symptoms of patients with AD, either used alone in the milder forms or in adjunct to topical or systemic drugs for the more severe types,” researchers concluded.

Clinical Study Design

The double-blind, randomized controlled clinical trial was conducted to evaluate the effectiveness of an emollient "plus" (Lipikar AP+M balm; La Roche-Posay Laboratoire Dermatologique) compared to a urea 10% moisturizer in patients with mild to moderate AD. The study enrolled 60 subjects, randomized into 2 groups using a simple random sampling method. Each group applied their assigned moisturizer twice daily for 12 weeks alongside standard topical steroid therapy for flare management. Clinical assessments included Severity Scoring of AD (SCORAD), Pruritus Visual Analog Scale (PVAS), Eczema Area and Severity Index (EASI), and Dermatology Life Quality Index (DLQI). Instrumental evaluations measured transepidermal water loss (TEWL), skin hydration, and skin pH.

Results

At baseline, researchers found no statistically significant differences between the groups. However, by week 4, they reported improvements in TEWL and skin pH were significant in the emollient "plus" group. By week 8, SCORAD and skin hydration showed notable improvements. At week 12, researchers stated PVAS, EASI, and DLQI scores demonstrated superior outcomes in the emollient "plus" group compared to the urea 10% group. "Statistically significant differences in favor of treatment in Group A for the investigated clinical and instrumental parameters were observed throughout the study," the researchers stated.

Tolerance and Safety

Researchers noted 3 subjects in the emollient "plus" group reported minimal erythema, which resolved within 3days without intervention. In contrast, they reported 8 subjects in the urea 10% group experienced erythematous macules, pruritus, and xerosis requiring antihistamine treatment for resolution.

Conclusion

The study’s findings suggest that emollients "plus" significantly improve AD symptoms by reinforcing the skin barrier and rebalancing microbiome composition. This supports the incorporation of active ingredients like APF into standard AD management strategies to optimize clinical outcomes and reduce reliance on corticosteroids. Researchers suggested that future studies should consider assessing additional parameters, such as skin elasticity and inflammation markers, for a more comprehensive evaluation of emollient efficacy.

References

1. Kong HH, Oh J, Deming C, et al. Temporal shifts in the skin microbiome associated with disease flares and treatment in children with atopic dermatitis. Genome Res. 2012;22(5):850-859. doi:10.1101/gr.131029.111
2. Hammond M, Gamal A, Mukherjee PK, et al. Cutaneous dysbiosis may amplify barrier dysfunction in patients with atopic dermatitis. Front Microbiol. 2022;13:944365. Published 2022 Nov 14. doi:10.3389/fmicb.2022.944365
3. García-Jiménez I, Sans-de San Nicolás L, Curto-Barredo L, et al. Heterogeneous IL-9 production by circulating skin-tropic and extracutaneous memory t cells in atopic dermatitis patients. Int J Mol Sci. 2024;25(16):8569. Published 2024 Aug 6. doi:10.3390/ijms25168569
4. Zelenkova H, Kerob D, Salah S, Demessant-Flavigny AL. Impact of daily use of emollient 'plus' on corticosteroid consumption in patients with atopic dermatitis: An open, randomized controlled study. J EurAcad Dermatol Venereol. 2023;37 Suppl 5:27-34. doi:10.1111/jdv.18947
5. Wollenberg A, Barbarot S, Bieber T, et al. Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I [published correction appears in J EurAcad Dermatol Venereol. 2019 Jul;33(7):1436. doi: 10.1111/jdv.15719.]. J EurAcad Dermatol Venereol. 2018;32(5):657-682. doi:10.1111/jdv.14891
6. Prakoeswa CRS, Huda BKN, Indrawati D, et al. Effectiveness and tolerability of an emollient "plus" compared to urea 10% in patients with mild-to-moderate atopic dermatitis. J Cosmet Dermatol. 2025 Feb;24(2):e70051. doi: 10.1111/jocd.70051. PMID: 39973079; PMCID: PMC11840286.