Sustained improvement of paediatric atopic dermatitis with a novel emollient plus: a 6-month double blind comparative study

Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease characterized by xerosis, pruritus, and alternating phases of flares and remission¹. Clinical guidelines recommend the use of dermocosmetic care in combination with topical corticosteroids as first‑line management to alleviate clinical symptoms and improve patients’ quality of life^2,3.

The present study aimed to evaluate the efficacy and tolerability of a balm emollient containing active ingredients (AD balm) compared with a glycerin‑based cream (GC) over a 6‑month period in infants and children with AD, with particular focus on the evolution of clinical signs and disease burden.

1. Lipozenčić J, Wolf R. Atopic dermatitis: an update and review of the literature. Dermatol Clin. 2007;25(4):605 -612.
2. Jackson EM, Robillard NF. The controlled use test in a cosmetic product safety substantiation program. J Toxicol Cut Ocular Toxicol . 1982;1(2):117 -32.
3. Serup J. A double -blind comparison of two creams containing urea as active ingredient. Assessment of efficacy and side -effects by non - invasive techniques and a clinical scoring scheme. Acta Derm Venereol Suppl (Stockh). 1992;177:34 -43

This controlled, comparative clinical study was conducted in Poland during winter and included 88 infants and children aged 3 months to 12 years with mild to moderate AD (SCORAD 16–40; mean score: 26). All participants presented with active flares at inclusion and had experienced at least 3 flares during the preceding 6 months (range: 3–12 flares; mean: 6).

At baseline, all subjects received an 8‑day course of topical corticosteroids (D‑8 to D0), combined with twice‑daily whole‑body and facial application of either the AD balm or GC, assigned at random. After cessation of corticosteroid therapy, participants continued applying the assigned skincare product alone for 6 months (D0 to M6).

Clinical evaluations using SCORAD and PO‑SCORAD (Patient‑Oriented SCORAD) were performed at D0, M2, M4, and M6, with changes assessed relative to D0 (skincare use only). SCORAD sub‑scores—including pruritus, insomnia, erythema, and xerosis—were specifically analyzed. Quality of life was also assessed throughout the study.

Subjective assessments included self‑reported AD flares and global product satisfaction. Tolerability and standardized skin photographs were also collected.

During the 6‑month period of exclusive use of the GC (D0–M6), mean SCORAD showed a reduction of 22% at Month 2 and 57% at Month 6 (compared to D0, p>0.001), while the AD balm demonstrated significant superior efficacy with ‑52% at M2 and ‑86% at M6 (compared to D0, p>0.001 versus D0 and GC). Improvements observed with PO‑SCORAD closely paralleled those obtained with SCORAD.

Across all SCORAD sub‑scores—including disease extent, lesion intensity, and subjective symptoms—the AD balm demonstrated greater improvements than GC. Notably, pruritus decreased significantly more with the AD balm (p>0.001 versus GC), with -48% at M2 and -87% at M6, compared with -17% and -56%, respectively, with GC. Similarly, insomnia decreased significantly more with the AD balm, with  -92% versus -65% with GC at M6 (p>0.01 between products)

Consistent with clinical improvement, children’s quality of life improved over time. The CDLQI score showed a significantly greater reduction with the AD balm at M6 (‑53%) compared with GC (‑35%) (p>0.01 between products). This difference was particularly evident for items related to social life (question 3 at M6) and daily activities (question 5 at M4), with scores threefold lower in the AD balm group (p>0.01 between products).

Subjective efficacy of the AD balm was rated positively by 79–100% of participants, and overall tolerability was excellent. Importantly, all subjects using the AD balm experienced a reduction in flare frequency during the 6‑month study period compared with the previous 6 months, and 88% reported no flares at all during treatment.

Over a 6‑month period, the novel emollient developed for AD patients demonstrated significantly superior efficacy compared with a glycerin‑based cream in improving disease severity and quality of life in infants and children with atopic dermatitis. The AD balm reduced SCORAD, improved key clinical and functional signs—including disease extent, erythema, xerosis, pruritus, and insomnia —substantially decreased flare frequency, and enhanced life comfort, supporting its role as an effective adjunctive skincare in pediatric AD.