A prospective, open-label in-use tolerance study of a ceramide-based moisturizing cream in infants and children

INTRODUCTION

The cutaneous barrier plays a pivotal role in mediating transepidermal permeability, sustaining cutaneous hydration, and providing frontline defense against xenobiotics, microbial pathogens, and diverse environmental stressors. Preservation of stratum corneum (SC) integrity, particularly its capacity to minimize transepidermal water loss (TEWL), is fundamental to epidermal homeostasis. Structurally, the SC is composed predominantly of terminally differentiated keratinocytes (corneocytes), interconnected corneodesmosomes and tight-junction-associated proteins, along with proteolytic breakdown products such as natural moisturizing factors and additional hygroscopic molecules.^[1,2] Infant and pediatric skin demonstrates incomplete structural and functional maturation, characterized by a thinner epidermis, enhanced percutaneous absorption, and inherently greater TEWL than adult skin. Consequently, this developmental immaturity increases susceptibility to chemical irritation, microbial colonization, and fluid imbalance.^[3] Atopic dermatitis (AD) is a chronic, intermittently exacerbating dermatosis marked by pronounced pruritus, erythematous inflammation, xerotic scaling, and substantial disruption of epidermal barrier architecture. It commonly presents in early childhood and is associated with a complex interplay of genetic predisposition, immune dysregulation, and environmental factors.^[4,5] Recent epidemiological analyses demonstrate substantial age-and region-dependent variability in AD prevalence. Notably, within pediatric populations residing in desert regions of India, approximately 30.1% of eczematous presentations have been attributed to AD.^[6]

Although our study was conducted in healthy individuals, maintaining skin barrier integrity remains essential, as even subclinical barrier weakness may increase susceptibility to xerosis and inflammatory skin disorders. Xerosis cutis is a multifactorial phenotype marked by compromised barrier integrity and diminished SC water content, which represents a hallmark manifestation and clinically significant exacerbating factor in AD, especially among pediatric patients.^[7] Structural immaturity of the epidermal barrier extends well into childhood, with the pediatric SC remaining roughly 30% thinner than that of adults. This reduced barrier thickness predisposes to augmented TEWL and heightens vulnerability to irritant exposure and transcutaneous allergen ingress.^[8] Global and region-specific epidemiological data consistently indicate that perturbations in epidermal barrier competence during infancy are strongly associated with the emergence of early-onset AD, with the majority of cases manifesting within the 1^st year of life.^[9] These observations underscore the imperative of sustaining optimal barrier function in otherwise healthy pediatric skin to mitigate the risk of subsequent dermatologic morbidity. The frequent identification of ceramide-deficient xerosis among children presenting with cutaneous complaints further reinforces the centrality of epidermal lipid repletion in maintaining barrier homeostasis.^[10]

Emollient formulations are routinely employed in healthy pediatric populations to ameliorate xerosis, preserve barrier integrity, and sustain cutaneous hydration and suppleness. Consistent application, particularly following bathing or under low-humidity environmental conditions, augments endogenous barrier mechanisms and diminishes susceptibility to irritant-induced discomfort.^[11,12] Prophylactic moisturization is particularly relevant in children at risk of AD, as early intervention may influence disease trajectories. Ceramide-containing emollients are strongly recommended as adjuvants because of their ability to replenish the lamellar bilayer and restore barrier integrity.^[10,13]

The investigational product was a ceramide-enriched emollient formulation that incorporates purified water, propylene glycol, glycerin, emulsifying wax, cyclomethicone, and a composite of botanical butters and aloe-derived constituents as its principal excipients. This multimodal composition is engineered to enhance SC hydration, reconstitute epidermal barrier architecture, and deliver a hypoallergenic, non-irritant moisturization profile. Recent human repeat insult patch test (HRIPT) evaluations have substantiated its favorable dermal tolerability and barrier-supportive effects.^[14,15] However, there is limited real-world evidence on its in-use tolerance in infants and children.

Therefore, this study was designed to evaluate the in-use tolerance of a ceramide-based test cream in infants and children over 15 days.

MATERIALS AND METHODS

RESULTS

A total of 35 participants were included in the study. There were no protocol deviations during the study.

Secondary outcomes

Parent assessment questionnaire

Parent-reported outcomes indicated a complete absence of cutaneous intolerance phenomena, including redness, edema, cutaneous dryness, roughness, and itching, throughout the 15-day treatment interval. The uniform lack of adverse subjective or observable skin changes further reinforces the product’s favorable dermatologic tolerability profile in infants/children under real-world application conditions [Table 3].

Table 3: Skin tolerance assessment using the Draize scale

Parameters	Day 0 score	Day 15 score
Redness	0	0
Edema	0	0
Cutaneous dryness	0	0
Roughness	0	0
Itching	0	0

Assessment questionnaire for parents

On Day 15, parental responses indicated strong satisfaction with the study product. Based on the questionnaire, 54.29% of parents agreed (score of 4), and 45.71% strongly agreed (score of 5) that the cream was mild and gentle on the child’s skin. Similarly, when asked whether the cream made the child’s skin soft and supple, 20% of parents agreed, and 80% strongly agreed. These findings suggest that the cream was well tolerated and perceived as effective in improving skin softness and maintaining gentleness [Figure 1].

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Figure 1:

Parents’ agreement with product attributes at Day 15.

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Overall, all parents unanimously agreed that the cream was mild and gentle on their child’s skin, enhanced skin softness and suppleness, and was suitable for daily use, without causing any adverse effects.

Adverse Event Summary

No adverse events were observed during the study.

DISCUSSION

In infants and children, moisturization constitutes a foundational component of routine cutaneous care. By augmenting the aqueous phase of the SC, emollient formulations enhance epidermal hydration and elevate SC water content. Concurrently, the occlusive properties of these agents mitigate transepidermal water loss, thereby preserving barrier integrity. Regular use also improves surface smoothness and alleviates xerotic manifestations. Consequently, irrespective of the presence or absence of active dermatitis, emollients should be applied consistently and comprehensively across the body in pediatric patients with eczema to support optimal barrier function and symptom control.^[16,17]

The findings from this investigation substantiate that the cream demonstrates an excellent safety and tolerability profile in infants and children. Across the 15-day observation period, clinician-assessed dermatologic endpoints revealed an absence of erythema or edema, while caregiver-reported outcomes indicated no treatment-emergent adverse events, collectively supporting its favorable acceptability in the pediatric population.

The strong cutaneous tolerability of the test formulation likely reflects its thoughtfully designed composition, which incorporates multiple barrier-supportive constituents, including ceramide subtypes (N-oleoylphytosphingosine [EOP], N-acylphytosphingosine [NP], N-acylsphingosine [AP]), oat-derived lipids (Avena sativa and Kernel Oil) and extracts (Bran Extract), and sodium hyaluronate, that collectively strengthen SC integrity and hydration dynamics. The addition of ceramides, which constitute essential components of SC intercellular lipids and are pivotal to cutaneous hydration and barrier integrity, is particularly meaningful in neonatal skin care. Given the immaturity of the neonatal epidermal barrier, ceramide-rich topical interventions have consistently demonstrated the most effectiveness in promoting barrier maturation and strengthening physiological defence mechanisms.^[18,19] Consistent with these mechanistic principles, our cohort exhibited no evidence of cutaneous dryness, further corroborating the barrier-preserving properties of the formulation in infants.

Oat-derived actives such as β-glucans and avenanthramides exert hydration-enhancing and anti-erythemic effects, possibly offering a mechanistic explanation for the absence of irritation observed in both adult and infant cohorts.^[20,21] This is consistent with evidence from a randomized, double-blind, controlled trial in which colloidal oatmeal lotion significantly improved scaling, dryness, and itch parameters, and maintained superior skin hydration through 21 days and a 1-week regression period (P < 0.05). Collectively, these data substantiate the role of oatmeal-based formulations in alleviating xerosis-related dryness and itching.^[22]

Skin tolerability represents a pivotal parameter influencing the sustained use and thus clinical efficacy of emollient-based interventions. Suboptimal tolerability, characterized by sensory irritation, stinging, or inadequate cosmetic elegance, can markedly diminish patient adherence, thereby undermining therapeutic success in AD management. In contrast, formulations exhibiting superior tolerability profiles facilitate regular application, a prerequisite for preserving epidermal barrier function and attenuating inflammatory exacerbations.^[23-25] The excellent tolerability profile observed in our study, with 100% parental agreement on gentleness and absence of irritation, suggests that this formulation meets these essential criteria for pediatric emollient products.

Our observations further reinforce the emerging evidence base by integrating objective dermatological endpoints with unanimously positive caregiver-reported outcomes. The complete concordance regarding the product’s gentleness, textural acceptability, routine applicability, and absence of irritant phenomena indicates that this formulation satisfies the fundamental performance and tolerability standards expected of pediatric emollient therapeutics. Its ceramide-fortified formulation ostensibly facilitates restoration and stabilization of epidermal barrier function while maintaining an exceptional tolerability profile.

Dry skin and suboptimal barrier function in children, even in the absence of clinically evident dermatologic conditions, are known to influence overall quality of life (QoL) by affecting comfort, sleep continuity, and skin responsiveness to environmental exposures. Although formal QoL instruments were not employed in this study, parental reports consistently highlighted the cream’s gentle action, favorable sensory attributes, and high level of acceptability, indirectly indicating enhanced daily comfort for both children and caregivers. At the conclusion of the 15-day application period, parents uniformly described the skin as well-conditioned, smooth, soft, and naturally supple. The parental feedback, emphasizing consistent impressions of softness, mildness, and overall skin nourishment, aligns closely with existing dermatologic evidence. Notably, findings parallel those of Sutton et al. (2022), who similarly documented strong parental satisfaction with the tolerability and ease of use of emollients formulated for pediatric skin care, further supporting the relevance and translational value of our observations.^[26]

For clinicians and caregivers, the findings presented herein provide robust support for the incorporation of cream into routine pediatric skincare protocols across a broad age spectrum, given its demonstrated dermatological safety and uniformly high user acceptability. Such evidence-driven endorsement is critical for optimizing adherence to emollient therapy and for establishing durable barrier-maintenance practices in children, particularly those with an intrinsically heightened vulnerability to irritant exposures. The convergence of clinical tolerability, barrier-supportive formulation design, and positive caregiver-reported outcomes renders this ceramide-based moisturizer a clinically rational and judicious choice for practitioners seeking reliable emollient options for pediatric patients.

The study possesses several methodological constraints that warrant consideration when interpreting the findings. The study employed a single-arm, monocentric design with a relatively small cohort of 35 infants and children, which inherently limits statistical power and restricts the generalizability of the observations to the broader pediatric population. The absence of a comparator or control group further precludes any definitive attribution of observed skin outcomes exclusively to the intervention. As the study was conceived exclusively as an in-use tolerance evaluation rather than an efficacy trial, no objective or instrument-based assessments of therapeutic benefit (hydration indices, barrier function metrics, or structured before–and–after improvement scores) were incorporated. These limitations collectively underscore the preliminary and descriptive nature of the tolerability conclusions. Despite these limitations, our findings contribute meaningful evidence supporting the safety and acceptability of ceramide-enriched emollients in pediatric skin care.

CONCLUSION

The cream was found to be well tolerated in infants and children, as demonstrated by clinical skin assessments and parental feedback. The product was associated with no adverse effects, and 100% of parents reported that the cream was mild and gentle on their child’s skin, improved skin softness and suppleness, and was suitable for daily use. These findings support the safety and acceptability of the cream for pediatric use.