From the Guidelines
Urea 5% is considered safe for use in children, but its application should be limited and under guidance, especially in those under 2 years of age. When considering the use of urea 5% in children, it's essential to weigh the benefits against potential risks, focusing on morbidity, mortality, and quality of life. The management of skin conditions in children, such as ichthyoses, involves the use of emollients to improve skin hydration [ 1 ]. According to the European guidelines of care for congenital ichthyoses, emollients are recommended for all ichthyoses, applied as often as necessary, at least twice a day, and ideally after bathing [ 1 ]. However, for children under 2 years, the application of urea, even at lower concentrations like 5%, should be approached with caution and ideally restricted to once daily on limited areas.
Key considerations for the use of urea 5% in children include:
- Application frequency and area: Limited to once daily and on restricted areas for children under 2 years.
- Concentration: While urea concentrations of 10% or higher are not recommended before the age of 1 year [ 1 ], a 5% concentration may be considered safer, but still, caution is advised.
- Monitoring: Parents or caregivers should monitor for signs of irritation, redness, or discomfort after application.
- Medical supervision: For specific conditions like severe eczema or ichthyosis, or for very young children, consultation with a pediatrician or dermatologist is recommended to determine the appropriate concentration and application frequency.
Given the current evidence, the use of urea 5% in children should be guided by the principle of minimizing potential harm while maximizing therapeutic benefit, especially considering the lack of comparative studies on different emollients in this age group [ 1 ]. Therefore, a cautious approach, with careful consideration of the child's age, skin condition, and potential for adverse effects, is advisable when deciding to use urea 5% in pediatric patients.
From the Research
Urea 5% Safety in Children
- The safety of urea 5% in children has been evaluated in several studies 2, 3, 4, 5, 6.
- A study comparing the potential for irritation of a ceramide-based moisturizer with a urea 5% moisturizer for pediatric atopic dermatitis found that the ceramide-based cream had a significantly lower mean VAS score for irritation compared with urea 5% cream 2.
- Another study on the efficacy of urea therapy in children with ichthyosis found that a urea 10% lotion had a strong positive effect on generalized ichthyotic keratinization disorders, with response rates of 65% after 4 weeks and 78% after 8 weeks 3.
- A review of the use of urea in dermatology discussed its mechanism of action, safety profile, and frequent indications, including atopic dermatitis, ichthyosis, and psoriasis, and found that urea-based products are well tolerated, with mild side effects more frequent at high concentrations 4.
- A comprehensive review of the clinical literature on urea found that it is a safe and effective dermatologic therapy with wide-ranging clinical utility and minimal, non-systemic side effects, including mild irritation as the most common adverse event 5.
- The safety assessment of urea by the Cosmetic Ingredient Review (CIR) Expert Panel concluded that urea is safe as used in cosmetic products, although it can cause uncoiling of DNA and increase the percutaneous absorption of other chemicals 6.
Key Findings
- Urea 5% may cause irritation in some children, but it is generally considered safe for use in pediatric patients 2, 6.
- Urea therapy has been shown to be effective in treating various skin conditions in children, including ichthyosis and atopic dermatitis 3, 4, 5.
- The safety profile of urea is well established, with mild side effects and no significant systemic toxicity 4, 5, 6.