Young children with moderate-to-severe atopic dermatitis can be treated safely and effectively with either topical tacrolimus or mild corticosteroids
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Updated: Jan 20, 2026

Effects of Exposure of Formaldehyde to a Rat Model of Atopic Dermatitis Induced by Neonatal Capsaicin Treatment
Published on: September 27, 2017
Miia Perälä1, Maria Ahola1, Tytti Mikkola1
1University of Helsinki and Helsinki University Hospital, Skin and Allergy Hospital, Helsinki, Finland.
Insights
Topical tacrolimus may offer better results than corticosteroids for young children with atopic dermatitis (AD) and early sensitization. This safe treatment option showed improved skin condition and reduced water loss in a comparative study.
Area of Science:
- Dermatology
- Pediatrics
- Immunology
Background:
- Atopic dermatitis (AD) is a common skin condition in children.
- Topical corticosteroids are a standard treatment for AD, but concerns exist regarding long-term safety in young children.
- Topical tacrolimus is an alternative treatment option for AD.
Purpose of the Study:
- To compare the efficacy and safety of topical tacrolimus versus topical corticosteroids in young children with moderate-to-severe atopic dermatitis.
- To evaluate treatment outcomes in children with and without signs of early sensitization.
Main Methods:
- An interim analysis of a 3-year randomized open-label study.
- 75 children aged 1-3 years with moderate-to-severe AD were enrolled.
- Patients were treated with either topical tacrolimus or topical corticosteroids.
Main Results:
- Both treatments showed improvement in eczema severity (EASI, IGA), transepidermal water loss (TEWL), and serum total immunoglobulin E (IgE).
- Children with early sensitization at baseline showed significantly greater improvement in TEWL and eczema area with tacrolimus at 12 months.
- No severe adverse effects were reported in either treatment group.
Conclusions:
- Topical tacrolimus may be more beneficial than corticosteroids for children with AD and early sensitization.
- Topical tacrolimus presents a safe and effective alternative for managing moderate-to-severe AD in young children.
Aim:
We collected evidence and safety data for topical tacrolimus in small children with atopic dermatitis (AD) and compared the usage with topical corticosteroid.
Methods:
This was an interim analysis of 75 patients (55% female) at 1 year of an ongoing 3-year randomised open-label comparative follow-up study of topical tacrolimus vs corticosteroid treatment. One- to three-year-old children with moderate-to-severe eczema referred to the Skin and Allergy Hospital in Helsinki, Finland, were enrolled.
Results:
Efficacy parameters, the Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), transepidermal water loss (TEWL), eczema area, serum total immunoglobulin E (IgE) and the blood eosinophil count, showed improvement in both groups during the study. However, patients with signs of early sensitisation at baseline (elevated serum total IgE, elevated eosinophil count, positive prick tests or specific IgEs to aero or food allergens) had statistically significantly lower TEWL at the eczema site and a smaller eczema area at 12 months in the tacrolimus group. No severe adverse effects were seen during the treatment.
Conclusion:
Children with AD and signs of early sensitisation appeared to benefit more from early tacrolimus than corticosteroid treatment. Small children may need stronger but nevertheless safe ointment options when treating moderate-to-severe AD.
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