Managing an Itchy Rash in an Infant
This interactive case study was organised and funded by Viatris. UK Prescribing Information for pimecrolimus can be found here. For any HCPs outside of the UK, please refer to your local guidelines, as information may vary.
Please report adverse drug reactions to Viatris at: https://www.viatrisconnect.com/en/viatris-ae
These interactive case studies were developed with support from Giuseppe Micali and Francesco Lacarrubba, Dermatology Clinic, University of Catania, Italy.
1/17
Patient Background
A 4-month-old female infant presented with itching and red skin patches involving the neck and elbow.
The caregiver reported that skin symptoms had worsened over the past week.
Symptoms were associated with increased crying and disturbed sleep.
2/17
Examination revealed localised erythematous inflammatory plaques involving the neck folds and antecubital region. Fine desquamation was present. There were no signs of secondary infection such as oozing, crusting, or pustules.
Right side of the neck
Left side of the neck
Right elbow
3/17
Question 1: What is your diagnosis?
D
Scabies
C
Psoriasis
B
Atopic dermatitis
A
Seborrheic dermatitis
4/17
Answer: Atopic dermatitis
Based on the clinical presentation, a diagnosis of moderate atopic dermatitis (AD) was made.
The infant presented with pruritic erythematous inflammatory plaques involving the neck folds and antecubital region, a typical distribution for infantile AD.
The presence of significant pruritus with sleep disturbance and irritability is consistent with moderate disease severity.
5/17
Why not the other options?1
Characterised by salmon-red erythematous patches with greasy scale, commonly involving scalp. Typically associated with little or no pruritus.
Click to view
Presents as well-demarcated erythematous patches, usually with minimal scaling. It often affects the diaper area.
May present as a diffuse eruption. Suggested by involvement of skin folds and the presence of vesicopustules on the palms and soles.
6/17
Footnote
1. Silverberg et al. Atopic dermatitis (eczema): pathogenesis, clinical manifestations, and diagnosis. Available at: https://www.uptodate.com/contents/ atopic-dermatitis-eczema-pathogenesis-clinical-manifestations-and-diagnosis. Last accessed: 9 January 2026.
Footnote:
Question 2: How would you treat this patient?
Crisaborole
Tacrolimus ointment
Pimecrolimus cream
Topical corticosteroids
7/17
Pimecrolimusis the only TCI approved for infants from 3 months of age
Only few TCS have been approved for infants.1 TCS may be associated with limitations due to potential local side effects, including skin infections and skin atrophy, which limit their use for treatment of sensitive skin areas.1
TCS (Topical corticosteroids)
TCI (Topical calcineurin inhibitors)
Pimecrolimus
Treatment Options in Infants
Do not cause skin atrophy. Valuable in delicate skin areas, such as the face and neck.2
The rationale to use TCI in infants:2
Evidence on TCI use in infants has been generated predominantly with pimecrolimus (>4,000 infants), confirming its effectiveness and tolerability.1
Pimecrolimus is the only TCI approved from 3 months of age and above by the European Medicines Agency (EMA).3,4
8/17
1. Luger T et al. Unmet medical needs in the treatment of atopic dermatitis in infants: an expert consensus on safety and efficacy of pimecrolimus. Pediatr Allergy Immunol. 2021;32:414-24. 2. Weidinger S et al. Atopic dermatitis. Lancet. 2016;387:1109-22. 3. EMC. Elidel® SmPC. 2022. Avaliable at: https://www.medicines.org.uk/emc/ product/4966/smpc#gref. Last accessed: 28 January 2026. 4. EMC. Protopic® SmPC. 2021. Avaliable at: https://www.medicines.org.uk/emc/ product/1608/smpc#gref. Last accessed: 28 January 2026.
Question 3: Which of the following statements are NOT correct?
TCIs are not recommended in infants as they cause skin atrophy
AD in infants results in a considerable burden on patients and their families
There are only a few TCS approved for the treatment of infantile AD
Pruritic erythematous inflammatory plaques involving the neck folds and antecubital region are typical for infantile AD
9/17
1. Luger T et al. Unmet medical needs in the treatment of atopic dermatitis in infants: an expert consensus on safety and efficacy of pimecrolimus. Pediatr Allergy Immunol. 2021;32:414-24. 2. Weidinger S et al. Atopic dermatitis. Lancet. 2016;387:1109-22.
How to Apply This in Practice?
Learn more about the treatment algorithm
10/17
According to EU expert recommendations in a new practical algorithm for the management of mild-to-moderate AD in paediatric patients, pimecrolimus is advised for use in moderate AD in infants. It may be initiated at the first signs and symptoms of AD.
Algorithm for the Treatment of Mild Atopic Dermatitis in Paediatric Patients
The EU experts recommended the use of pimecrolimus:1 at initial signs and symptoms of AD to treat acute flares, before resorting to TCS
Learn more about the treatment for moderate AD in paediatric patients
Learn more about the treatment for mild AD in paediatric patients
Pimecrolimus* twice daily to affected areas until signs and symptoms of AD disappear
Emollients as required
AND
Infants (>3 months old), children, and sensitive skin areas (any age)
Acute flares
*Pimecrolimus 1% cream is indicated for treatment of mild-to-moderate AD in infants aged ≥3 months. Acute flare is defined as a clinically significant worsening of signs and symptoms of AD requiring therapeutic intervention.
Algorithm for the Treatment of Moderate Atopic Dermatitis in Paediatric Patients
Infants (>3 months old)
Low-to-moderate TCS to control the acute flare
THEN
Infants (≥3 months old)
Children (≥2 years old)
Sensitive skin areas
TCI† twice daily to affected areas until signs and symptoms of AD disappear
Pimecrolimus‡ twice daily to affected areas until signs and symptoms of AD disappear
Sensitive skin areas (any age)
The EU experts considered that pimecrolimus tended to have a greater effect on the head/neck versus tacrolimus ointment and is more suitable to be used on sensitive facial skin.1
*Pimecrolimus 1% cream is indicated for treatment of mild-to-moderate AD in infants aged ≥3 months. †Pimecrolimus1% cream from age ≥3 months; tacrolimus 0.03% ointment from age 2–15 years. ‡Pimecrolimus is recommended as a first-line treatment of mild-to-moderate AD in the 2022 European guidelines. Acute flare is defined as a clinically significant worsening of signs and symptoms of AD requiring therapeutic intervention.
11/17
1. Augustin M et al. A practical algorithm for the treatment of mild-to-moderate atopic dermatitis (AD) in paediatric patients in Europe: expert recommendations. J Dermatolog Treat. 2025;36(1):2503281.
Question 4: According to the 2025 EU Treatment Algorithm published by Augustin et al.,1 when is pimecrolimus use recommended in infants with mild AD? (select all that apply)
To treat acute flares, after treating with TCS
At initial signs and symptoms
After signs and symptoms have repeatedly flared up
To treat acute flares, before treating with TCS
12/17
Treatment Timeline
The patient was prescribed pimecrolimus 1% cream, to be applied twice daily to the neck. The elbow was treated with moisturisers only.
The caregiver was advised to avoid potential triggers and use a gentle moisturiser regularly.
No systemic treatments were initiated as the condition was localised.
Treatment duration was planned for 4 weeks with follow-up every 2 weeks.
13/17
2 Weeks Post-Treatment
2 weeks after treatment initiation:
Neck (treated with pimecrolimus): marked clinical improvement, with near-complete resolution of erythema and inflammation.
Next steps:
Elbow (treated with moisturisers): the affected area worsened clinically.
The treatment was continued without modification.
Treatment with pimecrolimus was started.
14/17
4 Weeks Post-Treatment
4 weeks after treatment initiation:
Neck (treated with pimecrolimus): complete clinical resolution, with normalisation of skin appearance. No treatment-related adverse events were observed.
Pimecrolimus was stopped, and maintenance with moisturisers was advised.
15/17
Elbow (treated with pimecrolimus): marked clinical improvement, with reduction in erythema and inflammation.
Compare and Contrast: Baseline Versus After Treatment
Baseline
2-week follow-up
4-week follow-up
Treated with PIM
Treated with moisturisers
16/17
Treated with pimecrolimus
Take Home Messages
Pimecrolimus 1% cream was effective and well-tolerated in this infant with AD. Pimecrolimus is the only TCI approved for use in infants with AD. This case highlights the role of steroid-sparing approaches in the management of AD in infants.
17/17
