Lee 2014.

Study characteristics
Methods	Trial design: randomised, double‐blind study Trial registration number: not reported Country: South Korea Outpatient or hospital, date trial conducted: not reported Duration of trial participation: up to 4 weeks under double‐blinded, randomised conditions Inclusion criteria: · Presence of AD for greater than 3 months · A lesion covering over 5% of the patient’s body surface area involving the face, head and neck · An IGA score of greater than 2 · Persistent AD lesions despite the use of existing potency class VII or greater TCS for more than two weeks Exclusion criteria: · Inability to receive local formulation treatment due to the presence of an external wound · The presence of other infections, diseases or skin disorders · Treatment with a systemic steroid, systemic immunosuppressant, or oriental herbal medicine within the previous 3 months · General inappropriateness for the study as determined by the clinical trial investigator Additional design details: if clinical improvement was evident within the entire lesion (IGA score ≤ 1) prior to completion of the 4 weeks of treatment, the patients were switched to an open‐label phase. Upon conclusion of the double‐blind phase, a 24‐week extension was initiated to assess long‐term efficacy and safety.
Participants	Total number randomised: 55 participants (28 to apply the intervention and 27 to apply the comparator) Age: pimecrolimus group mean 0.7 years (SD 0.3); desonide group mean 0.7 years (SD 0.5) Sex: pimecrolimus group male n = 17, female n = 11; desonide group male n = 20, female n = 7 Ethnicity: not reported Duration of eczema: more than 3 months Severity of eczema: mean IGA scores (95% confidence interval): pimecrolimus group 3.9 (95% CI 3.5 to 4.2); desonide group 3.6 (95% CI 3.2 to 4.0) Body site: a lesion covering over 5% of the patient’s body surface area involving the face, head and neck Number of withdrawals: one patient lost to follow‐up in the pimecrolimus group Notes: none
Interventions	Run‐in details: study only included participants who still had persistent AD lesions after a washout period of using existing potency class VII or greater topical steroids for more than two weeks Intervention: pimecrolimus 1% cream used twice daily for up to 28 days · Concurrent treatment: not reported · Other key information: none Comparator: desonide 0.05% cream used twice daily for up to 28 days. · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: none Notes: if clinical improvement was evident within the entire lesion (IGA score # 1) prior to completion of the 4 weeks of treatment, the patients were switched to an open‐label phase. In the open‐label phase, all patients applied the corresponding medication to their lesion based on authorisation and off‐label approval if topical administration was required due to the worsening of lesions.
Outcomes	· IGA (0 = clear, 1 = almost clear). Upon achievement of an IGA score of 0 or 1, the patient was switched to the open‐label challenge. · EASI score · Safety assessments consisted of the monitoring and recording of all adverse events as well as dermoscopic assessments of face, head and neck lesions for skin atrophy and telangiectasia · Analysis of endogenous metabolites: haematology, blood chemistry, morning serum cortisol, T cell subset and urinalysis
Notes	Funding source: multiple grants including the KFDA, the Bio‐Synergy Research Project of the Ministry of Science, ICT and Future Planning through the National Research Foundation, the National Research Foundation of Korea grant by the Korean government, Basic Science Research Program through the National Research Foundation of Korea funded by the Ministry of Education, Science and Technology and BK21 Plus Program Declarations of interest: the authors declared no competing financial interests. Original language of publication: English Other: none