Randomized double-blind control trial comparing 0.03% and 0.1% tacrolimus
and 1% hydrocortisone in regards to efficacy and safety of atopic dermatitis
treatment in pediatric population 2-15 years old.1
criteria required 5-60% total body surface area involvement -- classified
as moderate to severe atopic dermatitis.
Exclusion criteria were serious skin disorders other than atopic dermatitis
requiring treatment or patients with a history of eczema herpeticum.
Other prohibited therapies during the study were topical and systemic
corticosteroids, antimicrobials and antihistamines, coal tar, topical
NSAIDS, nonsteroidal immunosuppressants, UV light treatments, sedatives,
or other investigational drugs.
patients were randomized into one of three treatment groups: 0.03% tacrolimus,
0.1% tacrolimus, or 1% hydrocortisone. Patient demographics and baseline
characteristics similar across treatment groups including most patients
having active disease on face and neck; however, the hydrocortisone
group did have a longer duration of current episode than either tacrolimus
treatment group (question of more treatment resistant atopic dermatitis).
involved a thin layer of ointment applied twice daily to actively diseased
areas and treatment was to be stopped 7 days after clearance.
based on mEASI (modified eczema area and severity index) which was calculated
using erythema, edema-induration-papulation, excoriations, lichenification,
total body surface area affected, and patient rated intensity of itching.
rates in 0.3% tacrolimus was a median improvement of 55.2%, in 0.1%
tacrolimus was 60.2% and in 1% hydrocortisone was 36%. Separate analysis
of head and neck showed respective improvements of 62.5% (0.3% tacrolimus),
75.2% (0.1% tacrolimus), and 43.3% (1% hydrocortisone).
tacrolimus levels were never as high as 5ng/ml indicating minimal systemic
treatment groups showed higher incidence of transient skin burning.
treatment groups showed significant rates of relapse 2 weeks after discontinuation
of therapy (only half of the patients maintained a moderate improvement
after 2 weeks without therapy).