180 children between the ages of 7 and 16 with 5 to 30 % body
surface area involvement of atopic dermatitis were randomized
to receive twice a day applications of either tacrolimus ointment
at 1 of 3 concentrations-0.03 % (n=43), 0.1% ( n=49), 0.3% (n=44),
or vehicle (propylene carbonate, white wax, mineral oil, and petrolatum)
for 22 days with a two week follow up period.1
Patients had to stop topical corticosteroids for one week, and
systemic corticosteroids for six weeks. Patients receiving immunotherapy
or phototherapy had to stop at least one month before enrollment.
Patients were randomized to one of the four treatment arms. The
study was blinded-all tubes of medication looked the same.
Eighteen of the 180 patients discontinued treatment early; 7 in
the vehicle group, 2 in 0.03% tacrolimus group, 5 in the 0.1%
group, and 4 in the 0.3 % group. 4 of the 7 patients in the vehicle
group and one patient in the tacrolimus group discontinued treatment
because of perceived lack of efficacy, 2 of 44 and 5 of 136 discontinued
treatment because of adverse events and noncompliance accounted
for 1 patient in the vehicle group and 5 in the tacrolimus groups.
Outcomes were assessed by the Physicians' Global evaluation of
clinical response, modified Eczema Severity Index, Head and Neck
Total Score, and patient's assessment to overall treatment.
Blood levels monitored on days 0, 4 and 22. Highest level noted
was 2.66 ng/ml, most under 1 ng/ml.
Using the Physicians' Global Evaluation of Clinical Response (greater
than 75 % improvement), 69% CI 53-82% (0.03%), 67% CI 52-81% (0.1%),
70% CI 54-83% (0.3%), and 38% CI 24-54 (vehicle) reported a response.
Estimating the control event rate at 62% (those that did not see
a response in the vehicle group), the EER is 30%, the RRR 52%
with a ARR of 32% and NNT of 3.