Adult Eczema Studies
Protopic Ointment Extensively Studied
Protopic has been studied in worldwide clinical studies with more than 20,000 eczema patients, including 8,000 children.4 The studies were unique in that they focused on patients with moderate to severe atopic dermatitis, and no steroid rescue was allowed.
Pivotal Study Design
Two 12-week, randomized, double-blind, comparative studies with a total of 632 patients 15 to 79 years of age were conducted. Four hundred twenty-one eczema patients were treated with unmedicated vehicle (n=212) or Protopic Ointment 0.1% (n=209) applied twice daily. Fifty-nine percent of patients treated with Protopic Ointment 0.1% had severe AD, and 41% had moderate AD.1
Defining Success
Success was defined as a rating of “Cleared” or “Excellent Improvement” (at least 90%) at the end of treatment. Efficacy was also evaluated based on the patient’s assessment of pruritus, the physician’s evaluation of clinical signs of AD, the percentage of BSA affected, the total score, and the Eczema Area Severity Index (EASI) score.
Long-term Safety Study Design
An open-label, non-comparative study was conducted with 6 to 12 months of follow-up. The study enrolled 316 patients aged 18 years and older (200 for 6 months, 116 for 12 months). Eczema patients were treated with Protopic Ointment 0.1% applied twice daily. Fifty-three percent of patients had severe AD, and 47% had moderate AD.6
Important Safety Information
WARNING: Long-term safety of topical calcineurin inhibitors (TCIs) has not been established (beyond 1 year of non-continuous use). Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with TCIs, including Protopic. Therefore, continuous long-term use of TCIs, including Protopic, in any age group should be avoided and application limited to areas of involvement with AD. The diagnosis of AD should be confirmed if signs and symptoms do not improve within 6 weeks.