Efficacy of Protopic in Pediatric patients
Extensively Studied
Protopic Ointment has been studied in worldwide clinical studies with more than 20,000 eczema patients, including 8,000 children with eczema.4 The studies were uniquely focused on patients with more severe cases of atopic dermatitis (AD), with no steroid rescue allowed.
Pivotal Study Design
A 12-week, randomized, double-blind, comparative study was conducted with a total of 351 pediatric eczema patients aged 2 to 15 years of age. Two hundred thirty-three patients were treated with unmedicated vehicle (n=116) or Protopic Ointment 0.03% (n = 117) applied twice daily. Sixty-two percent of patients treated with Protopic Ointment 0.03% had severe AD, and 38% had moderate AD. The mean body surface area (BSA) affected for eczema patients treated with Protopic Ointment 0.03% was 46%, with a range from 10% to 100%.2
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.
Important Safety Information
The most common adverse events associated with the use of Protopic included the sensation of skin burning, pruritus, flu-like symptoms, and headache.
WARNING: Long-term safety of topical calcineurin inhibitors has not been established. Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors (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
- Protopic is not indicated for use in children less than 2 years of age. Only Protopic Ointment 0.03% is indicated for use in children 2 to 15 years of age