Home » Topics A–Z » Key clinical-trial evidence for crisaborole
Author: Anoma Ranaweera, Medical Writer, Auckland, New Zealand. Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, March 2017.
In December 2016, the US Food and Drug Administration (FDA) approved 2% crisaborole topical ointment (EUCRISA™, Anacor Pharmaceuticals, California, USA) to treat mild to moderate atopic dermatitis in patients 2 years of age and older.
The approval of crisaborole was based on results of two large, identical, multicenter, randomised, double-blind, parallel-group, vehicle-controlled (non-medicated ointment) trials (Trials 1 and 2) that treated 1522 patients aged 2–79 years with mild to moderate atopic dermatitis.
Crisaborole is the first and only non-steroidal topical monotherapy for atopic dermatitis that inhibits the phosphodiesterase-4 (PDE-4) enzyme in the skin.
Overactive PDE-4 has been shown to contribute to the signs and symptoms of atopic dermatitis.
Trial 1 |
Trial 2 |
|||
Eucrisa (n = 503) |
Vehicle (n = 256) |
Eucrisa (n = 513) |
Vehicle (n = 250) |
|
Success in IGSA× |
32.8% |
25.4% |
31.4% |
18% |
Event [No. Patients (%)] |
Crisaborole (n = 1012) |
Vehicle (n = 499) |
Treatment-related AE∗ |
||
Application site pain |
45 (4.4) |
6 (1.2) [P=0.0001] |
Treatment-emergent AE |
||
Gastrointestinal disorders |
27 (2.7) |
12 (2.4) |
Application site pruritus |
5 (0.5) |
6 (1.2) |
Pyrexia |
19 (1.9) |
7 (1.4) |
Nasopharyngitis |
18 (1.8) |
6 (1.2) |
Staphylococcal skin infection |
1 (0.1) |
5 (1.0) [P= 0.017] |
Upper respiratory tract infection |
30 (3.0) |
15 (3.0) |
Headache |
11 (1.1) |
1 (0.2) |
Cough |
12 (1.2) |
8 (1.6) |
Skin and subcutaneous tissue disorders |
37 (3.7) |
21 (4.2) |
Dermatitis atopic |
7 (0.7) |
8 (1.6) |
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