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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) |
If you are not based in New Zealand, we suggest you refer to your national drug approval agency for further information about medicines (eg, the Australian Therapeutic Goods Administration and the US Food and Drug Administration) or a national or state-approved formulary (eg, the New Zealand Formulary and New Zealand Formulary for Children and the British National Formulary and British National Formulary for Children).
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