Announcing the new book by DermNet NZ

Download a FREE sample chapter

DOWNLOAD NOW

Key clinical-trial evidence for crisaborole

Author: Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK). 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 1,522 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.

Major trials supporting clinical efficacy of crisaborole

See below to view Table 1 and Table 2:

View Table 1

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%

View Table 2

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)

Next steps with crisaborole 

Related information

Make a donation

Donate Today

Help us to update and maintain DermNet New Zealand

Submit your images

We are expanding our image library

Contact us

History of DermNet NZ

Watch Dr Amanda Oakley presenting 'The History Of DermNet NZ' at The International Society Of Teledermatology.

Subscribe to our mailing list

* indicates required
DermNet NZ Newsletter