Format

Send to

Choose Destination
J Am Acad Dermatol. 2016 Sep;75(3):494-503.e6. doi: 10.1016/j.jaad.2016.05.046. Epub 2016 Jul 11.

Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults.

Author information

1
Northwestern University, Feinberg School of Medicine, Chicago, Illinois. Electronic address: APaller@nm.org.
2
Rady Children's Hospital-San Diego, San Diego, California; University of California, San Diego, La Jolla, California.
3
Icahn School of Medicine at Mount Sinai, New York, New York.
4
Anacor Pharmaceuticals, Inc, Palo Alto, California.
5
National Jewish Health, Denver, Colorado; University of Colorado School of Medicine, Denver, Colorado.
6
Clinical Research Partners, Richmond, Virginia.
7
Jordan Valley Dermatology and Research Center, West Jordan, Utah.
8
Pi-Coor Clinical Research, Burke, Virginia.
9
Oregon Health and Science University, Portland, Oregon.
10
Henry Ford Health System, Detroit, Michigan.
11
Pennsylvania State University, Hershey, Pennsylvania.
12
University of Texas Health Science Center Houston, Houston, Texas.

Erratum in

Abstract

BACKGROUND:

Additional topical treatments for atopic dermatitis (AD) are needed that provide relief while minimizing risks.

OBJECTIVE:

We sought to assess the efficacy and safety of crisaborole ointment, a phosphodiesterase 4 inhibitor, in two phase III AD studies (AD-301: NCT02118766; AD-302: NCT02118792).

METHODS:

Two identically designed, vehicle-controlled, double-blind studies enrolled and randomly assigned (2:1, crisaborole:vehicle) patients aged 2 years or older with an Investigator's Static Global Assessment (ISGA) score of mild or moderate for twice-daily application for 28 days. The primary end point was ISGA score at day 29 of clear (0)/almost clear (1) with 2-grade or greater improvement from baseline. Additional analyses included time to success in ISGA score, percentage of patients achieving clear/almost clear, reduction in severity of AD signs, and time to improvement in pruritus.

RESULTS:

More crisaborole- than vehicle-treated patients achieved ISGA score success (clear/almost clear with ≥2-grade improvement; AD-301: 32.8% vs 25.4%, P = .038; AD-302: 31.4% vs 18.0%, P < .001), with a greater percentage with clear/almost clear (51.7% vs 40.6%, P = .005; 48.5% vs 29.7%, P < .001). Crisaborole-treated patients achieved success in ISGA score and improvement in pruritus earlier than those treated with vehicle (both P ≤ .001). Treatment-related adverse events were infrequent and mild to moderate in severity.

LIMITATIONS:

Short study duration was a limitation.

CONCLUSIONS:

Crisaborole demonstrated a favorable safety profile and improvement in all measures of efficacy, including overall disease severity, pruritus, and other signs of AD.

KEYWORDS:

atopic dermatitis; crisaborole ointment; eczema; phosphodiesterase 4; pruritus; topical therapy

PMID:
27417017
DOI:
10.1016/j.jaad.2016.05.046
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center