PMID- 26461821
OWN - NLM
STAT- MEDLINE
DCOM- 20160906
LR  - 20220316
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 14
IP  - 10
DP  - 2015 Oct
TI  - Crisaborole Topical Ointment, 2% in Adults With Atopic Dermatitis: A Phase 2a, 
      Vehicle-Controlled, Proof-of-Concept Study.
PG  - 1108-12
AB  - BACKGROUND: A novel approach for treating atopic dermatitis (AD) is the 
      inhibition of phosphodiesterase 4 (PDE4), an enzyme involved in the 
      proinflammatory cascade. Crisaborole topical ointment, 2% is a novel, boron-based 
      small-molecule PDE4 inhibitor with anti-inflammatory properties. The objective of 
      this proof-of-concept study was to assess the efficacy and safety of crisaborole 
      topical ointment, 2% in adults with mild to moderate AD. METHODS: This phase 2a, 
      randomized, double-blind, bilateral, 6-week study of crisaborole topical 
      ointment, 2% was conducted in adult patients with mild to moderate AD with 2 
      comparable target AD lesions. Patients were randomly assigned to twice-daily 
      application of crisaborole topical ointment, 2% or vehicle, each to 1 of the 2 
      target lesions. The primary efficacy endpoint was change from baseline in Atopic 
      Dermatitis Severity Index (ADSI) score at day 28. Safety assessments included 
      local tolerability and incidence of adverse events (AEs). RESULTS: A total of 25 
      enrolled patients received study medication. At day 28, 17 patients (68%) 
      experienced a greater decrease in ADSI score in the active-treated lesion than in 
      the vehicle-treated lesion; 5 patients (20%) had a greater decrease in ADSI score 
      in the vehicle-treated lesion than in the active-treated lesion. Local 
      application-site reactions were reported in 3 patients (12%). A total of 29 AEs 
      were reported in 11 patients; most (90%) were mild in intensity and unrelated to 
      study medication. No serious or severe AEs were reported, and no patient 
      discontinued due to an AE. CONCLUSIONS: These findings provide preliminary 
      evidence of the efficacy and safety of treatment with crisaborole topical 
      ointment, 2% in adults with mild to moderate AD. The study is registered on 
      ClinicalTrials.gov (identifier NCT01301508).
FAU - Murrell, Dedee F
AU  - Murrell DF
FAU - Gebauer, Kurt
AU  - Gebauer K
FAU - Spelman, Lynda
AU  - Spelman L
FAU - Zane, Lee T
AU  - Zane LT
LA  - eng
SI  - ClinicalTrials.gov/NCT01301508
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Boron Compounds)
RN  - 0 (Bridged Bicyclo Compounds, Heterocyclic)
RN  - 0 (Dermatologic Agents)
RN  - Q2R47HGR7P (crisaborole)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adult
MH  - Aged
MH  - Boron Compounds/administration & dosage/adverse effects/*therapeutic use
MH  - Bridged Bicyclo Compounds, Heterocyclic/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Dermatitis, Atopic/*drug therapy/pathology
MH  - Dermatologic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Severity of Illness Index
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2015/10/16 06:00
MHDA- 2016/09/07 06:00
CRDT- 2015/10/14 06:00
PHST- 2015/10/14 06:00 [entrez]
PHST- 2015/10/16 06:00 [pubmed]
PHST- 2016/09/07 06:00 [medline]
AID - S1545961615P1108X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2015 Oct;14(10):1108-12.