Clinical trial NCT01301508: Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis
Official title: A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Bilateral Study of the Safety and Efficacy of Topically Applied AN2898 and AN2728 in the Treatment of Patients With Mild-to-Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Keywords: atopic dermatitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of atopic dermatitis that has been clinically stable for ≥1 month
* Total body surface area (BSA) of atopic dermatitis involvement ≤35%, excluding involvement of the face, scalp, and groin
* Presence of two (2) comparable target lesions
* Willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits
* Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study.

Exclusion Criteria:

* Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
* Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
* Significant confounding conditions as assessed by study doctor
* History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
* Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
* Pregnancy or lactation

Primary outcomes:
measure: Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)
timeFrame: Baseline (Day 1)
measure: Atopic Dermatitis Severity Index (ADSI) Score at Day 14
timeFrame: Day 14
measure: Atopic Dermatitis Severity Index (ADSI) Score at Day 28
timeFrame: Day 28
measure: Atopic Dermatitis Severity Index (ADSI) Score at Day 42
timeFrame: Day 42
measure: Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28
timeFrame: Baseline (Day 1), Day 28
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 14 and 42
timeFrame: Baseline (Day 1), Day 14, Day 42
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline (Day 1) up to Day 42
Locations:
city: Kogarah
country: Australia
facility: Anacor Investigational Site
state: New South Wales
city: Brisbane
country: Australia
facility: Anacor Investigational Site
state: Queensland
city: Woolloongabba
country: Australia
facility: Anacor Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: Anacor Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: Anacor Investigational Site
state: Victoria
city: Carlton
country: Australia
facility: Anacor Investigational Site
state: Victoria
city: Clayton
country: Australia
facility: Anacor Investigational Site
state: Victoria
city: Fitzroy
country: Australia
facility: Anacor Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: Anacor Investigational Site
state: Victoria
city: Fremantle
country: Australia
facility: Anacor Investigational Site
state: Western Australia
city: Nedlands
country: Australia
facility: Anacor Investigational Site
state: Western Australia
city: Subiaco
country: Australia
facility: Anacor Investigational Site
state: Western Australia
city: Victoria Park
country: Australia
facility: Anacor Investigational Site
state: Western Australia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Murrell DF, Gebauer K, Spelman L, Zane LT. Crisaborole Topical Ointment, 2% in Adults With Atopic Dermatitis: A Phase 2a, Vehicle-Controlled, Proof-of-Concept Study. J Drugs Dermatol. 2015 Oct;14(10):1108-12.