Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis

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

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).

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: AN2898 ointment, 1%; Drug: AN2898 ointment vehicle; Drug: AN2728 ointment, 2%; Drug: AN2728 ointment vehicle

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Anacor Investigational Site
  • Queensland
    • Brisbane, Queensland, Australia, 4000
      • Anacor Investigational Site
    • Woolloongabba, Queensland, Australia, 4102
      • Anacor Investigational Site
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Anacor Investigational Site
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Anacor Investigational Site
    • Carlton, Victoria, Australia, 3053
      • Anacor Investigational Site
    • Clayton, Victoria, Australia, 3168
      • Anacor Investigational Site
    • Fitzroy, Victoria, Australia, 3065
      • Anacor Investigational Site
    • Parkville, Victoria, Australia, 3050
      • Anacor Investigational Site
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Anacor Investigational Site
    • Nedlands, Western Australia, Australia, 6009
      • Anacor Investigational Site
    • Subiaco, Western Australia, Australia, 6008
      • Anacor Investigational Site
    • Victoria Park, Western Australia, Australia, 6100
      • Anacor Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AN2898 ointment, 1%, vs. ointment vehicle; AN2898 ointment applied twice daily for 6 weeks to one target lesion, and AN2898 ointment vehicle applied twice daily for 6 weeks to a second target lesion. Treatments will be randomly assigned to target lesions A and B.	Drug: AN2898 ointment, 1%; AN2898 ointment, 1%, applied twice daily for 6 weeks; Drug: AN2898 ointment vehicle; AN2898 ointment vehicle applied twice daily for 6 weeks
Experimental: AN2728 ointment, 2%, vs. ointment vehicle; AN2728 ointment applied twice daily for 6 weeks to one target lesion, and AN2728 ointment vehicle applied twice daily for 6 weeks to a second target lesion. Treatments will be randomly assigned to target lesions A and B.	Drug: AN2728 ointment, 2%; AN2728 ointment, 2%, applied twice daily for 6 weeks; Drug: AN2728 ointment vehicle; AN2728 ointment vehicle applied twice daily for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)	ADSI score was used to measure the severity of participant's atopic dermatitis (AD) affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.	Baseline (Day 1)
Atopic Dermatitis Severity Index (ADSI) Score at Day 14	ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.	Day 14
Atopic Dermatitis Severity Index (ADSI) Score at Day 28	ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.	Day 28
Atopic Dermatitis Severity Index (ADSI) Score at Day 42	ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.	Day 42
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28	ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Day 28 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Day 28 as compared to active lesion (ointment treated) were reported in this outcome measure.	Baseline (Day 1), Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 14 and 42	ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Days 14, 42 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Days 14, 42 as compared to active lesion (ointment treated) were reported in this outcome measure.	Baseline (Day 1), Day 14, Day 42
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of study medication and up to the end of study treatment (Day 42) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.	Baseline (Day 1) up to Day 42

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 11, 2011
• Study Completion (Actual): November 11, 2011

Study Registration Dates

• First Submitted: February 17, 2011
• First Submitted That Met QC Criteria: February 21, 2011
• First Posted (Estimate): February 23, 2011

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: atopic dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: AN2898-AD-202; C3471001 (Other Identifier: Pfizer)