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

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01301508
• Other study ID #: AN2898-AD-202
• Secondary ID: C3471001
• Status: Completed
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: November 11, 2011

Study information

• Verified date: February 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 11, 2011
• Est. primary completion date: November 11, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• AN2728 ointment, 2%
AN2728 ointment, 2%, applied twice daily for 6 weeks
• AN2898 ointment, 1%
AN2898 ointment, 1%, applied twice daily for 6 weeks
• AN2898 ointment vehicle
AN2898 ointment vehicle applied twice daily for 6 weeks
• AN2728 ointment vehicle
AN2728 ointment vehicle applied twice daily for 6 weeks

Locations

Country	Name	City	State
Australia	Anacor Investigational Site	Adelaide	South Australia
Australia	Anacor Investigational Site	Box Hill	Victoria
Australia	Anacor Investigational Site	Brisbane	Queensland
Australia	Anacor Investigational Site	Carlton	Victoria
Australia	Anacor Investigational Site	Clayton	Victoria
Australia	Anacor Investigational Site	Fitzroy	Victoria
Australia	Anacor Investigational Site	Fremantle	Western Australia
Australia	Anacor Investigational Site	Kogarah	New South Wales
Australia	Anacor Investigational Site	Nedlands	Western Australia
Australia	Anacor Investigational Site	Parkville	Victoria
Australia	Anacor Investigational Site	Subiaco	Western Australia
Australia	Anacor Investigational Site	Victoria Park	Western Australia
Australia	Anacor Investigational Site	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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