NCT01301508 - Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

46

Conditions

Dermatitis, Atopic

Interventions

AN2728 ointment, 2%DRUG

AN2728 ointment, 2%, applied twice daily for 6 weeks

AN2898 ointment, 1%DRUG

AN2898 ointment, 1%, applied twice daily for 6 weeks

AN2898 ointment vehicleDRUG

AN2898 ointment vehicle applied twice daily for 6 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (13)

Anacor Investigational Site

Kogarah, New South Wales, Australia

Anacor Investigational Site

Brisbane, Queensland, Australia

Anacor Investigational Site

Woolloongabba, Queensland, Australia

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.