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

Phase 2

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Drug: AN2898 ointment, 1%; Drug: AN2728 ointment, 2%; Drug: AN2898 ointment vehicle; Drug: AN2728 ointment vehicle

• Registration Number: NCT01301508
• Lead Sponsor: Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-21
• Study First Posted: 2011-02-23
• Study Start: 2011-05
• Primary Completion: 2011-11-11
• Study Completion: 2011-11-11
• Disposition First Submitted: 2012-04-27
• Disposition First Submitted QC: 2012-04-27
• Disposition First Posted: 2012-05-01
• Results First Submitted: 2017-01-11
• Results First Submitted QC: 2017-01-12
• Results First Posted: 2017-03-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AN2898 ointment, 1%, vs. ointment vehicle	AN2898 ointment, 1%	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.
AN2898 ointment, 1%, vs. ointment vehicle	AN2898 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.
AN2728 ointment, 2%, vs. ointment vehicle	AN2728 ointment, 2%	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.
AN2728 ointment, 2%, vs. ointment vehicle	AN2728 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.

Primary Outcome Measures

Name	Time	Method
Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)	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.
Atopic Dermatitis Severity Index (ADSI) Score at Day 28	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.
Atopic Dermatitis Severity Index (ADSI) Score at Day 42	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.
Atopic Dermatitis Severity Index (ADSI) Score at Day 14	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.
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28	Baseline (Day 1), 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.

Trial Locations

Locations (1)

Anacor Investigational Site; 🇦🇺 Victoria Park, Western Australia, Australia