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

NCT01301508 | Completed Phase 2 Results

• 2 other identifiers: AN2898-AD-202C3471001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 13

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).

Conditions

Dermatitis, Atopic

Keywords

atopic dermatitis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 14 and 42

  Baseline (Day 1), Day 14, Day 42

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline (Day 1) up to Day 42

Study Arms (2)

AN2898 ointment, 1%, vs. ointment vehicle

EXPERIMENTAL

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%; Drug: AN2898 ointment vehicle

AN2728 ointment, 2%, vs. ointment vehicle

EXPERIMENTAL

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%; Drug: AN2728 ointment vehicle

Interventions

AN2728 ointment, 2% DRUG

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

AN2728 ointment, 2%, vs. ointment vehicle

AN2898 ointment, 1% DRUG

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

AN2898 ointment, 1%, vs. ointment vehicle

AN2898 ointment vehicle DRUG

AN2898 ointment vehicle applied twice daily for 6 weeks

AN2898 ointment, 1%, vs. ointment vehicle

AN2728 ointment vehicle DRUG

AN2728 ointment vehicle applied twice daily for 6 weeks

AN2728 ointment, 2%, vs. ointment vehicle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (13)

Anacor Investigational Site

Kogarah, New South Wales, 2217, Australia

Location

Anacor Investigational Site

Brisbane, Queensland, 4000, Australia

Location

Anacor Investigational Site

Woolloongabba, Queensland, 4102, Australia

Location

Anacor Investigational Site

Adelaide, South Australia, 5000, Australia

Location

Anacor Investigational Site

Box Hill, Victoria, 3128, Australia

Location

Anacor Investigational Site

Carlton, Victoria, 3053, Australia

Location

Anacor Investigational Site

Clayton, Victoria, 3168, Australia

Location

Anacor Investigational Site

Fitzroy, Victoria, 3065, Australia

Location

Anacor Investigational Site

Parkville, Victoria, 3050, Australia

Location

Anacor Investigational Site

Fremantle, Western Australia, 6160, Australia

Location

Anacor Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

Anacor Investigational Site

Subiaco, Western Australia, 6008, Australia

Location

Anacor Investigational Site

Victoria Park, Western Australia, 6100, Australia

Location

Related Publications (1)

• 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.

  PMID: 26461821 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 23, 2011
• Study Start: May 1, 2011
• Primary Completion: November 11, 2011
• Study Completion: November 11, 2011
• Last Updated: February 22, 2019
• Results First Posted: March 7, 2017

Record last verified: 2019-02

Locations

AU (13)