Dermatitis, AtopicPhase 2NCT01301508

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

A Phase 2 study testing AN2728 ointment, 2% and AN2898 ointment, 1% in people with Dermatitis, Atopic, run by Pfizer at 13 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Dermatitis, Atopic
What is being tested?: AN2728 ointment, 2% and AN2898 ointment, 1%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 13 sitesAustralia
Study dates: May 2011to 11 Nov 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

Australia13 sites

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

Other trials in Australia

About this study

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

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
Being tested: AN2728 ointment, 2%, AN2898 ointment, 1%, AN2898 ointment vehicle, AN2728 ointment vehicle
Keywords: atopic dermatitis
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
AN2728 ointment vehicleDrug
AN2728 ointment vehicle applied twice daily for 6 weeks

Study groups in NCT01301508
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: AN2728 ointment, 2%; Drug: AN2728 ointment vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1), Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201111 Nov 2011

First posted23 Feb 2011 (estimated)
Study startMay 2011
Primary completion11 Nov 2011
Study completion11 Nov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01301508
Sponsor's protocol ID: AN2898-AD-202
Other IDs: C3471001
Status last verified: Feb 2019
First submitted: 17 Feb 2011
Last updated: 22 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 26461821

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dermatitis, Atopic trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01301508
Acronym / sponsor ID: AN2898-AD-202
Conditions: Dermatitis, Atopic
Keywords: atopic dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: 11 Nov 2011 (actual)
Study completion: 11 Nov 2011 (actual)
First posted: 23 Feb 2011 (estimated)
Results: Posted 7 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
AN2898 ointment, 1%, vs. ointment vehicle	Experimental	Drug: AN2898 ointment, 1%, Drug: AN2898 ointment vehicleAN2898 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	Experimental	Drug: AN2728 ointment, 2%, Drug: AN2728 ointment vehicleAN2728 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AN2728 ointment, 2%AN2728 ointment, 2%, applied twice daily for 6 weeks	Drug	AN2728 ointment, 2%, vs. ointment vehicle
AN2898 ointment, 1%AN2898 ointment, 1%, applied twice daily for 6 weeks	Drug	AN2898 ointment, 1%, vs. ointment vehicle
AN2898 ointment vehicleAN2898 ointment vehicle applied twice daily for 6 weeks	Drug	AN2898 ointment, 1%, vs. ointment vehicle
AN2728 ointment vehicleAN2728 ointment vehicle applied twice daily for 6 weeks	Drug	AN2728 ointment, 2%, vs. ointment vehicle

Primary outcome

Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)
Time frame: 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 14
Time frame: 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.
Atopic Dermatitis Severity Index (ADSI) Score at Day 28
Time frame: 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
Time frame: 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.
Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28
Time frame: 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.

Results and safety

Results posted to the registry on 7 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AN2898 Ointment, 1% + Ointment Vehicle	21	20
AN2728 Ointment, 2% + Ointment Vehicle	25	22

Primary outcome: Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)

Time frame: Baseline (Day 1). Mean (Standard Deviation). Unit: units on a scale

Measure	AN2898 Ointment, 1% + Ointment Vehicle n = 21	AN2728 Ointment, 2% + Ointment Vehicle n = 25
Active Lesion	8.0 (1.21)	8.3 (1.77)
Vehicle Lesion	8.0 (1.24)	8.4 (1.75)

Population analysed: The intent-to-treat (ITT) population included all randomized participants who received study medication.

Primary outcome: Atopic Dermatitis Severity Index (ADSI) Score at Day 14

Time frame: Day 14. Mean (Standard Deviation). Unit: units on a scale

Measure	AN2898 Ointment, 1% + Ointment Vehicle n = 21	AN2728 Ointment, 2% + Ointment Vehicle n = 25
Active Lesion	3.8 (1.98)	4.0 (2.54)
Vehicle Lesion	5.4 (2.73)	5.6 (3.17)

Population analysed: ITT population included all randomized participants who received study medication.

Primary outcome: Atopic Dermatitis Severity Index (ADSI) Score at Day 28

Time frame: Day 28. Mean (Standard Deviation). Unit: units on a scale

Measure	AN2898 Ointment, 1% + Ointment Vehicle n = 21	AN2728 Ointment, 2% + Ointment Vehicle n = 25
Active Lesion	2.6 (1.78)	2.8 (2.30)
Vehicle Lesion	4.3 (3.54)	5.1 (3.33)

Population analysed: ITT population included all randomized participants who received study medication.

Primary outcome: Atopic Dermatitis Severity Index (ADSI) Score at Day 42

Time frame: Day 42. Mean (Standard Deviation). Unit: units on a scale

Measure	AN2898 Ointment, 1% + Ointment Vehicle n = 21	AN2728 Ointment, 2% + Ointment Vehicle n = 25
Active Lesion	3.5 (3.75)	3.0 (2.98)
Vehicle Lesion	3.1 (3.12)	4.6 (3.57)

Population analysed: ITT population included all randomized participants who received study medication.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AN2898 Ointment, 1% + Ointment Vehicle	0 of 21 (0%)	11 of 21 (52.4%)	Not reported
AN2728 Ointment, 2% + Ointment Vehicle	0 of 25 (0%)	11 of 25 (44%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26461821Murrell 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AN2728 ointment, 2% and AN2898 ointment, 1% in people with Dermatitis, Atopic, run by Pfizer at 13 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) (time frame: Baseline (Day 1)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01301508, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.