Dermatitis, AtopicPhase 2NCT01602341

Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis

A Phase 2 study testing AN2728 Topical Ointment, 2% QD, AN2728 Topical Ointment, 0.5% QD and AN2728 Topical Ointment, 2% BID in people with Dermatitis, Atopic, run by Pfizer at 17 sites in 2 countries.

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 the safety and efficacy of AN2728 Topical Ointment, 2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of adolescents with atopic dermatitis (AD) Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Dermatitis, Atopic
What is being tested?: AN2728 Topical Ointment, 2% QD, AN2728 Topical Ointment, 0.5% QD and AN2728 Topical Ointment, 2% BID
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 17 sitesin 2 countries
Study dates: Aug 2012to Jan 2013
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 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female 12 to 17 years of age, inclusive
Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and Rajka)
Total body surface area (BSA) of atopic dermatitis involvement ≤35%
Presence of two comparable target lesions
Willing and able to comply with study instructions and commit to attending all visits
Females of childbearing potential must use a highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use a highly effective method of birth control during the study.
Parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has the ability to give assent

Who cannot join

Significant confounding conditions as assessed by study doctor
Unstable or actively infected AD
Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within the last 5 years

Show all 10Show fewer

Current pregnancy or lactation, or intent to become pregnant during the study
Known sensitivity to any of the components of the study drug
Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
Participated in a previous AN2728 clinical study

Trial locations and contacts

17 sites in 2 countries.

Country

City, postcode or hospital

17 sites in 2 countries

United States11 sites

Anacor Investigational Site
Albuquerque, New Mexico
Anacor Investigational Site
Detroit, Michigan
Anacor Investigational Site
Fremont, California
Anacor Investigational Site
High Point, North Carolina
Anacor Investigational Site
Knoxville, Tennessee
Anacor Investigational Site
Lousiville, Kentucky
Anacor Investigational Site
Miami, Florida
Anacor Investigational Site
Norfolk, Virginia
Anacor Investigational Site
Portland, Oregon
Anacor Investigational Site
Salt Lake City, Utah
Anacor Investigational Site
Stony Brook, New York

Other trials in United States

Australia6 sites

Anacor Investigational Site
Box Hill, Victoria
Anacor Investigational Site
Fremantle, Western Australia, 6160
Anacor Investigational Site
Kogarah, New South Wales, 2217
Anacor Investigational Site
Parkville, Victoria
Anacor Investigational Site
Phillip, Australian Capital Territory, 2606
Anacor Investigational Site
Wooloongabba, Queensland

Other trials in Australia

About this study

Official title: A Multicenter, Randomized, Double-Blind, Four-Week, Bilateral Study of the Safety and Efficacy of Two Concentrations of AN2728 Ointment Administered Once or Twice a Day in Adolescents With Atopic Dermatitis

Conditions: Dermatitis, Atopic
Being tested: AN2728 Topical Ointment, 2% QD, AN2728 Topical Ointment, 0.5% QD, AN2728 Topical Ointment, 2% BID, AN2728 Topical Ointment, 0.5% BID
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 Topical Ointment, 2% QDDrug
AN2728 Topical Ointment, 2% QD
AN2728 Topical Ointment, 0.5% QDDrug
AN2728 Topical Ointment, 0.5% QD
AN2728 Topical Ointment, 2% BIDDrug
AN2728 Topical Ointment, 2% BID
AN2728 Topical Ointment, 0.5% BIDDrug
AN2728 Topical Ointment, 0.5% BID

Study groups in NCT01602341
Study group	Role	What they receive
AN2728 Topical Ointment, 2% QD vs 0.5% QD	Experimental	AN2728 Topical Ointment, 2% applied once daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied once daily for 29 days to a target lesion Treatments will be randomly assigned to target lesions A and B. Receives: Drug: AN2728 Topical Ointment, 2% QD; Drug: AN2728 Topical Ointment, 0.5% QD
AN2728 Topical Ointment, 2% BID vs 0.5% BID	Experimental	AN2728 Topical Ointment, 2% applied twice daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied twice daily for 29 days to a target lesion. Treatments will be randomly assigned to target lesions A and B. Receives: Drug: AN2728 Topical Ointment, 2% BID; Drug: AN2728 Topical Ointment, 0.5% BID

What is being measured

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

Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.
Measured: Baseline, Day 8
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.
Measured: Baseline, Day 15
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.
Measured: Baseline, Day 22
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.
Measured: Baseline, Day 29

Secondary outcomes (6)

Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.
Measured: Baseline up to Day 29
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion.
Measured: Baseline up to Day 29
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 drug without regard to possibility of causal relationship. An SAE is 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/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study treatment (Day 29), that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Baseline up to Day 29
Number of Participants With Treatment-Emergent Adverse Events By Severity
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function. Number of participants with mild, moderate and severe treatment-emergent AEs were reported in this outcome measure.
Measured: Baseline up to Day 29
Number of Participants With Local Tolerability Symptoms
Participants who experienced local tolerability symptoms: mild itching or burning/stinging at sites of study drug application were reported in this measure.
Measured: Baseline up to Day 29
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from baseline was calculated as baseline evaluation minus the follow-up evaluation.
Measured: Baseline, Day 8, 15, 22, 29

Timeline

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

Aug 2012Jan 2013

First posted21 May 2012 (estimated)
Study startAug 2012
Primary completionJan 2013
Study completionJan 2013

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.
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: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01602341
Sponsor's protocol ID: AN2728-AD-204
Status last verified: Jan 2017
First submitted: 17 May 2012
Last updated: 6 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Four-Week, Bilateral Study of the Safety and Efficacy of Two Concentrations of AN2728 Ointment Administered Once or Twice a Day in Adolescents With Atopic Dermatitis
ClinicalTrials.gov ID: NCT01602341
Acronym / sponsor ID: AN2728-AD-204
Conditions: Dermatitis, Atopic
Keywords: atopic dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 21 May 2012 (estimated)
Results: Posted 6 Mar 2017

Clinical summary

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

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
AN2728 Topical Ointment, 2% QD vs 0.5% QD	Experimental	Drug: AN2728 Topical Ointment, 2% QD, Drug: AN2728 Topical Ointment, 0.5% QDAN2728 Topical Ointment, 2% applied once daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied once daily for 29 days to a target lesion Treatments will be randomly assigned to target lesions A and B.
AN2728 Topical Ointment, 2% BID vs 0.5% BID	Experimental	Drug: AN2728 Topical Ointment, 2% BID, Drug: AN2728 Topical Ointment, 0.5% BIDAN2728 Topical Ointment, 2% applied twice daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied twice daily for 29 days to a target lesion. Treatments will be randomly assigned to target lesions A and B.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

Male or female 12 to 17 years of age, inclusive
Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and Rajka)
Total body surface area (BSA) of atopic dermatitis involvement ≤35%
Presence of two comparable target lesions
Willing and able to comply with study instructions and commit to attending all visits

Key exclusion criteria (10 listed)

Significant confounding conditions as assessed by study doctor
Unstable or actively infected AD
Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period

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 Topical Ointment, 2% QDAN2728 Topical Ointment, 2% QD	Drug	AN2728 Topical Ointment, 2% QD vs 0.5% QD
AN2728 Topical Ointment, 0.5% QDAN2728 Topical Ointment, 0.5% QD	Drug	AN2728 Topical Ointment, 2% QD vs 0.5% QD
AN2728 Topical Ointment, 2% BIDAN2728 Topical Ointment, 2% BID	Drug	AN2728 Topical Ointment, 2% BID vs 0.5% BID
AN2728 Topical Ointment, 0.5% BIDAN2728 Topical Ointment, 0.5% BID	Drug	AN2728 Topical Ointment, 2% BID vs 0.5% BID

Primary outcome

Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8
Time frame: Baseline, Day 8
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15
Time frame: Baseline, Day 15
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22
Time frame: Baseline, Day 22
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.
Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29
Time frame: Baseline, Day 29
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.

6 secondary outcomes

Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to Day 29
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time frame: Baseline up to Day 29
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 29
Number of Participants With Treatment-Emergent Adverse Events By Severity
Time frame: Baseline up to Day 29
Number of Participants With Local Tolerability Symptoms
Time frame: Baseline up to Day 29
Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29
Time frame: Baseline, Day 8, 15, 22, 29

Results and safety

Results posted to the registry on 6 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
AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily	44	44
AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily	42	41

Primary outcome: Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8

Time frame: Baseline, Day 8. Mean (Standard Deviation). Unit: units on a scale

Measure	AN2728 Ointment 0.5 Percent, Once Daily n = 44	AN2728 Ointment 2 Percent, Once Daily n = 44	AN2728 Ointment 0.5 Percent, Twice Daily n = 42	AN2728 Ointment 2 Percent, Twice Daily n = 42
Baseline	8.22 (1.891)	8.02 (1.852)	8.13 (1.811)	8.19 (1.811)
Improvement at Day 8	2.80 (2.431)	3.63 (1.695)	4.33 (2.208)	4.81 (1.972)

Population analysed: ITT population included all participants who were randomized and received study drug.

Primary outcome: Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15

Time frame: Baseline, Day 15. Mean (Standard Deviation). Unit: units on a scale

Measure	AN2728 Ointment 0.5 Percent, Once Daily n = 44	AN2728 Ointment 2 Percent, Once Daily n = 44	AN2728 Ointment 0.5 Percent, Twice Daily n = 42	AN2728 Ointment 2 Percent, Twice Daily n = 42
Value	4.02 (2.781)	4.34 (2.394)	4.51 (2.400)	5.36 (2.028)

Population analysed: ITT population included all participants who were randomized and received study drug.

Primary outcome: Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22

Time frame: Baseline, Day 22. Mean (Standard Deviation). Unit: units on a scale

Measure	AN2728 Ointment 0.5 Percent, Once Daily n = 44	AN2728 Ointment 2 Percent, Once Daily n = 44	AN2728 Ointment 0.5 Percent, Twice Daily n = 42	AN2728 Ointment 2 Percent, Twice Daily n = 42
Value	3.86 (3.157)	4.55 (2.551)	4.70 (2.271)	5.49 (1.803)

Population analysed: ITT population included all participants, who were randomized and received study drug.

Primary outcome: Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29

Time frame: Baseline, Day 29. Mean (Standard Deviation). Unit: units on a scale

Measure	AN2728 Ointment 0.5 Percent, Once Daily n = 44	AN2728 Ointment 2 Percent, Once Daily n = 44	AN2728 Ointment 0.5 Percent, Twice Daily n = 42	AN2728 Ointment 2 Percent, Twice Daily n = 42
Value	4.47 (3.185)	5.07 (2.214)	5.06 (2.361)	5.81 (1.714)

Population analysed: ITT population included all participants who were randomized and received study drug.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily	0 of 44 (0%)	6 of 44 (13.6%)	Not reported
AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily	0 of 42 (0%)	11 of 42 (26.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dermatitis, Atopic

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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

17 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 10 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, 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 6 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?

Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8 (time frame: Baseline, Day 8). The study lists 4 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 NCT01602341.

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 6 Mar 2017.