Atopic DermatitisPhase 1/2NCT02795832

A Study to Determine the Safety & Efficacy of ZPL-5212372 in Healthy Subjects and in Subjects With Atopic Dermatitis

A Phase 1/2 study testing ZPL-5212372 1% w/w Ointment BID in people with Atopic Dermatitis, run by Ziarco Pharma Ltd at 3 sites in United Kingdom.

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

A Randomised, Adaptive Design, Double-Blind (3rd Party Open), Placebo Controlled, Sequential Group Study to Determine the Safety,Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of a Topical ZPL-5212372 (1.0% w/w) Ointment Administered for up to 2 Weeks in Adult Healthy Volunteers and Patients… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Atopic Dermatitis
What is being tested?: ZPL-5212372 1% w/w Ointment BID
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 53 participants
Where: 3 sitesUnited Kingdom
Study dates: Jun 2016to 1 Mar 2017
Phase: Phase 1/2
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy males or females, aged between 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
or
Males and females aged 18-65 years inclusive with physician documented history or diagnosis of atopic dermatitis for at least 6 months prior to screening. AD should be diagnosed by the Eichenfield revised criteria of Hanifin and Rajka.
For Atopic Dermatitis Patients:
Eczema Area and Severity Index (EASI) of ≥9 and <48 at Screening and an EASI of ≥12 and <48 at Day 1.
An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 1.

Show all 9Show fewer

Atopic dermatitis affecting between ≥10 to <40% BSA at Screening and ≥10% to <50% BSA on Day 1.
All Subjects:
Evidence of a personally signed and dated informed consent form, indicating that the subject has been informed of all pertinent aspects of the study.

Who cannot join

For Healthy Subjects
Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Have tattoos covering areas of skin to be dosed with study ointment.
Subjects who are hirsute in areas of skin to be dosed with study ointment.
Subjects who have received treatment with an investigational drug within 3 months prior to screening.
For Atopic Dermatitis Patients:

Show all 11Show fewer

AD of such severity (EASI >48) that the subject could not comply with the demands of the study and/or the subject is not a suitable candidate for a placebo-controlled study.
Have concomitant skin disease or infection (e.g. acne, impetigo) or presence of skin comorbidities in the study area to be dosed that may interfere with study assessments.
Have received phototherapy (e.g. UVA, UVB or PUVA therapy), or systemic therapy (e.g. immunosuppressants [such as cyclosporine, azathioprine, methotrexate], cytostatics) known or suspected to have an effect on AD, within 4 weeks of the start of the study. All other biologics should not have been used within 3 months of the start of study.
Have received systemic corticosteroids (e.g. oral, intravenous, intraarticular, rectal) within 4 weeks of the start of the study. Subjects on a stable maintenance dose (over the preceding 3 months) of inhaled or intranasal CS may participate.
Patients treated with oral antihistamines or topical calcineurin inhibitors or topical steroids within 7 days of starting study; intranasal antihistamines for the treatment of allergic rhinitis are acceptable.

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

MAC
Blackpool
MAC
Leeds
MAC
Manchester

Other trials in United Kingdom

About this study

Official title: A Randomised, Double-blind, Placebo Controlled Study to Determine the Safety, Pharmacokinetics and Efficacy of Topical ZPL-5212372 Ointment Administered BID for up to 2 Weeks in Healthy Subjects and Subjects With Atopic Dermatitis.

Read the detailed description

This study was a randomised, adaptive design, double blind (3rd party open), placebo controlled, sequential group study in both healthy volunteers and patients with moderate to severe AD. This study was divided into 3 separate, sequential cohorts:

Cohort 1 were to assess safety, toleration and pharmacokinetics (PK) with intensive monitoring as in-patients over 7 days of dosing in healthy volunteers.
Cohort 2 were to assess safety, toleration and PK with intensive monitoring as in-patients over 7 days of dosing in moderate to severe AD patients.
Cohort 3 were to assess efficacy, safety, toleration and PK as out-patients over 14 days of dosing in moderate to severe AD patients.

Subjects received 1.0% (w/w) ZPL-5212372 or matched placebo ointment topically, twice daily.

Conditions: Atopic Dermatitis
Being tested: ZPL-5212372 1% w/w Ointment BID, Placebo Ointment BID
Medical subject headings: Dermatitis, Atopic

What participants receive

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

ZPL-5212372 1% w/w Ointment BIDDrug
Placebo Ointment BIDDrug

Study groups in NCT02795832
Study group	Role	What they receive
Cohort 1a	Experimental	ZPL-5212372 1% w/w Ointment BID Receives: Drug: ZPL-5212372 1% w/w Ointment BID
Cohort 1b	Placebo comparator	Placebo Ointment BID Receives: Drug: Placebo Ointment BID
Cohort 2a	Experimental	ZPL-5212372 1% w/w Ointment BID Receives: Drug: ZPL-5212372 1% w/w Ointment BID
Cohort 2b	Placebo comparator	Placebo Ointment BID Receives: Drug: Placebo Ointment BID
Cohort 3a	Experimental	ZPL-5212372 1% w/w OIntment BID Receives: Drug: ZPL-5212372 1% w/w Ointment BID
Cohort 3b	Placebo comparator	Placebo Ointment BID Receives: Drug: Placebo Ointment BID

What is being measured

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

Percent Change From Baseline in EASI Score in Cohort 3
The EASI is a validated tool used to measure the severity and extent of atopic eczema (Eczema Area and Severity Index). The body is divided into 4 sections of total skin area: head including neck (10%); arms including extremities (20%); trunk (30%) and legs including extremities (40%). Each area is scored and the 4 scores are combined into the final EASI. The severity parameters are measured on a scale of 0 to 3 (from none to severe). For each section, the percentage area of skin involved with eczema is estimated and transformed into an extent grade from 0 to 6, from 0% of involved skin area with eczema to 90-100% of involved skin area with eczema. The sum of all four severity parameters is calculated for each section of skin and then multiplied by the weight of the respective section. This value is then multiplied by the extent score for that body area. The EASI value can range from 0-72, a higher score indicates more severe disease.
Measured: Day 1 and Day 14
Percent Change From Baseline in EASI Score Over Time in Cohort 3 - Observed Case
The EASI is a validated tool used to measure the severity and extent of atopic eczema (Eczema Area and Severity Index). The body is divided into 4 sections of total skin area: head including neck (10%); arms including extremities (20%); trunk (30%) and legs including extremities (40%). Each area is scored and the 4 scores are combined into the final EASI. The severity parameters are measured on a scale of 0 to 3 (from none to severe). For each section, the percentage area of skin involved with eczema is estimated and transformed into an extent grade from 0 to 6, from 0% of involved skin area with eczema to 90-100% of involved skin area with eczema. The sum of all four severity parameters is calculated for each section of skin and then multiplied by the weight of the respective section. This value is then multiplied by the extent score for that body area. The EASI value can range from 0-72, a higher score indicates more severe disease.
Measured: Days 1, 5, 8, 10, and 15

Secondary outcomes (5)

Summary of EASI-50 and EASI-75 Responders at Week 2 - Cohort 3
The proportion of subjects who achieved EASI-50 and EASI-75 responses at Week 2 were compared between treatment groups.
EASI-50 was defined as a ≥50% reduction from baseline in EASI score at Week 2. EASI-75 was defined as a ≥75% reduction from baseline in EASI score at Week 2.
Measured: Day 14
Percentage of Responders on Investigators Global Assessment in Cohort 3
The following secondary endpoints were assessed for IGA:
A subject was considered as having IGA success if they achieved a score of 'Clear' or 'Almost clear'; note, as subjects required a score of ≥3 to enter the study they must have had a reduction of ≥2 from baseline to achieve success A subject was considered as having an IGA response if they achieved a score of 'Clear' or 'Almost clear', or a reduction of ≥2 from baseline IGA was summarized for the FAS with counts and percentages by treatment at each visit.
Measured: Day 14
Change From Baseline in NRS for Pruritus at Week 2 - Observed Case in Cohort 3
Numerical Rating Scale (NRS) for Pruritus (worst itch). The Pruritus NRS is an assessment tool that will be used to assess the subject's worst itch as a result of AD in the previous 24 hours.
They will be asked the following question:
On a scale of 0 (No Itching) to 10 (Itching as bad as you can imagine), please rate the WORST itching that you felt over the last 24 hours.
Measured: Day 1 to day 14
Summary of Patient Global Impression of Change and Logistic Regression of Patient Global Impression of Change in Cohort 3
Patient Global Impression of Change (PGIC) The PGIC scores were summarised for the FAS with counts and percentages in each treatment group. All data collected were included.
The PGIC was dichotomized into responders, defined as responses of 'Very Much Improved', 'Much Improved' or 'Minimally improved' and non-responders (all other responses plus missing data).
Measured: End of treatment (day 15)
Change From Baseline in Body Surface Area at Week 2 - Observed Case in Cohort 3
Body Surface Area (BSA). The percentage BSA affected was summarised at each visit, including change from baseline, by treatment group, using the Full Analysis Set.
Measured: Day 1 to day 14

Timeline

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

Jun 20161 Mar 2017

First posted10 Jun 2016 (estimated)
Study startJun 2016
Primary completion1 Mar 2017
Study completion1 Mar 2017

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 Atopic DermatitisStudies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02795832
Sponsor's protocol ID: Ziarcopharma
Status last verified: Apr 2019
First submitted: 6 Jun 2016
Last updated: 5 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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 Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo Controlled Study to Determine the Safety, Pharmacokinetics and Efficacy of Topical ZPL-5212372 Ointment Administered BID for up to 2 Weeks in Healthy Subjects and Subjects With Atopic Dermatitis.
ClinicalTrials.gov ID: NCT02795832
Acronym / sponsor ID: Ziarcopharma
Conditions: Atopic Dermatitis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Ziarco Pharma LtdIndustry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: 1 Mar 2017 (actual)
Study completion: 1 Mar 2017 (actual)
First posted: 10 Jun 2016 (estimated)
Results: Posted 5 Apr 2019

Clinical summary

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

Detailed description

Cohort 1 were to assess safety, toleration and pharmacokinetics (PK) with intensive monitoring as in-patients over 7 days of dosing in healthy volunteers.
Cohort 2 were to assess safety, toleration and PK with intensive monitoring as in-patients over 7 days of dosing in moderate to severe AD patients.
Cohort 3 were to assess efficacy, safety, toleration and PK as out-patients over 14 days of dosing in moderate to severe AD patients.

Subjects received 1.0% (w/w) ZPL-5212372 or matched placebo ointment topically, twice daily.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Cohort 1a	Experimental	Drug: ZPL-5212372 1% w/w Ointment BIDZPL-5212372 1% w/w Ointment BID
Cohort 1b	Placebo comparator	Drug: Placebo Ointment BIDPlacebo Ointment BID
Cohort 2a	Experimental	Drug: ZPL-5212372 1% w/w Ointment BIDZPL-5212372 1% w/w Ointment BID
Cohort 2b	Placebo comparator	Drug: Placebo Ointment BIDPlacebo Ointment BID
Cohort 3a	Experimental	Drug: ZPL-5212372 1% w/w Ointment BIDZPL-5212372 1% w/w OIntment BID
Cohort 3b	Placebo comparator	Drug: Placebo Ointment BIDPlacebo Ointment BID

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Healthy males or females, aged between 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
or
Males and females aged 18-65 years inclusive with physician documented history or diagnosis of atopic dermatitis for at least 6 months prior to screening. AD should be diagnosed by the Eichenfield revised criteria of Hanifin and Rajka.
Eczema Area and Severity Index (EASI) of ≥9 and <48 at Screening and an EASI of ≥12 and <48 at Day 1.
An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 1.

Key exclusion criteria (11 listed)

For Healthy Subjects
Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Have tattoos covering areas of skin to be dosed with study ointment.
Subjects who are hirsute in areas of skin to be dosed with study ointment.
Subjects who have received treatment with an investigational drug within 3 months prior to screening.

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
ZPL-5212372 1% w/w Ointment BID	Drug	Cohort 1a, Cohort 2a, Cohort 3a
Placebo Ointment BID	Drug	Cohort 1b, Cohort 2b, Cohort 3b

Primary outcome

Percent Change From Baseline in EASI Score in Cohort 3
Time frame: Day 1 and Day 14
The EASI is a validated tool used to measure the severity and extent of atopic eczema (Eczema Area and Severity Index). The body is divided into 4 sections of total skin area: head including neck (10%); arms including extremities (20%); trunk (30%) and legs including extremities (40%). Each area is scored and the 4 scores are combined into the final EASI. The severity parameters are measured on a scale of 0 to 3 (from none to severe). For each section, the percentage area of skin involved with eczema is estimated and transformed into an extent grade from 0 to 6, from 0% of involved skin area with eczema to 90-100% of involved skin area with eczema. The sum of all four severity parameters is calculated for each section of skin and then multiplied by the weight of the respective section. This value is then multiplied by the extent score for that body area. The EASI value can range from 0-72, a higher score indicates more severe disease.
Percent Change From Baseline in EASI Score Over Time in Cohort 3 - Observed Case
Time frame: Days 1, 5, 8, 10, and 15
The EASI is a validated tool used to measure the severity and extent of atopic eczema (Eczema Area and Severity Index). The body is divided into 4 sections of total skin area: head including neck (10%); arms including extremities (20%); trunk (30%) and legs including extremities (40%). Each area is scored and the 4 scores are combined into the final EASI. The severity parameters are measured on a scale of 0 to 3 (from none to severe). For each section, the percentage area of skin involved with eczema is estimated and transformed into an extent grade from 0 to 6, from 0% of involved skin area with eczema to 90-100% of involved skin area with eczema. The sum of all four severity parameters is calculated for each section of skin and then multiplied by the weight of the respective section. This value is then multiplied by the extent score for that body area. The EASI value can range from 0-72, a higher score indicates more severe disease.

5 secondary outcomes

Summary of EASI-50 and EASI-75 Responders at Week 2 - Cohort 3
Time frame: Day 14
Percentage of Responders on Investigators Global Assessment in Cohort 3
Time frame: Day 14
Change From Baseline in NRS for Pruritus at Week 2 - Observed Case in Cohort 3
Time frame: Day 1 to day 14
Summary of Patient Global Impression of Change and Logistic Regression of Patient Global Impression of Change in Cohort 3
Time frame: End of treatment (day 15)
Change From Baseline in Body Surface Area at Week 2 - Observed Case in Cohort 3
Time frame: Day 1 to day 14

Results and safety

Results posted to the registry on 5 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 (ZPL-5212372)	8	8
Cohort 1 - Placebo	4	4
Cohort 2 (ZPL-5212372)	8	8
Cohort 2b - Placebo	3	3
Cohort 3 (ZPL-5212372)	20	20
Cohort 3 - Placebo	10	7

Primary outcome: Percent Change From Baseline in EASI Score in Cohort 3

Time frame: Day 1 and Day 14. Mean (Standard Error). Unit: percent change from baseline in EASI

Measure	Cohort 3 (ZPL-5212372) n = 20	Cohort 3 - Placebo n = 10
Observed case	-34.24 (6.288)	-34.29 (10.680)
Multiple imputations	-34.04 (6.445)	-31.03 (11.207)
Last observation carried forward	-34.04 (7.564)	-15.77 (10.712)
Worst case imputation	-33.94 (10.794)	3.66 (15.286)

Cohort 3 (ZPL-5212372) vs Cohort 3 - Placebo: Mean Difference (Net): 0.05 (90% CI -21.24 to 21.34), p = 0.5016, ANCOVA
Cohort 3 (ZPL-5212372) vs Cohort 3 - Placebo: Mean Difference (Net): -3.01 (90% CI -24.39 to 18.36), p = 0.4082, ANCOVA
Cohort 3 (ZPL-5212372) vs Cohort 3 - Placebo: Mean Difference (Net): -18.27 (90% CI -40.65 to 4.11), p = 0.0878, ANCOVA

Population analysed: Full Analysis set

Primary outcome: Percent Change From Baseline in EASI Score Over Time in Cohort 3 - Observed Case

Time frame: Days 1, 5, 8, 10, and 15. Mean (Standard Error). Unit: percent change from baseline in EASI

Measure	Cohort 3 (ZPL-5212372) n = 20	Cohort 3 - Placebo n = 10
Day 5	-16.68 (5.823)	-4.96 (8.247)
Day 8	-27.36 (5.284)	-21.41 (8.358)
Day 10	-32.50 (5.339)	-26.49 (8.445)
Day 15	-34.24 (6.228)	-34.49 (8.445)

Cohort 3 (ZPL-5212372) vs Cohort 3 - Placebo: Mean Difference (Net): -11.72 (90% CI -28.85 to 5.51), p = 0.1284, ANCOVA
Cohort 3 (ZPL-5212372) vs Cohort 3 - Placebo: Mean Difference (Net): -5.95 (90% CI -22.85 to 10.95), p = 0.2765, ANCOVA
Cohort 3 (ZPL-5212372) vs Cohort 3 - Placebo: Mean Difference (Net): -6.01 (90% CI -23.08 to 11.06), p = 0.2765, ANCOVA

Population analysed: Full Analysis set

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days. All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 9 months.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 ZPL-5212372 10% BSA	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Cohort 1 ZPL-5212372 40% BSA	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Cohort 1 Placebo 10% BSA	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Cohort 1 Placebo 40% BSA	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Cohort 2 ZPL-5212372 10% BSA	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Cohort 2 ZPL-5212372 40% BSA	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Cohort 2 Placebo 10% BSA	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Cohort 2 Placebo 40% BSA	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Cohort 3 ZPL-5212372	0 of 20 (0%)	17 of 20 (85%)	0 of 20
Cohort 3 Placebo	0 of 10 (0%)	9 of 10 (90%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Anne Parneix, MD study director

Novartis

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ZPL-5212372 1% w/w Ointment BID in people with Atopic Dermatitis, run by Ziarco Pharma Ltd at 3 sites in United Kingdom.

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 9 inclusion and 11 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 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 5 Apr 2019). 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?

Percent Change From Baseline in EASI Score in Cohort 3 (time frame: Day 1 and Day 14). The study lists 2 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 NCT02795832.

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 5 Apr 2019.