Dermatitis, AtopicPhase 2NCT02001181
Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)
A Phase 2 study testing Tofacitinib ointment 20mg/g in people with Dermatitis, Atopic, run by Pfizer at 5 sites in Canada.
Trial summary
The study is being conducted to evaluate the efficacy, safety and tolerability of 2% tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic dermatitis compared to placebo (vehicle) BID for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Tofacitinib ointment 20mg/g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 5 sitesCanada
- Study dates
- Dec 2013to Sep 2014
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have a clinical diagnosis of atopic dermatitis (also known as atopic eczema) for at least 6 months prior to Day 1 that has been clinically stable for at least 1 month prior to Day 1 and is confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka.
- Have a PGA score of 2 (mild) or 3 (moderate) at Day 1.
- Have atopic dermatitis on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs including palms and soles covering at least 2% of total body surface area (BSA) and up to and including 20% of total BSA at Day 1. At least 2% of the total BSA will need to be on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs (excluding palms and soles).
Who cannot join
- Evidence of certain skin conditions/infections at baseline
- Currently have atopic dermatitis on groin, genitals, palm or soles
- Have certain laboratory abnormalities at baseline
- Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 1Z2
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, Quebec, G1V 4X7
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
About this study
Official title: A Phase 2a, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Pilot Efficacy, Safety, Tolerability, And Pharmacokinetics Of 2% Tofacitinib Ointment In Subjects With Mild To Moderate Atopic Dermatitis
The study is being conducted to evaluate the efficacy, safety and tolerability of 2% tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic dermatitis compared to placebo (vehicle) BID for 4 weeks.
- Conditions
- Dermatitis, Atopic
- Being tested
- Tofacitinib ointment 20mg/g, Placebo ointment (Vehicle)
- Keywords
- Atopic Dermatitis, Atopic Eczema, Eczema, topical treatment, skin diseases, tofacitinib, CP-690, 550, Janus Kinase inhibitor
- Medical subject headings
- Dermatitis, Atopic, Eczema, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib ointment 20mg/gDrug
Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks
Placebo ointment (Vehicle)Drug
Placebo ointment (vehicle) twice daily (BID) for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: Tofacitinib ointment 20mg/g |
| Treatment B | Placebo comparator | Not described Receives: Drug: Placebo ointment (Vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4
The EASI quantifies the severity of a participant's atopic dermatitis based on both lesion severity and the percent of BSA affected. The EASI is a composite scoring by the atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. What is reported is the percent change from baseline in EASI scores.
Measured: Baseline (pre-dose on Day 1) and Week 4
Secondary outcomes (4)
Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4
The PGA score assesses the overall severity of atopic dermatitis. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.
Measured: Week 4
Proportion of Participants With Response of Clear or Almost Clear and Greater Than or Equal to (>=) 2 Grade/Point Improvement From Baseline at Week 4
The PGA score assesses the overall severity of atopic dermatitis. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.
Measured: Baseline (pre-dose on Day 1) and Week 4
Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4
The percent BSA with atopic dermatitis in a body region was determined by the number of handprints of atopic dermatitis skin in that region: head and neck, upper limbs, trunk including axillae, lower limbs including buttocks. In the handprint method, the full palmar hand of the participant (i.e., the participant's fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. What is reported is the percent change from baseline in BSA affected.
Measured: Baseline (pre-dose on Day 1) and Week 4
Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4
The EASI Clinical Signs Severity Sum Score was derived from the EASI. The Clinical Signs Severity Scores on the 4-point scale for dermatitis lesions were summed in each EASI body region. The sum of the Clinical Signs Severity Score in each EASI body region was then totaled across the 4 EASI body regions to provide an EASI Clinical Signs Severity Sum Score, which ranged from 0 to 48, with higher scores representing greater severity of atopic dermatitis.
Measured: Baseline (pre-dose on Day 1) and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionSep 2014
- Study completionSep 2014
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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001181
- Sponsor's protocol ID
- A3921214
- Status last verified
- Sep 2015
- First submitted
- 27 Nov 2013
- Last updated
- 15 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Purohit VS, Ports WC, Wang C, Riley S. Systemic Tofacitinib Concentrations in Adult Patients With Atopic Dermatitis Treated With 2% Tofacitinib Ointment and Application to Pediatric Study Planning. J Clin Pharmacol. 2019 Jun;59(6):811-820. doi: 10.1002/jcph.1360. Epub 2018 Dec 17.
PubMed 30556911
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Pilot Efficacy, Safety, Tolerability, And Pharmacokinetics Of 2% Tofacitinib Ointment In Subjects With Mild To Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02001181
- Acronym / sponsor ID
- A3921214
- Conditions
- Dermatitis, Atopic
- Keywords
- Atopic Dermatitis, Atopic Eczema, Eczema, topical treatment, skin diseases, tofacitinib, CP-690, 550
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Posted 15 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the efficacy, safety and tolerability of 2% tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic dermatitis compared to placebo (vehicle) BID for 4 weeks.
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 |
|---|---|---|
| Treatment group A | Experimental | Drug: Tofacitinib ointment 20mg/g |
| Treatment B | Placebo comparator | Drug: Placebo ointment (Vehicle) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Have a clinical diagnosis of atopic dermatitis (also known as atopic eczema) for at least 6 months prior to Day 1 that has been clinically stable for at least 1 month prior to Day 1 and is confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka.
- Have a PGA score of 2 (mild) or 3 (moderate) at Day 1.
- Have atopic dermatitis on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs including palms and soles covering at least 2% of total body surface area (BSA) and up to and including 20% of total BSA at Day 1. At least 2% of the total BSA will need to be on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs (excluding palms and soles).
Key exclusion criteria (4 listed)
- Evidence of certain skin conditions/infections at baseline
- Currently have atopic dermatitis on groin, genitals, palm or soles
- Have certain laboratory abnormalities at baseline
- Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception
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 |
|---|---|---|
| Tofacitinib ointment 20mg/gTofacitinib ointment 20mg/g twice daily (BID) for 4 weeks | Drug | Treatment group A |
| Placebo ointment (Vehicle)Placebo ointment (vehicle) twice daily (BID) for 4 weeks | Drug | Treatment B |
Primary outcome
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4
Time frame: Baseline (pre-dose on Day 1) and Week 4
The EASI quantifies the severity of a participant's atopic dermatitis based on both lesion severity and the percent of BSA affected. The EASI is a composite scoring by the atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. What is reported is the percent change from baseline in EASI scores.
4 secondary outcomes
Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4
Time frame: Week 4
Proportion of Participants With Response of Clear or Almost Clear and Greater Than or Equal to (>=) 2 Grade/Point Improvement From Baseline at Week 4
Time frame: Baseline (pre-dose on Day 1) and Week 4
Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4
Time frame: Baseline (pre-dose on Day 1) and Week 4
Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4
Time frame: Baseline (pre-dose on Day 1) and Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30556911Purohit VS, Ports WC, Wang C, Riley S. Systemic Tofacitinib Concentrations in Adult Patients With Atopic Dermatitis Treated With 2% Tofacitinib Ointment and Application to Pediatric Study Planning. J Clin Pharmacol. 2019 Jun;59(6):811-820. doi: 10.1002/jcph.1360. Epub 2018 Dec 17.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
5 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 Tofacitinib ointment 20mg/g in people with Dermatitis, Atopic, run by Pfizer at 5 sites in Canada.
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 3 inclusion and 4 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 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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 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 15 Oct 2015). 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 Eczema Area and Severity Index (EASI) Total Score at Week 4 (time frame: Baseline (pre-dose on Day 1) and Week 4). 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 NCT02001181, 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 15 Oct 2015.