A Phase 2 interventional study of Tofacitinib ointment 20mg/g and Placebo ointment (Vehicle) in Dermatitis, Atopic, sponsored by Pfizer. Completed at 5 sites in Canada. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-10-15.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 69 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Tofacitinib ointment 20mg/g
Drug: Placebo ointment (Vehicle)
Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks
Placebo ointment (vehicle) twice daily (BID) for 4 weeks
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.
Time frame: Baseline (pre-dose on Day 1) and Week 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.
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
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.
Time frame: 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.
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
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.
Time frame: Baseline (pre-dose on Day 1) and Week 4
Eligibility included male or female participants, 18 to 60 years of age (inclusive), who had a clinical diagnosis of atopic dermatitis for at least 6 months and clinically stable for \>=1 month.
| Milestone | Tofacitinib 20 mg/g BID | Vehicle BID |
|---|---|---|
| Started | 35 | 34 |
| Completed | 34 | 31 |
| Not completed | 1 | 3 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| percent change | Tofacitinib 20 mg/g BID | Vehicle BID |
|---|---|---|
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 | -81.7 ± 6.31 | -29.9 ± 6.46 |
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.
| percentage of participants | Tofacitinib 20 mg/g BID | Vehicle BID |
|---|---|---|
| Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4 | 71.4 | 20.6 |
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.
| percentage of participants | Tofacitinib 20 mg/g BID | Vehicle BID |
|---|---|---|
| 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 | 65.7 | 11.8 |
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.
| percent change | Tofacitinib 20 mg/g BID | Vehicle BID |
|---|---|---|
| Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4 | -72.7 ± 34.1 | -30.2 ± 39.4 |
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.
| units on a scale | Tofacitinib 20 mg/g BID | Vehicle BID |
|---|---|---|
| Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4 | -11.4 ± 5.3 | -4.1 ± 4.5 |
Collected over Baseline up to 28 days after last study drug administration. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tofacitinib 20 mg/g BID | — | 0/35 (0%) | 11/35 (31.4%) |
| Vehicle BID | — | 0/34 (0%) | 19/34 (55.9%) |
| Event | Tofacitinib 20 mg/g BID | Vehicle BID |
|---|---|---|
| Blood creatine phosphokinase increasedInvestigations | 0/35 | 3/34 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 0/35 | 3/34 |
| NasopharyngitisInfections and infestations | 2/35 | 2/34 |
| HeadacheNervous system disorders | 1/35 | 2/34 |
| Conjunctivitis allergicEye disorders | 0/35 | 1/34 |
| Application site pruritusGeneral disorders | 1/35 | 1/34 |
| Seasonal allergyImmune system disorders | 0/35 | 1/34 |
| Upper respiratory tract infectionInfections and infestations | 0/35 | 1/34 |
| Arthropod biteInjury, poisoning and procedural complications | 0/35 | 1/34 |
| SunburnInjury, poisoning and procedural complications | 0/35 | 1/34 |
The full analysis set included all participants who were randomized and received at least 1 dose of study drug.
| Age, Continuous(years) | Tofacitinib 20 mg/g BID | Vehicle BID | Total |
|---|---|---|---|
| Mean | 32.4 ± 9.8 | 30.4 ± 10.4 | 31.4 ± 10.1 |
| Sex: Female, Male(Participants) | Tofacitinib 20 mg/g BID | Vehicle BID | Total |
|---|---|---|---|
| Female | 19 | 18 | 37 |
| Male | 16 | 16 | 32 |
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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