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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib ointment 20mg/g | Drug | Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (pre-dose on Day 1) and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SKiN Centre for Dermatology | Peterborough | Ontario | K9J 1Z2 | Canada | ||
| The Centre for Dermatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30556911 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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During the screening/washout period, participants' current therapies (topical, systemic, and phototherapy) for atopic dermatitis were discontinued and only non-medicated study emollient, sunscreen topical products, and specific shampoos (for atopic dermatitis on hair-bearing scalp) were permitted.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib 20 mg/g BID | Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks. |
| FG001 | Vehicle BID | Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The full analysis set included all participants who were randomized and received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib 20 mg/g BID | Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks. |
| BG001 | Vehicle BID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The full analysis set (FAS) included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4. | Posted | Least Squares Mean | Standard Error | percent change | Baseline (pre-dose on Day 1) and Week 4 |
|
Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tofacitinib 20 mg/g BID | Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Placebo ointment (Vehicle) | Drug | Placebo ointment (vehicle) twice daily (BID) for 4 weeks |
|
| 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. | 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. | 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. | Baseline (pre-dose on Day 1) and Week 4 |
| Richmond Hill |
| Ontario |
| L4B 1A5 |
| Canada |
| K. Papp Clinical Research | Waterloo | Ontario | N2J 1C4 | Canada |
| Innovaderm Research Inc. | Montreal | Quebec | H2K 4L5 | Canada |
| Centre de Recherche Dermatologique du Quebec metropolitain | Québec | Quebec | G1V 4X7 | Canada |
| Withdrawal by Subject |
|
Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Tofacitinib 20 mg/g BID | Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks. |
| OG001 | Vehicle BID | Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks. |
|
|
|
| Secondary | 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. | The FAS included all participants who were randomized and received at least 1 dose of study drug. Participants who were in FAS and had a baseline PGA score of 2 or 3 were included in the analysis. Participants with missing data at Week 4 were considered non-responders. | Posted | Number | percentage of participants | Week 4 |
|
|
|
| Secondary | 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. | The FAS included all participants who were randomized and received at least 1 dose of study drug. Participants who were in FAS and had a baseline PGA score of 2 or 3 were included in the analysis. Participants with missing data at Week 4 were considered non-responders. | Posted | Number | percentage of participants | Baseline (pre-dose on Day 1) and Week 4 |
|
|
|
| Secondary | 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. | The FAS included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4. | Posted | Mean | Standard Deviation | percent change | Baseline (pre-dose on Day 1) and Week 4 |
|
|
|
| Secondary | 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. | The FAS included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4. | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-dose on Day 1) and Week 4 |
|
|
|
| 0 |
| 35 |
| 11 |
| 35 |
| EG001 | Vehicle BID | Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks. | 0 | 34 | 19 | 34 |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Application site pain | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |