Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 CREAM APPLIED ONCE OR TWICE DAILY FOR 6 WEEKS IN PARTICIPANTS WITH MILD OR MODERATE ATOPIC DERMATITIS

This study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future clinical development of topical PF-06700841.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Vehicle (Placebo); Drug: PF-06700841

• Study Type: Interventional
• Enrollment (Actual): 292
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Maroubra, New South Wales, Australia, 2035
      • Australian Clinical Research Network
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
    • Malvern, Victoria, Australia, 3144
      • Cabrini Hospital
• Bulgaria
  • Sofia, Bulgaria, 1431
    • DCC Alexandrovska
  • Sofia, Bulgaria, 1404
    • Center for Skin and Venereal Diseases EOOD - Sofia
  • Sofia, Bulgaria, 1463
    • Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research Inc.
  • Ontario
    • Cobourg, Ontario, Canada, K9A 4J9
      • Skin Health
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Diex Recherche Sherbrooke Inc.
• Denmark
  • Hellerup, Denmark, 2900
    • Gentofte Hospital
• Germany
  • Berlin, Germany, 10629
    • emovis GmbH
  • Berlin, Germany, 10783
    • Rothhaar Studien GmbH
  • Berlin, Germany, 10789
    • ISA - Interdisciplinary Study Association GmbH
  • Bielefeld, Germany, 33647
    • Klinikum Bielefeld gem.GmbH
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn AöR
  • Frankfurt, Germany, 60590
    • Universitätsklinikum Frankfurt
  • Hamburg, Germany, 22391
    • Mensingderma Research Gmbh
  • Hamburg, Germany, 22391
    • MVZ Alstermed GmbH
  • Mahlow, Germany, 15831
    • Dermatologische Gemeinschaftspraxis
  • Schwerin, Germany, 19055
    • Klinische Forschung Schwerin GmbH
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem Általános Orvostudományi Kar
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Kecskemet, Hungary, 6000
    • Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
  • Miskolc, Hungary, 3529
    • CRU Hungary Kft.
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
• Japan
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 003-0833
      • Kitago Dermatology Clinic
  • Osaka
    • Kita-ku, Osaka-shi, Osaka, Japan, 531-0072
      • Nakatsuhifuka Clinic
  • Tokyo
    • Minato-ku, Tokyo, Japan, 106-0047
      • Parkside Hiroo Ladies Clinic
    • Ota Ku, Tokyo, Japan, 143-0023
      • Tanpopo Skin Clinic
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Shinjuku Minamiguchi Dermatology Skin Clinic
    • Tachikawa, Tokyo, Japan, 190-0023
      • Medical Corporation Jitai-kai Tachikawa Dermatology Clinic
• Latvia
  • Riga, Latvia, LV-1003
    • Aesthetic dermatology clinic of Prof. J. Kisis
  • Riga, Latvia, LV-1009
    • Health and Aesthetics Ltd
  • Ventspils, Latvia, LV3601
    • Outpatient Clinic Of Ventspils
• Poland
  • Bialystok, Poland, 15-453
    • NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.
  • Torun, Poland, 87-100
    • Nasz Lekarz Przychodnie Medyczne
  • Warszawa, Poland, 02-106
    • MTZ Clinical Research Sp. z o.o
  • Wroclaw, Poland, 51-685
    • WroMedica I. Bielicka, A. Strzalkowska s.c.
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Clinical Research Center of Alabama, LLC
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Center for Dermatology and Plastic Surgery/CCT
    • Scottsdale, Arizona, United States, 85260
      • Center for Dermatology and Plastic Surgery
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Long Beach, California, United States, 90808
      • Beach Allergy and Asthma Specialty Group, A Medical Corporation
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • New England Associates, LLC
    • Shelton, Connecticut, United States, 06484
      • Dermatology Physicians of Connecticut
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • Yolanda C. Holmes, MD
  • Florida
    • Clearwater, Florida, United States, 33756
      • Olympian Clinical Research
    • DeLand, Florida, United States, 32720
      • Accel Research Sites - DeLand Clinical Research Unit
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • Jacksonville, Florida, United States, 32256
      • Precision Imaging
    • Jacksonville, Florida, United States, 32256
      • Solutions Through Advanced Research, Inc
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
    • Ormond Beach, Florida, United States, 32174
      • Leavitt Medical Associates of Florida d/b/a Ameriderm Research
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research Pc
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze & Itch Associates, LLC
  • Indiana
    • New Albany, Indiana, United States, 47150
      • DS Research
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • DS Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Meridian Clinical Research, LLC
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services, PLLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, PC
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Memphis, Tennessee, United States, 38117
      • Tanenbaum Dermatology Center
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
  • Texas
    • Cypress, Texas, United States, 77433
      • Studies in Dermatology, LLC
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, LTD.LLP
    • Hurst, Texas, United States, 76054
      • Ventavia Research Group LLC
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies, LTD. LLP
  • Virginia
    • Franklin, Virginia, United States, 23851
      • Summit Clinical Research, LLC
    • Norfolk, Virginia, United States, 23502
      • Virginia Dermatology and Skin Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of Atopic Dermatitis for at least 3 months
• Investigator's Global Assessment (IGA) Score of 2 or 3
• Eczema Area Severity Index (EASI) score of 3-21
• Body Surface Area (BSA) of 2-20%
• Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion Criteria:

• Other forms of dermatological diseases (other than atopic dermatitis)
• Fitzpatrick skin type score greater than 5
• Clinically significant abnormal ECG, vital signs, and laboratory values
• Infection with HBV, HCV, herpes zoster or tuberculosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-06700841 0.1% cream QD; PF-06700841 0.1% cream applied once daily (QD)	Drug: PF-06700841; PF-06700841 topical cream
Experimental: PF-06700841 0.3% cream QD; PF-06700841 0.3% cream applied once daily (QD)	Drug: PF-06700841; PF-06700841 topical cream
Experimental: PF-06700841 1% cream QD; PF-06700841 1% cream applied once daily (QD)	Drug: PF-06700841; PF-06700841 topical cream
Experimental: PF-06700841 3% cream QD; PF-06700841 3% cream applied once daily (QD)	Drug: PF-06700841; PF-06700841 topical cream
Experimental: PF-06700841 0.3% cream BID; PF-06700841 0.3% cream applied twice daily (BID)	Drug: PF-06700841; PF-06700841 topical cream
Experimental: PF-06700841 1% cream BID; PF-06700841 1% cream applied twice daily (BID)	Drug: PF-06700841; PF-06700841 topical cream
Placebo Comparator: Vehicle cream QD; Vehicle cream applied once daily (QD)	Drug: Vehicle (Placebo); Vehicle topical cream
Placebo Comparator: Vehicle cream BID; Vehicle cream applied twice daily (BID)	Drug: Vehicle (Placebo); Vehicle topical cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation	EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.	Baseline, Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation	IGA assesses severity of participant's AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp.	Baseline, Week 6
Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation	EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.	Baseline, Week 6
Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation	The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.	Baseline, Weeks 1, 2, 3, 4 and 6
Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation	The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.	Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit	4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD.	Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation	EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.	Baseline, Weeks 1, 2, 3, 4 and 6
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 investigational product without regard to possibility of causal relationship. SAE was 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; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.	Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Number of Participants With Pre-defined Criteria For Vital Signs	Pre-defined criteria included: 1) Diastolic blood pressure (DBP), a) sitting DBP: change of >= 20 millimeter of mercury (mmHg) increase, b) sitting DBP: change of >=20mmHg decrease, c) supine DBP: less than (<) 50 mmHg, d) supine DBP: change of >= 20mmHg increase, e) supine DBP: change of >= 20mmHg decrease; 2) Systolic blood pressure (SBP), a) sitting SBP: <90 mmHg, b) sitting SBP: change of >=30mmHg increase, c) sitting SBP: change of >=30mmHg decrease, d) supine SBP: change of >=30mmHg increase, e) supine SBP: change of >=30mmHg decrease and f) Supine SBP: value <90mmHg.	Baseline up to Week 6
Number of Participants With Laboratory Abnormalities	Hemoglobin (HGB),hematocrit,erythrocytes (ery.),HDL cholesterol (chl.)<0.8*lower limit of normal(LLN);reticulocytes (ret.), ret./ery. (%)<0.5*LLN,>1.5*upper limit of normal (ULN);ery. mean corpuscular (EMC) volume,EMC HGB,EMC HGB concentration,potassium,chloride,calcium,bicarbonate<0.9*LLN,>1.1*ULN;platelets<0.5*LLN,>1.75*ULN;leukocytes (leu.),glucose<0.6*LLN,>1.5*ULN;lymphocytes (lym.), lym./leu.(%), neutrophils (neu.), neu./leu. (%), protein,albumin <0.8*LLN,>1.2*ULN;basophils (bas.), bas./leu.(%), eosinophils (eos.), eos./leu., monocytes (mon.), mon./leu.(%), urate >1.2*ULN;bilirubin (total, direct, indirect)>1.5*ULN;aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN;urea nitrogen, creatinine, triglycerides, chl.>1.3*ULN; sodium <0.95*LLN,>1.05*ULN; creatine kinase >2.0*ULN;Urine: pH<4.5,>8;glucose, ketones, protein, HGB, urobilinogen,bilirubin,nitrite,leukocyte esterase>=1;ery., leu.>= 20;hyaline casts>1;bacteria>20.	Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings	Clinically significant ECG criteria included PR interval: value greater than (>) 280 millisecond (msec), percentage change greater than equal to (>=) 25/50 percentage, QRS interval: value >120 msec, percentage change >= 50% and QT interval corrected using the Fridericia's formula (QTCF) value 450 msec and 30<=change<60.	Baseline up to Week 6
Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit		Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit		Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit		Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit		Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit		Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit		Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit		Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit		Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Lipids Profile Values at Week 6	Lipid parameters that were assessed: high density lipoprotein (HDL) cholesterol, triglycerides, cholesterol, low density lipoprotein (LDL) cholesterol.	Baseline, Week 6
Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6	Mean change in total cholesterol/HDL cholesterol ratio was assessed and reported.	Baseline, Week 6
Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6		Baseline, Weeks 2 and 6
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6		Baseline, Weeks 2 and 6
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6	Blood pressure included supine and sitting systolic and diastolic BP.	Baseline, Weeks 2 and 6
Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6		Baseline, Weeks 2 and 6
Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6		Baseline, Weeks 2 and 6
Number of Participants With Each Severity Grade in Local Tolerability Assessments	Local tolerability skin assessments were performed by the investigator and graded based on severity from grade 0 to 4 as: grade 0=none (no evidence of local intolerance); grade 1=mild (minimal erythema and/or oedema, slight glazed appearance); grade 2= moderate (definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology) grade 3=severe (erythema, oedema glazing with fissures, few vesicles or papules consider removing topical agent [if still in place]) and grade 4= very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place]). Higher grades indicated worsening of condition. Only those categories in which at least 1 participant had data were reported.	Day 1 and any day on of Week 1, 2, 4, 6: pre dose (before application of IP) and post dose (after application of IP); Follow up visit (28 days after last dose of study drug = maximum up to Day 71) and Early termination (anytime within week 11)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): May 7, 2020
• Study Completion (Actual): May 7, 2020

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: topical; Mild-to-Moderate Atopic Dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; PF-06700841
• Other Study ID Numbers: B7931022; 2018-003050-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No