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

• ClinicalTrials.gov Identifier: NCT03903822
• Recruitment Status: Completed
• First Posted: April 4, 2019
• Results First Posted: March 29, 2021
• Last Update Posted: March 29, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: PF-06700841; Drug: Vehicle (Placebo)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 292 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: May 13, 2019
• Actual Primary Completion Date: May 7, 2020
• Actual Study Completion Date: May 7, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation [ Time Frame: Baseline, Week 6 ]
   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.

Secondary Outcome Measures :

1. 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 [ Time Frame: Baseline, Week 6 ]
   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.
2. Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation [ Time Frame: Baseline, Week 6 ]
   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.
3. 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 [ Time Frame: Baseline, Weeks 1, 2, 3, 4 and 6 ]
   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.
4. 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 [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71) ]
   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.
5. Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71) ]
   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.
6. 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 [ Time Frame: Baseline, Weeks 1, 2, 3, 4 and 6 ]
   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.
7. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11) ]
   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.
8. Number of Participants With Pre-defined Criteria For Vital Signs [ Time Frame: Baseline up to Week 6 ]
   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.
9. Number of Participants With Laboratory Abnormalities [ Time Frame: Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11) ]
   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.
10. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings [ Time Frame: Baseline up to Week 6 ]
    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.
11. Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit [ Time Frame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71) ]
12. Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit [ Time Frame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71) ]
13. Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit [ Time Frame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71) ]
14. Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit [ Time Frame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71) ]
15. Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit [ Time Frame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71) ]
16. 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 [ Time Frame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71) ]
17. Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit [ Time Frame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71) ]
18. 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 [ Time Frame: Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71) ]
19. Change From Baseline in Lipids Profile Values at Week 6 [ Time Frame: Baseline, Week 6 ]
    Lipid parameters that were assessed: high density lipoprotein (HDL) cholesterol, triglycerides, cholesterol, low density lipoprotein (LDL) cholesterol.
20. Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6 [ Time Frame: Baseline, Week 6 ]
    Mean change in total cholesterol/HDL cholesterol ratio was assessed and reported.
21. Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6 [ Time Frame: Baseline, Weeks 2 and 6 ]
22. Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6 [ Time Frame: Baseline, Weeks 2 and 6 ]
23. Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6 [ Time Frame: Baseline, Weeks 2 and 6 ]
    Blood pressure included supine and sitting systolic and diastolic BP.
24. Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6 [ Time Frame: Baseline, Weeks 2 and 6 ]
25. Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6 [ Time Frame: Baseline, Weeks 2 and 6 ]
26. Number of Participants With Each Severity Grade in Local Tolerability Assessments [ Time Frame: 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) ]
    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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, United States, 35244

United States, Arizona

Center for Dermatology and Plastic Surgery/CCT

Scottsdale, Arizona, United States, 85260

Center for Dermatology and Plastic Surgery

Scottsdale, Arizona, United States, 85260

United States, California

California Dermatology & Clinical Research Institute

Encinitas, California, United States, 92024

First OC Dermatology

Fountain Valley, California, United States, 92708

Beach Allergy and Asthma Specialty Group, A Medical Corporation

Long Beach, California, United States, 90808

Clinical Science Institute

Santa Monica, California, United States, 90404

United States, Connecticut

New England Associates, LLC

Bridgeport, Connecticut, United States, 06606

Dermatology Physicians of Connecticut

Shelton, Connecticut, United States, 06484

United States, District of Columbia

Yolanda C. Holmes, MD

Washington, District of Columbia, United States, 20036

United States, Florida

Olympian Clinical Research

Clearwater, Florida, United States, 33756

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida, United States, 32720

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States, 32216

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States, 32256

Precision Imaging

Jacksonville, Florida, United States, 32256

Solutions Through Advanced Research, Inc

Jacksonville, Florida, United States, 32256

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States, 32801

Leavitt Medical Associates of Florida d/b/a Ameriderm Research

Ormond Beach, Florida, United States, 32174

United States, Georgia

Advanced Medical Research PC

Sandy Springs, Georgia, United States, 30328

United States, Illinois

Sneeze, Wheeze & Itch Associates, LLC

Normal, Illinois, United States, 61761

United States, Indiana

DS Research

New Albany, Indiana, United States, 47150

United States, Kentucky

DS Research

Louisville, Kentucky, United States, 40241

United States, Louisiana

Meridian Clinical Research, LLC

Baton Rouge, Louisiana, United States, 70808

United States, Missouri

MediSearch Clinical Trials

Saint Joseph, Missouri, United States, 64506

United States, North Carolina

Dermatology Consulting Services, PLLC

High Point, North Carolina, United States, 27262

United States, Oklahoma

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States, 73112

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, United States, 74136

United States, South Dakota

Health Concepts

Rapid City, South Dakota, United States, 57702

United States, Tennessee

Tanenbaum Dermatology Center

Memphis, Tennessee, United States, 38117

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States, 38119

United States, Texas

studies in Dermatology, LLC

Cypress, Texas, United States, 77433

Center for Clinical Studies, LTD.LLP

Houston, Texas, United States, 77004

Ventavia Research Group LLC

Hurst, Texas, United States, 76054

Center for Clinical Studies, LTD. LLP

Webster, Texas, United States, 77598

United States, Virginia

Summit Clinical Research, LLC

Franklin, Virginia, United States, 23851

Virginia Dermatology and Skin Cancer Center

Norfolk, Virginia, United States, 23502

Australia, New South Wales

Australian Clinical Research Network

Maroubra, New South Wales, Australia, 2035

Australia, Victoria

Emeritus Research

Camberwell, Victoria, Australia, 3124

Sinclair Dermatology

East Melbourne, Victoria, Australia, 3002

Cabrini Hospital

Malvern, Victoria, Australia, 3144

Bulgaria

Center for Skin and Venereal Diseases EOOD - Sofia

Sofia, Bulgaria, 1404

DCC Alexandrovska

Sofia, Bulgaria, 1431

Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD

Sofia, Bulgaria, 1463

Canada, Manitoba

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada, R3M 3Z4

Canada, Ontario

SKiN Health

Cobourg, Ontario, Canada, K9A 4J9

Canada, Quebec

Innovaderm Research Inc.

Montreal, Quebec, Canada, H2X 2V1

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, Canada, J1L 0H8

Denmark

Gentofte Hospital

Hellerup, Denmark, 2900

Germany

Emovis GmbH

Berlin, Germany, 10629

Rothhaar Studien GmbH

Berlin, Germany, 10783

ISA - Interdisciplinary Study Association GmbH

Berlin, Germany, 10789

Klinikum Bielefeld gem.GmbH

Bielefeld, Germany, 33647

Universitätsklinikum Bonn AöR

Bonn, Germany, 53127

Universitätsklinikum Frankfurt

Frankfurt, Germany, 60590

MENSINGDERMA research GmbH

Hamburg, Germany, 22391

MVZ Alstermed GmbH

Hamburg, Germany, 22391

Dermatologische Gemeinschaftspraxis

Mahlow, Germany, 15831

Klinische Forschung Schwerin GmbH

Schwerin, Germany, 19055

Hungary

Semmelweis Egyetem Altalanos Orvostudomanyi Kar

Budapest, Hungary, 1085

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza

Kecskemet, Hungary, 6000

CRU Hungary Kft.

Miskolc, Hungary, 3529

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Hungary, 6720

Japan

Kitago Dermatology Clinic

Sapporo-shi, Hokkaido, Japan, 003-0833

Nakatsuhifuka Clinic

Kita-ku, Osaka-shi, Osaka, Japan, 531-0072

Parkside Hiroo Ladies Clinic

Minato-ku, Tokyo, Japan, 106-0047

Tanpopo Skin Clinic

Ota Ku, Tokyo, Japan, 143-0023

Shinjuku Minamiguchi Dermatology Skin Clinic

Shinjuku-ku, Tokyo, Japan, 160-0023

Medical Corporation Jitai-kai Tachikawa Dermatology Clinic

Tachikawa, Tokyo, Japan, 190-0023

Latvia

Aesthetic dermatology clinic of Prof. J. Kisis

Riga, Latvia, LV-1003

Health and Aesthetics Ltd

Riga, Latvia, LV-1009

Outpatient Clinic of Ventspils

Ventspils, Latvia, LV3601

Poland

NZOZ Specjalistyczny Ośrodek Dermatologiczny DERMAL s.c.

Bialystok, Poland, 15-453

NASZ LEKARZ Przychodnie Medyczne

Torun, Poland, 87-100

MTZ Clinical Research Sp. z o.o

Warszawa, Poland, 02-106

WroMedica I. Bielicka, A. Strzalkowska s.c.

Wroclaw, Poland, 51-685

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] October 31, 2018

Statistical Analysis Plan  [PDF] May 20, 2020

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03903822
• Other Study ID Numbers: B7931022; 2018-003050-24 ( EudraCT Number )
• First Posted: April 4, 2019
• Results First Posted: March 29, 2021
• Last Update Posted: March 29, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

Mild-to-Moderate Atopic Dermatitis; topical

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases