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


Pfizer
NCT ID: NCT03903822
Last Updated: August 5, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 2
  • Gender: All
  • Age: 12 Years - 75 Years
  • Condition: Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Pfizer
  • Location: Not Provided

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

Purpose

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.

Eligibility

Ages Eligible for Study

12 Years to 75 Years

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

Additional Information, Locations & Contacts

Sponsors & Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center

Pfizer

Please refer to this study by its ClinicalTrials.gov identifier: NCT03903822

Location

Contacts

Center for Dermatology and Plastic Surgery/CCT

Scottsdale, Arizona 85260

United States

Center for Dermatology and Plastic Surgery

Scottsdale, Arizona 85260

United States

California Dermatology & Clinical Research Institute

Encinitas, California 92024

United States

New England Associates, LLC

Bridgeport, Connecticut 06606

United States

Dermatology Physicians of Connecticut

Shelton, Connecticut 06484

United States

Jacksonville Center for Clinical Research

Jacksonville, Florida 32216

United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida 32256

United States

Precision Imaging

Jacksonville, Florida 32256

United States

Solutions Throught Advanced Research, Inc

Jacksonville, Florida 32256

United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida 32801

United States

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

Ormond Beach, Florida 32174

United States

Advanced Medical Research PC

Sandy Springs, Georgia 30328

United States

Sneeze, Wheeze & Itch Associates, LLC

Normal, Illinois 61761

United States

Dundee Dermatology

West Dundee, Illinois 60118

United States

DS Research

New Albany, Indiana 47150

United States

DS Research

Louisville, Kentucky 40241

United States

MediSearch Clinical Trials

Saint Joseph, Missouri 64506

United States

Dermatology Consulting Services, PLLC

High Point, North Carolina 27262

United States

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma 74136

United States

Rivergate Dermatology Clinical Research

Goodlettsville, Tennessee 37072

United States

Tanenbaum Dermatology Center

Memphis, Tennessee 38117

United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee 38119

United States

Center for Clinical Studies

Cypress, Texas 77433

United States

Center for Clinical Studies, LTD.LLP

Houston, Texas 77004

United States

Center for Clinical Studies, LTD. LLP

Webster, Texas 77598

United States

Australian Clinical Research Network

Maroubra, New South Wales 2035

Australia

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland 4102

Australia

Emeritus Research

Camberwell, Victoria 3124

Australia

Sinclair Dermatology

East Melbourne, Victoria 3002

Australia

Cabrini Hospital

Malvem, Victoria 3144

Australia

Innovaderm Research Inc

Montreal, Quebec H2K 4L5

Canada

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec J1L 0H8

Canada