AzTrials
AzTrials

Atopic DermatitisPhase 2NCT05375955

A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.

A Phase 2 study testing PF-07038124 ointment 0.01%, PF-07038124 ointment 0.03% and PF-07038124 ointment 0.06% in people with Atopic Dermatitis and Plaque Psoriasis, run by Pfizer at 39 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this clinical trial is to learn about the safety, how well the study medicine works, extent to which side effects can be tolerated, and how the study medicine is changed and eliminated from your body after you apply it on your skin. The study medicine is in ointment form. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Dermatitis, Plaque Psoriasis
What is being tested?
PF-07038124 ointment 0.01%, PF-07038124 ointment 0.03% and PF-07038124 ointment 0.06%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
263 participants
Where
39 sitesin 4 countries
Study dates
26 Sep 2022to 31 Jul 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of Atopic Dermatitis (AD) for at least 3 months
  • Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate)
  • AD covering 5% and up to 40% of Body Surface Area (BSA)
  • A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2
  • Diagnosis of Plaque Psoriasis (PsO) for at least 6 months
  • Physician Global Assessment (PGA) score of 2 (mild), 3 (moderate), or 4 (severe)
  • PsO covering 2% to 20% (inclusive) of BSA

Who cannot join

  • Presence of skin comorbidities that would interfere with study assessment or response to treatment
  • Psychiatric condition including recent or active suicidal ideation or behavior
  • Current or recent history of severe, progressive, or uncontrolled disease
  • A history of systemic, chronic or acute skin infection requiring hospitalization, parenteral antimicrobial therapy, or is judged clinically significant.
  • Recent, significant trauma or major surgery
  • History of cancer or have undergone treatment for any type of cancer, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ with no evidence of recurrence.
Show all 13Show fewer
  • History of angioedema or anaphylaxis to topical products or known sensitivity to any of the components of the investigational products.
  • Use of any prohibited concomitant medication(s)
  • Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
  • Participants with an estimated glomerular filtration rate (eGFR) of <40 mL/min/1.73m2 calculated using the serum creatinine-based Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula for adults and serum creatinine >1.5 x upper limit of normal (ULN) in adolescents (12-18 years old)
  • Participants with total bilirubin ≥2x ULN (≥3 x ULN for Gilbert's disease), aspartate aminotransferase (AST) ≥2.5 x ULN, ALT ≥2.5 x ULN.
  • Clinically relevant abnormal baseline standard 12-lead electrocardiogram (ECG) including, but not limited to QTC corrected using Fridericia's Formula (QTcF) interval >450 msec and QRS > 120 msec
  • A recent history of alcohol or substance abuse

Trial locations and contacts

39 sites in 4 countries.

39 sites in 4 countries

United States23 sites
  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Velocity Clinical Research at The Dermatology Clinic, Baton Rouge

    Baton Rouge, Louisiana, 70808

  • Renaissance Research and Medical Group

    Cape Coral, Florida, 33991

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230

  • Wayne Health

    Dearborn, Michigan, 48124

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida, 32256

  • Northwell Health Clinical Trials Office

    Lake Success, New York, 11042

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Skin Care Physicians of Georgia

    Macon, Georgia, 31217

  • Velocity Clinical Research, Medford

    Medford, Oregon, 97504

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee, 38119

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Memphis, Tennessee, 38119

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10028

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia, 23502

  • Sneeze, Wheeze & Itch Associates, LLC

    Normal, Illinois, 61761

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • ForCare Clinical Research

    Tampa, Florida, 33613

  • Vital Prospects Clinical Research Institute, PC

    Tulsa, Oklahoma, 74136

Other trials in United States

Canada8 sites
  • Dermatology Research Institute

    Calgary, Alberta, T2J 7E1

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1X3

  • DermEdge Research

    Mississauga, Ontario, L4Y 4C5

  • DermEdge Research

    Mississauga, Ontario, L5H 1G9

  • Innovaderm Research Inc.

    Montreal, Quebec, H2X 2V1

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • Centre de Recherche Dermatologique du Quebec metropolitain

    Québec, G1V 4X7

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Japan5 sites
  • Dermatology Shimizu Clinic

    Kobe, Hyōgo, 657-0846

  • Takagi Dermatological Clinic Branch

    Obihiro, Hokkaido, 080-0013

  • Takagi Dermatology

    Obihiro, Hokkaido, 080-0013

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, Osaka, 593-8324

  • Shirasaki dermatology clinic

    Takaoka, Toyama, 933-0871

Other trials in Japan

United Kingdom3 sites
  • Egin Research High Wycombe

    High Wycombe, Buckinghamshire, HP11 2QW

  • Accellacare - North London

    Northwood, London, CITY of, HA6 2RN

  • Southampton General Hospital

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

About this study

Official title: A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE DOSE LEVELS OF PF-07038124 OINTMENT FOR 12 WEEKS IN PARTICIPANTS 12 YEARS AND OLDER AND WITH MILD-TO-MODERATE ATOPIC DERMATITIS OR MILD-TO-SEVERE PLAQUE PSORIASIS

The purpose of this clinical trial is to learn about the safety, how well the study medicine works, extent to which side effects can be tolerated, and how the study medicine is changed and eliminated from your body after you apply it on your skin. The study medicine is in ointment form.

This study is seeking participants who

Read more

If they have Atopic Dermatitis (AD):

  • Have a diagnosis for at least 3 months
  • Have a diagnosis of mild or moderate disease assessed using Investigator's Global Assessment (IGA)
  • Have percent Body Surface Area (%BSA) covering 5% up to 40%
  • A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2 during the screening period

If they have plaque psoriasis (PsO):

  • Have a diagnosis for at least 6 months
  • Have a diagnosis of mild, moderate, or severe disease assessed using Physician's Global Assessment (PGA)
  • Have percent Body Surface Area (%BSA) covering 2% up to 20%

All participants in this study will receive either 0.01% PF-07038124, 0.03% PF-07038124, or a vehicle ointment. In addition, some participants with PsO will receive 0.06% PF- PF-07038124. Participants will not know which dose level they have received. The participants will be randomly assigned to each dose group.

PF-07038124 ointment will be applied topically to affected areas once daily. We will compare the experiences of people receiving the different dose levels of the ointment to those who receive the vehicle ointment. This will help us determine if PF-07038124 ointment is safe and effective.

Participants will take part in this study for approximately 21 weeks. Participants will apply the study medicine once daily for 12 weeks followed by a safety follow-up period of 4-5 weeks from last application of study medicine to last visit.

Being tested
PF-07038124 ointment 0.01%, Vehicle ointment, PF-07038124 ointment 0.03%, PF-07038124 ointment 0.06%
Keywords
Eczema, topical
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07038124 ointment 0.01%Drug

    Atopic Dermatitis and Plaque Psoriasis

  • Vehicle ointmentDrug

    Atopic Dermatitis and Plaque Psoriasis

  • PF-07038124 ointment 0.03%Drug

    Atopic Dermatitis and Plaque Psoriasis

  • PF-07038124 ointment 0.06%Drug

    PF-07038124 ointment 0.06% (Plaque Psoriasis only)

Study groups in NCT05375955
Study groupRoleWhat they receive
Atopic Dermatitis PF-07038124 0.01% ointmentExperimentalAtopic Dermatitis
Receives: Drug: PF-07038124 ointment 0.01%
Atopic Dermatitis Vehicle ointmentPlacebo comparatorAtopic Dermatitis
Receives: Drug: Vehicle ointment
Atopic Dermatitis PF-07038124 0.03% ointmentExperimentalAtopic Dermatitis
Receives: Drug: PF-07038124 ointment 0.03%
Plaque Psoriasis PF-07038124 0.01% ointmentExperimentalPlaque Psoriasis
Receives: Drug: PF-07038124 ointment 0.01%
Plaque Psoriasis PF-07038124 0.03% ointmentExperimentalPlaque Psoriasis
Receives: Drug: PF-07038124 ointment 0.03%
Plaque Psoriasis PF-07038124 0.06% ointmentExperimentalPlaque Psoriasis
Receives: Drug: PF-07038124 ointment 0.06%
Plaque Psoriasis Vehicle ointmentPlacebo comparatorPlaque Psoriasis
Receives: Drug: Vehicle ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only

    IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95 percentage (%)confidence interval was based on Blyth-Still-Casella method.

    Measured: Baseline, Week 12

  2. Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Week 12: Participants With Plaque Psoriasis Only

    The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In this OM, percentages of participants with a PGA score of 0 or 1 and an improvement of >=2 from Baseline in PGA score were reported. 95% confidence interval (CI) was based on Blyth-Still-Casella method.

    Measured: Baseline, Week 12

Secondary outcomes (17)
  1. Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only

    EASI quantified severity of AD based on severity of lesion clinical signs and % of body surface area(BSA)affected.Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I],excoriation[Ex] and lichenification[L]) were scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin)], lower limbs [including buttocks]) on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe.EASI area score was based on % BSA with AD in 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;h= head and neck;u= upper limbs;t= trunk;l= lower limbs.Total EASI score=0.0 to 72.0, higher scores indicate greater severity of AD.EASI 75 response was defined as at least a 75% reduction in EASI relative to Baseline.95% CI was based on Blyth-Still-Casella method.

    Measured: Baseline, Week 1, 2, 4, 6, 8, 10 and 12

  2. Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only

    The PASI quantified the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), 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 PASI score could vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI score =0.1Ah(Eh+Ih+Sh) + 0.2Au(Eu+Iu+Su) + 0.3At(Et+It+St) + 0.4Al(El+Il+Sl) (A= PASI area score,S=scaling)PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. 95% confidence interval was based on Blyth-Still-Casella method.

    Measured: Baseline, Week 1, 2, 4, 6, 8, 10 and 12

  3. Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis Only

    IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95%confidence interval was based on Blyth-Still-Casella method.

    Measured: Baseline, Week 1, 2, 4, 6, 8, and 10

  4. Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis Only

    The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In this OM, percentages of participants with a PGA score of 0 or 1 and an improvement of >=2 from Baseline in PGA score were reported. 95% confidence interval was based on Blyth-Still-Casella method.

    Measured: Baseline, Week 1, 2, 4, 6, 8, and 10

  5. Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only

    IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting. 95% confidence interval was based on Blyth-Still-Casella method.

    Measured: Week 1, 2, 4, 6, 8, 10 and 12

  6. Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only

    The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). 95% confidence interval was based on Blyth-Still-Casella method.

    Measured: Week 1, 2, 4, 6, 8, 10 and 12

  7. Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only

    EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation [I], excoriation [Ex] and lichenification [L]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in 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; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score=0.0 to 72.0, higher scores indicate greater severity of AD. 95% confidence interval was based on Blyth-Still-Casella method.

    Measured: Baseline, Week 1, 2, 4, 6, 8, 10 and 12

  8. Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only

    The PASI quantified the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), 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 PASI score could vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI =0.1Ah(Eh+Ih+Sh) + 0.2Au(Eu+Iu+Su) + 0.3At(Et+It+St) + 0.4Al(El+Il+Sl) (A= PASI area score,S=scaling)PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. 95% confidence interval was based on Blyth-Still-Casella method.

    Measured: Baseline, Week 1, 2, 4, 6, 8, 10 and 12

  9. Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only

    The PP-NRS was a daily participant reported assessment of intensity of pruritus on an 11-point numerical rating scale ranging from 0 ('No Itch) to 10 ('Worst Itch Imaginable'), with a 24-hour recall period. Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 (7 days prior to dosing) and Day -1 (1 day prior to dosing). In this OM, percentages of AD participants with >=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of participants with baseline >=4).

    Measured: Baseline, Week 1, 2, 4, 6, 8, 10 and 12

  10. Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only

    The PP-NRS was a daily participant reported assessment of intensity of pruritus on an 11-point numerical rating scale ranging from 0 ('No Itch) to 10 ('Worst Itch Imaginable'), with a 24-hour recall period. Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 (7 days prior to dosing) and Day -1 (1 day prior to dosing). In this OM, percentages of plaque psoriasis participants (18-75 years old) with >=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of participants with baseline >=4).

    Measured: Week 1, 2, 4, 6, 8, 10 and 12

  11. Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque Psoriasis

    Four 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 hand with fingers in a closed position) 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 percentage (%) BSA for individuals with AD ranged from 5-40 % BSA and for individuals with Psoriasis ranged from 2-20 % BSA. Higher % BSA = greater area affected.

    Measured: Baseline, Week 1, 2, 4, 6, 8, 10 and 12

  12. Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis

    An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered TEAE if the event occurred on or after the first dosing date but before the last dose plus the lag time (35 days).

    Measured: From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)

  13. Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis

    An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other important medical events.

    Measured: From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)

  14. Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis

    Temperature, pulse rate, and blood pressure were assessed in vital sign examination. Body temperature was collected using oral, tympanic, axillary or temporal methods. Blood pressure and pulse rate measurements were assessed with the participant in a supine or seated position using a completely automated device after at least 5 minutes of rest for the participant. Clinically significant changes were determined by the investigator.

    Measured: From start of study treatment (Day 1) up to Week 12

  15. Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis

    A standard 12-lead ECG utilizing limb leads was collected using ECG machine that automatically calculated the heart rate and measured pulse rate, QT, and QTc intervals and QRS complex. Clinically significant findings (including, but not limited to, changes from baseline in QTcF after enrollment) were determined by the investigator or qualified designee.

    Measured: From start of study treatment (Day 1) up to Week 12

  16. Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis

    Laboratory assessments included hematology, clinical chemistry and urinalysis. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

    Measured: From start of study treatment (Day 1) up to Week 12

  17. Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis

    The investigator or designee assessed tolerability at the site of study intervention application, immediately post-application of the study intervention. Skin Tolerability Grading System for non-lesional skin included grade 0 (No evidence of local intolerance), grade 1 (Mild-Minimal erythema and/or edema, slight glazed appearance), grade 2 (Moderate-Definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology), grade 3 (Severe-Erythema, edema glazing with fissures, few vesicles or papules: consider removing topical agent [if still in place], grade 4 (very severe- Strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place].

    Measured: From start of study treatment (Day 1) up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start26 Sep 2022
  3. Primary completion31 Jul 2023
  4. Study completion31 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05375955
Sponsor's protocol ID
C3941005
Status last verified
Sep 2024
First submitted
11 May 2022
Last updated
2 Oct 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-07038124 ointment 0.01%, PF-07038124 ointment 0.03% and PF-07038124 ointment 0.06% in people with Atopic Dermatitis and Plaque Psoriasis, run by Pfizer at 39 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Canada, Japan, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.

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Clinical Trial NCT05375955 | AzTrials