Trials Sponsors Conditions Drugs Pricing

Conditions

Atopic Dermatitis Plaque Psoriasis

Keywords

atopic dermatitis, plaque psoriasis

Outcome Measures

Primary Outcomes (2)

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 for AD Participants
EASI evaluated severity of participants' 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 \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % 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; 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
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 6 for Plaque Psoriasis Participants
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease, where higher scores = greater severity of psoriasis.
Baseline, Week 6

Secondary Outcomes (17)

Percentage of AD Participants Achieving Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) (on a 5-Point Scale) and a Reduction From Baseline of >=2 Points at Week 6
Baseline, Week 6
Percentage of AD Participants Achieving EASI 75 (75% Improvement From Baseline) at Weeks 1, 2, 4, 6 and Follow-up (FUP)/End of Study (EOS)
Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
Percentage of AD Participants Having >=4 Points of Reduction in Weekly Averages of Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 4 and 6
Baseline, Weeks 1, 2, 4 and 6
Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants
Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
Percentage of AD Participants Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS
Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

Study Arms (4)

atopic dermatitis - PF-07038124 ointment

EXPERIMENTAL

Drug: PF-07038124 ointment

atopic dermatitis - vehicle ointment

PLACEBO COMPARATOR

Drug: Vehicle ointment

plaque psoriasis - PF-07038124 ointment

EXPERIMENTAL

Drug: PF-07038124 ointment

plaque psoriasis - vehicle ointment

Interventions

PF-07038124 ointmentDrug

PF-07038124 ointment at 0.01% with QD dosing for 6 weeks

atopic dermatitis - PF-07038124 ointmentplaque psoriasis - PF-07038124 ointment

Vehicle ointmentDrug

Vehicle ointment with QD dosing for 6 weeks

atopic dermatitis - vehicle ointment

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Atopic Dermatitis (AD): Have been diagnosed with AD for at least 3 months; Have an Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate); Have AD covering 5% to 20% (inclusive) of BSA.
Plaque psoriasis: Have been diagnosed with plaque psoriasis (psoriasis vulgaris) for at least 6 months; Have a Physician Global Assessment (PGA) score of 2 (mild), or 3 (moderate); Having plaque psoriasis covering 5% to 15% (inclusive) of BSA.

Sponsors & Collaborators

Pfizer
Industrylead

Study Sites (29)

First OC Dermatology

Fountain Valley, California, 92708, United States

Renaissance Research and Medical Group

Cape Coral, Florida, 33991, United States

Olympian Clinical Research

Clearwater, Florida, 33756, United States

Moonshine Research Center, Inc.

Doral, Florida, 33166, United States

Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States

Center for Clinical Studies

Tampa, Florida, 33613, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Related Publications (1)

Eichenfield LF, Tarabar S, Forman S, Garcia-Bello A, Feng G, Fetterly G, Mahling P, Peeva E, Vincent MS, Chandra DE. Efficacy and Safety of PF-07038124 in Patients With Atopic Dermatitis and Plaque Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2024 Feb 1;160(2):156-163. doi: 10.1001/jamadermatol.2023.4990.
PMID: 38117526DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

104 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 6, 2020

First Posted

December 11, 2020

Study Start

December 21, 2020

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (17)

Study Arms (4)

atopic dermatitis - PF-07038124 ointment

atopic dermatitis - vehicle ointment

plaque psoriasis - PF-07038124 ointment

plaque psoriasis - vehicle ointment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations