| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04664153 | Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis | PHASE2 | COMPLETED | 104 | — | — | Dec 21, 2020 | Aug 18, 2021 | Aug 26, 2022 | 29 | United States, Australia +2 |
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.
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.
| Arm | Type | Description |
|---|---|---|
| atopic dermatitis - PF-07038124 ointment | EXPERIMENTAL | - |
| atopic dermatitis - vehicle ointment | PLACEBO_COMPARATOR | - |
| plaque psoriasis - PF-07038124 ointment | EXPERIMENTAL | - |
| plaque psoriasis - vehicle ointment | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-07038124 ointment | DRUG | PF-07038124 ointment at 0.01% with QD dosing for 6 weeks |
| Vehicle ointment | DRUG | Vehicle ointment with QD dosing for 6 weeks |
Inclusion Criteria: * 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...