A Phase 1 interventional study of PF-07038124 and Vehicle and PF-07038124 or vehicle in Dermatitis Atopic, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-14.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the skin irritation potential of PF-07038124 ointment and vehicle (placebo) in Part A following multiple-doses applied topically to healthy participants. In Part B, the safety, tolerability, pharmacokinetic (PK), and skin irritation potential of PF-07038124 will be evaluated. In Part A, the highest concentration of 0.06% PF-07038124 will be applied to normal skin with a small surface area of 20 cm2 (0.1% body surface area [BSA]), while Part B will evaluate application of PF-07038124 and vehicle (placebo) to a surface area of 2000 cm2 (10% BSA) and 4000 cm2 (20% BSA). These data will provide support for clinical development in participants with mild to moderate AD.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 34 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
Each participant in this cohort will receive both PF-07038124 0.06% and vehicle applied to the skin (1% Body Surface Area)
Drug: PF-07038124 and Vehicle
Drug: PF-07038124 or vehicle
Drug: PF-07038124 or vehicle
Drug: PF-07038124 or vehicle
Drug: PF-07038124 or vehicle
Drug: PF-07038124 or vehicle
Optional cohort of Japanese participants
Drug: PF-07038124 or vehicle
PF-07038124 0.06% and vehicle Ointment BID applied to 1% Body Surface Area (BSA)
PF-07038124 0.01% or vehicle Ointment QD applied to 10% BSA
PF-07038124 0.01% or vehicle Ointment BID applied to 10% BSA
PF-07038124 0.03% or vehicle Ointment BID applied to 10% BSA
PF-07038124 0.06% or vehicle ointment BID applied to 10% BSA
PF-07038124 safe concentration or vehicle ointment BID applied to 20% BSA
PF-07038124 safe concentration or vehicle BID applied to 10% BSA
Part A: Number of Participants with Treatment Emergent Treatment-Related Adverse Evenst (AEs)
Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs
Time frame: through study completion, up to 38 days
Part A: Number of Adverse Events by Severity
Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs
Time frame: through study completion, up to 38 days
Part B: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Assessment of AEs, safety laboratory tests, vital signs (including blood pressure, pulse rate and temperature), cardiac telemetry and 12-lead ECGs. Incidence and severity of local skin irritation.
Time frame: through study completion, up to 41 days
Part B: Number of Adverse Events by Severity
Assessment of AEs, safety laboratory tests, vital signs (including blood pressure, pulse rate and temperature), cardiac telemetry and 12-lead ECGs. Incidence and severity of local skin irritation.
Time frame: through study completion, up to 41 days
Part B: Maximum Observed Plasma Concentration (Cmax)
Time frame: Days 1 and 10
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Days 1 and 10
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Time frame: Days 1 and 10
Plasma Decay Half-Life (t1/2)
Time frame: Days 1 and 10
Average Concentration at Steady State (Cav)
Time frame: Day 10
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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