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NCT04135560 · ClinicalTrials.gov registry record · Phase 1
A Study To Determine The Safety, Tolerability, Skin Irritation Potential, And PK Following Topical Application Of PF-07038124 In Healthy Participants
A Phase 1 study of Dermatitis, Atopic, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT04135560: Completed Phase 1 study of Dermatitis, Atopic, sponsored by Pfizer.
NCT04135560 is a Phase 1 study of Dermatitis, Atopic that has completed, run by Pfizer. The registered enrollment target is 34 participants, below the 396-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04135560, a Phase 1 study of Dermatitis, Atopic, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs
Conditions Studied
Interventions
- DRUG PF-07038124 and Vehicle
- DRUG PF-07038124 or vehicle
Study Locations (1)
Connecticut
- Pfizer New Haven Clinical Research Unit - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-10-29 |
| Est. Completion | 2020-04-10 |
| Phase | Phase 1 |
What the finished NCT04135560 record still lists
NCT04135560 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 396-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Dermatitis, Atopic appearing as the primary indexed condition, and to 2 interventions - of which PF-07038124 and Vehicle is the first listed.
NCT04135560 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04135560 about?
NCT04135560 is a clinical study titled "A Study To Determine The Safety, Tolerability, Skin Irritation Potential, And PK Following Topical Application Of PF-07038124 In Healthy Participants". 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 w...
What is the current status of trial NCT04135560?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2019-10-29. Estimated completion is 2020-04-10.
What conditions does trial NCT04135560 study?
This clinical trial studies the following conditions: Dermatitis, Atopic.
What interventions are being tested in trial NCT04135560?
The interventions under investigation include: PF-07038124 and Vehicle (DRUG), PF-07038124 or vehicle (DRUG).
Who is sponsoring clinical trial NCT04135560?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04135560 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04135560's enrollment target sits among peer trials
34 29th of 29 higher than 1 of 29 other Dermatitis, Atopic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dermatitis, Atopic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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