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NCT04882631 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants
A Phase 1 study, sponsored by Pyramid Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT04882631 is a Phase 1 study that has completed, run by Pyramid Biosciences. The registered enrollment target is 30 participants.
The verdict
NCT04882631, a Phase 1 study, has completed, sponsored by Pyramid Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days.
Interventions
- DRUG PBI-100 Topical Cream
- OTHER Negative Control
- DRUG Positive Control - Sodium laurel sulfate (SLS)
- OTHER PBI-100 Topical Cream, Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-04-12 |
| Est. Completion | 2021-05-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04882631
The ClinicalTrials.gov registry entry for NCT04882631 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pyramid Biosciences, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which PBI-100 Topical Cream is the first listed.
NCT04882631 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04882631 about?
NCT04882631 is a clinical study titled "A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants". This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days.
What is the current status of trial NCT04882631?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-04-12. Estimated completion is 2021-05-03.
What interventions are being tested in trial NCT04882631?
The interventions under investigation include: PBI-100 Topical Cream (DRUG), Negative Control (OTHER), Positive Control - Sodium laurel sulfate (SLS) (DRUG), PBI-100 Topical Cream, Vehicle (OTHER).
Who is sponsoring clinical trial NCT04882631?
This trial is sponsored by Pyramid Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.
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