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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: Completed Phase 1 study, sponsored by Pyramid Biosciences.
NCT04882631 is a Phase 1 study that has completed, run by Pyramid Biosciences. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Irritation potential based on the Cumulative Irritation Index (CII)
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 |
What the finished NCT04882631 record still lists
NCT04882631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 4 interventions - of which PBI-100 Topical Cream is the first listed.
NCT04882631 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04882631's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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