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NCT03403621 · ClinicalTrials.gov registry record · Phase 1
Hypertrophic Scar Prevention by Novel Topical Gel Application
A Phase 1 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03403621: Clinical Trial Phase 1 study, sponsored by Mayo Clinic.
NCT03403621 is a Phase 1 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03403621, a Phase 1 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Researchers are trying to find out more about the side effects of topical (applied to the skin) Pentamidine, to determine if it is safe for use in people. They also want to find out if topical use of Pentamidine can help treat hypertrophic scars. Pentamidine is a medicine that is currently used to treat certain kinds of infection. It is most often given by intravenous (into a vein) or inhalation (through a breathing device). This medication is approved by the U.S. Food and Drug Administration (FDA) for use in these forms. Everyone in this study will receive topical Pentamidine (TP) in a silicone based gel (PCCA Pracasil Plus). Topical treatment of Pentamidine is still experimental and has not been formally tested for safety or effectiveness in a randomized control trial within the United States. The FDA has allowed the use of topical Pentamidine in this research study.
Primary Outcome
Number of participants to experience serious adverse events as defined as death \[due to treatment\] or life threatening adverse experience \[due to treatment\], hospitalization \[due to treatment\], persistent or significant disability or incapacity \[due to treatment\], birth defect/anomalies \[due to treatment\] and tissue necrosis \[due to treatment\].
Interventions
- DRUG Placebo
- DRUG Pentamidine Isethionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-03-05 |
| Est. Completion | 2020-02-26 |
| Phase | Phase 1 |
Why NCT03403621 stopped before completion
NCT03403621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03403621 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03403621 about?
NCT03403621 is a clinical study titled "Hypertrophic Scar Prevention by Novel Topical Gel Application". Researchers are trying to find out more about the side effects of topical (applied to the skin) Pentamidine, to determine if it is safe for use in people. They also want to find out if topical use of Pentamidine can help treat hypertrophic scars. Pentamidine is a medicine that is currently used to ...
What is the current status of trial NCT03403621?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-03-05. Estimated completion is 2020-02-26.
What interventions are being tested in trial NCT03403621?
The interventions under investigation include: Placebo (DRUG), Pentamidine Isethionate (DRUG).
Who is sponsoring clinical trial NCT03403621?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03403621's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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