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NCT02227069 · ClinicalTrials.gov registry record · Phase 1
Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers
A Phase 1 study, sponsored by Maruho North America.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02227069: Completed Phase 1 study, sponsored by Maruho North America.
NCT02227069 is a Phase 1 study that has completed, run by Maruho North America. 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
NCT02227069, a Phase 1 study, has completed, sponsored by Maruho North America.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a single center, randomized, controlled, within-subject comparison, multiple dose study to determine the irritation potential of M518101 on normal skin under occlusive patch condition. The study drug will be applied for 21 days under occlusive patch condition. The irritation potential of M518101 will be compared with positive, negative control and M518101 vehicle. The study duration is 21days and there will be at least 23 visits to study center including screening visit.
Primary Outcome
Drug application sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects.
Interventions
- OTHER saline
- DRUG M518101
- DRUG M518101 Vehicle
- OTHER sodium lauryl sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-09 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
What the finished NCT02227069 record still lists
NCT02227069 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 saline is the first listed.
NCT02227069 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02227069 about?
NCT02227069 is a clinical study titled "Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers". This is a single center, randomized, controlled, within-subject comparison, multiple dose study to determine the irritation potential of M518101 on normal skin under occlusive patch condition. The study drug will be applied for 21 days under occlusive patch condition. The irritation potential of M5...
What is the current status of trial NCT02227069?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-09. Estimated completion is 2015-03.
What interventions are being tested in trial NCT02227069?
The interventions under investigation include: saline (OTHER), M518101 (DRUG), M518101 Vehicle (DRUG), sodium lauryl sulfate (OTHER).
Who is sponsoring clinical trial NCT02227069?
This trial is sponsored by Maruho North America, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02227069'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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