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NCT02247193 · ClinicalTrials.gov registry record · Phase 1
Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair
A Phase 1 study of Cleft Palate and Scarring, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT02247193: Completed Phase 1 study of Cleft Palate and Scarring, sponsored by The University of Texas Health Science Center, Houston.
NCT02247193 is a Phase 1 study of Cleft Palate and Scarring that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 30 participants, below the 671-participant average among 9 other Cleft Palate trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02247193, a Phase 1 study of Cleft Palate and Scarring, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Objective: To determine if the use of botulinum toxin during primary cleft lip repair improves the cosmetic appearance of the cleft lip scar
Primary Outcome
The Manchester Scar Scale (MSS) assesses color match to surrounding skin, skin texture, contour, and distortion, and total MSS score ranges from 4 to 14, with a higher score indicating worse scarring. Scars were analyzed by three blinded plastic surgeons, who evaluated frontal and basal photographs of participants. The median of the three surgeon scores per participant was first calculated, and then the median all medians was calculated per arm.
Conditions Studied
Interventions
- DRUG Botulinum Toxin Type A
- DRUG Normal Saline Injection
Study Locations (1)
Texas
- Memorial Hermann Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-12 |
| Est. Completion | 2020-01-13 |
| Phase | Phase 1 |
What the finished NCT02247193 record still lists
NCT02247193 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 671-participant average among 9 other Cleft Palate trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Cleft Palate appearing as the primary indexed condition, and to 2 interventions - of which Botulinum Toxin Type A is the first listed.
NCT02247193 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02247193 about?
NCT02247193 is a clinical study titled "Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair". Objective: To determine if the use of botulinum toxin during primary cleft lip repair improves the cosmetic appearance of the cleft lip scar
What is the current status of trial NCT02247193?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2015-12. Estimated completion is 2020-01-13.
What conditions does trial NCT02247193 study?
This clinical trial studies the following conditions: Cleft Palate, Scarring, Cleft Lip.
What interventions are being tested in trial NCT02247193?
The interventions under investigation include: Botulinum Toxin Type A (DRUG), Normal Saline Injection (DRUG).
Who is sponsoring clinical trial NCT02247193?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02247193 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02247193's enrollment target sits among peer trials
30 10th of 9 the lowest of 9 other Cleft Palate trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cleft Palate 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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