CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Botulinum Toxin Type A +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02247193
NCT02247193Phase 2Completed
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Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair

The University of Texas Health Science Center, Houston·interventional·Posted Sep 23, 2014·Updated Nov 3, 2021

In Brief

A Phase 2 clinical trial evaluating Botulinum Toxin Type A and Normal Saline Injection for Cleft Lip and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Objective: To determine if the use of botulinum toxin during primary cleft lip repair improves the cosmetic appearance of the cleft lip scar

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCleft Lip, Scarring, Cleft Palate
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 23, 2014
Enrollment StartDec 1, 2015
Primary CompletionJan 13, 2020
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 11.8 years ago

Interventions

Botulinum Toxin Type Adrug

Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.

Normal Saline Injectiondrug

Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.