Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair

Phase 1

Completed

• Conditions: Cleft Lip; Scarring; Cleft Palate
• Interventions: Drug: Normal Saline Injection; Drug: Botulinum Toxin Type A

• Registration Number: NCT02247193
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-23
• Study Start: 2015-12
• Primary Completion: 2020-01-13
• Study Completion: 2020-01-13
• Results First Submitted: 2021-05-17
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-05
• Last Update Submitted: 2021-10-05
• Results First Posted: 2021-11-03
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• complete unilateral cleft lip with or without cleft palate
• planned for a primary cleft lip repair

Exclusion Criteria

-bilateral cleft lip

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Normal Saline Injection	Injection of normal saline into cleft lip at time of surgical repair.
Botulinum Toxin	Botulinum Toxin Type A	Injection of botulinum toxin into cleft lip at time of surgical repair.

Primary Outcome Measures

Name	Time	Method
Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Blinded Plastic Surgeons	12 months	The Modified Scar Rating Scale (MSRS) assesses surface appearance, scar height, and color mismatch, and total MSRS score ranges from 3 to 12, 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.
Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Crowdsourced Raters	12 months	The Modified Scar Rating Scale (MSRS) assesses surface appearance, scar height, and color mismatch, and total MSRS score ranges from 3 to 12, with a higher score indicating worse scarring. Scars were analyzed by crowdsourced raters via Amazon Mechanical Turk. The crowdsourced raters evaluated frontal and basal photographs of participants. 100 unique responses were elicited per participant. The mean of all crowdsourced ratings for each arm is reported per arm.
Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Blinded Plastic Surgeons	12 months	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.
Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Crowdsourced Raters	12 months	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 crowdsourced raters via Amazon Mechanical Turk. The crowdsourced raters evaluated frontal and basal photographs of participants. 100 unique responses were elicited per participant. The mean of all crowdsourced ratings for each arm is reported per arm.

Trial Locations

Locations (1)

Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States