Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair

Evaluation of Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair (Randomized Controlled Clinical Trial)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05559281

Enrollment

Registered

2022-09-29

Start date

2021-07-01

Completion date

2022-10-01

Last updated

2022-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip

Brief summary

A cleft lip is a congenital defect resulting from failing to merge developmental processes in the Orofacial region. One of the most common complications surgeons fear after cleft lip repair is a hypertrophic scar. A cleft scar negatively affects a patient's appearance, psychology, and function. Several techniques have been proposed to improve lip scars such as steroid therapy, laser therapy, and silica gel. Despite such efforts, the results were still unsatisfactory. Botulinum Toxin injections may provide a more reliable method

Interventions

OTHERBotulinum

injection of Botulinum Toxin injection in lip muscles following cleft lip repair surgically.

PROCEDUREFisher technique

The cleft lip will be treated surgically using the Fisher technique only.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Minutes to 1 Years

Healthy volunteers

Inclusion criteria

* With mild to severe cleft lip deformity requiring repair. * Neonates up to 1 year of age. * Patients with or without cleft palate. * Systemically healthy patients. * Patients follow postoperative instructions provided by their legal guardians.

Exclusion criteria

* Patients with a syndromic type of cleft lip. * Patients suffering from relevant systemic and metabolic diseases. * Patients suffering from immunosuppressive diseases. * Patients suffering from neuromuscular disorders like Myasthenia Gravis. * Patients with special needs.

Design outcomes

Primary

Measure	Time frame	Description
Change in cleft scar	2 weeks, 3 months, 6 months	Vancouver Scar Scale: This scale focuses on four parameters: scar height and thickness, pliability, vascularity, and pigmentation to generate a score ranging from 0 to 13 point

Secondary

Measure	Time frame	Description
Change in scar width	2 weeks, 3 months, 6 months	The scar width is to be measured at two certain points using digital caliper, one point is 1 mm above white line and the second point is 1 mm below nasal
Change in lip height	2 weeks, 3 months, 6 months	The lip height measurement will be done using digital caliper at cleft and non-cleft side.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026