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Completed

NCT Number: NCT07137234

Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy.

the aim of the study will be directed to evaluate clinically the effect of botulinum toxin type A injection on reducing the scar following cleft lip surgical repair.

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Key information

Conditions

Unilateral Cleft Lip Cicatrix Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fibrosis Lip Diseases Mouth Abnormalities Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

10 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with mild to severe unilateral cleft lip requiring repair
  • free from any systemic disease
  • with or without cleft palate
  • fit for general anesthesia exclusion criteria :
  • patients with syndromic type of cleft lip
  • patients with systemic disease

Treatment and study plan

Modified Millard rotation advancement flap technique

Procedure

the cleft is repaired by surgical intervention

botulinum toxin injection (BTX A) before surgical intervention

Drug

the patient will receive Botulinum toxin type A followed by surgical closure of cleft lip

Primary outcomes

  1. Scar width

    Time frame: 3 and 6 months follow up

    Scar width will be measured by independent examiners at two at two certain points using caliper:

    point 1 (Bottom) :above the white roll. point 2 (Top): below the nasal sill.

Secondary outcomes

  1. Vancouver scar scale

    Time frame: 3 and 6 months

    it evaluates four factors: pigmentation, pliability, height, and vascularity. it is used to asses treatment.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Efficacy of Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy: A Randomized Controlled Clinical Trial.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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