Botulinum Toxin Injection in Reducing Lip Scar Following... | NCT05559281

Studies
Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair

NCT05559281

Sponsor

Hams Hamed Abdelrahman

Status

Completed

Last Update Posted

Oct 4, 2022Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Cleft Lip

Interventions

Botulinum
Fisher technique

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Oct 1, 2022Actual

Completion Date

Oct 1, 2022Actual

First Submitted Date

Sep 25, 2022

First Submission Date that Met QC Criteria

Sep 28, 2022

First Posted Date

Sep 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2022

Last Update Posted Date

Oct 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria UniversitySponsor-Investigator

Lead Sponsor

Hams Hamed AbdelrahmanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental		Other: Botulinum
Group B	Active Comparator		Procedure: Fisher technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum	Other	injection of Botulinum Toxin injection in lip muscles following cleft lip repair surgically.	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in cleft scar	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	2 weeks, 3 months, 6 months

Secondary Outcomes

Measure	Description	Time Frame
Change in scar width	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	2 weeks, 3 months, 6 months
Change in lip height

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Minutes

Maximum Age

1 Year

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alexandria Faculty of Dentistry		Alexandria			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D002971	Cleft Lip

Ancestor Terms

ID	Term
D008047	Lip Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D009056	Mouth Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided