Evaluation of the Effect of Botulinum Toxin Type-A Injection Prior to Surgical Correction of Complete Unilateral Cleft Lip Repair by Modified Millard Cheiloplasty

February 8, 2017 updated by: Mostafa Khairy

Evaluation of the Effect of Botulinum Toxin Type-A Injection Prior to Surgical Correction of Complete Unilateral Cleftlip Repair by Modified Millard Cheiloplasty

Evaluation of the effect of botulinum toxin type-A injection prior to surgical correction of complete unilateral cleftlip repair by modified millard cheiloplasty

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 72427
        • Recruiting
        • Cairo University
        • Contact:
          • Rehab Tariq Elsharkawy, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 6 months (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children up to 6 months

Description

Inclusion Criteria:

  • Primary cleft lip

Exclusion Criteria:

  • Cleft palate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Scar Length
Drug: Botulinum toxin type A
Botulinum toxin type-A injection
Vancouver scar scale
Drug: Botulinum toxin type A
Botulinum toxin type-A injection
Scar width
Drug: Botulinum toxin type A
Botulinum toxin type-A injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scar Length
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mostafa Khairy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 15, 2017

Primary Completion (ANTICIPATED)

October 15, 2017

Study Completion (ANTICIPATED)

November 15, 2017

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (ESTIMATE)

February 9, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBC-CU-2017-02-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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