Dynamic Changes in Some Facial Muscles After Hyaluronic Acid Filler Injection

August 28, 2021 updated by: marwa eldeeb, Alexandria University

Dynamic Changes in Some Facial Muscles After Superficial Versus Deep Hyaluronic Acid Injection: An Electromyographic Study

assess electrophysiological changes in some facial muscle dynamics following hyaluronic acid filler injection in superficial versus deep level of injection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will be subjected to injection of cross-linked hyaluronic acid fillers on both sides of the face in 3 different regions: temples, cheeks and chins.

Each female will undergo:

  1. Before injection:

    1. Aesthetic facial clinical analysis.
    2. Baseline quantitative surface electromyography.
    3. Baseline digital photography.

  2. Injection:

    Each female will receive the injection in the particular facial region at superficial level to the muscle (subcutaneous) on one side and the same amount at deep level to the muscle (supraperiosteal) on the other side.

  3. One week after injection:

    1. Follow up quantitative surface electromyography.
    2. Follow up digital photography.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Early Phase 1

Contacts and Locations

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

Study Contact

Study Locations

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

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age: 20-60 years.
  2. Sex: females.
  3. Areas eligible for injection: temples, cheeks and chin.

Exclusion Criteria:

  1. Active infection near the site of injection.
  2. Pregnant or lactating women.
  3. Patients suffering from any neuromuscular disorders.
  4. Known allergy/hypersensitivity to hyaluronic acid fillers.
  5. History of botulinum toxin injection in the last 4 months.
  6. History of injection of fillers in the last 2 years.
  7. Patients receiving any muscle relaxants.
  8. Coagulation disorder or anticoagulants therapy.

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: deep injection of hyaluronic acid fillers
Each female will receive filler injection deep to the muscle (supraperiosteal) on one side of the face.
Drug: hyaluronic acid filler injection
quantitative surface electromyography before injection(baseline) and one week after injection
Other Names:
  • quantitative surface electromyography
ACTIVE_COMPARATOR: superficial injection of hyaluronic acid fillers
Each female will receive filler injection at superficial level to the muscle (subcutaneous) on the contralateral side(same dose and same site).
Drug: hyaluronic acid filler injection
quantitative surface electromyography before injection(baseline) and one week after injection
Other Names:
  • quantitative surface electromyography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
electrophysiological changes in some facial muscles
Time Frame: one week
baseline and follow up quantitative surface electromyography
one week

Collaborators and Investigators

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

Sponsor

Alexandria University

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)

October 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

August 28, 2021

First Submitted That Met QC Criteria

August 28, 2021

First Posted (ACTUAL)

September 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 28, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0106665

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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