Dynamic Changes in Some Facial Muscles After Hyaluronic Acid Filler Injection

Early Phase 1

• Conditions: Changes in Facial Muscles Following Filler Injection
• Interventions: Drug: hyaluronic acid filler injection

• Registration Number: NCT05034965
• Lead Sponsor: Alexandria University

Brief Summary

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

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 Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-28
• Study First Submitted QC: 2021-08-28
• Last Update Submitted: 2021-08-28
• Study First Posted: 2021-09-05
• Last Update Posted: 2021-09-05
• Study Start: 2021-10
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
deep injection of hyaluronic acid fillers	hyaluronic acid filler injection	Each female will receive filler injection deep to the muscle (supraperiosteal) on one side of the face.
superficial injection of hyaluronic acid fillers	hyaluronic acid filler injection	Each female will receive filler injection at superficial level to the muscle (subcutaneous) on the contralateral side(same dose and same site).

Primary Outcome Measures

Name	Time	Method
electrophysiological changes in some facial muscles	one week	baseline and follow up quantitative surface electromyography

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt