Dynamic Changes in Some Facial Muscles After Hyaluronic Acid Filler Injection

Alexandria University

Status and phase: Unknown; Early Phase 1

Conditions: Changes in Facial Muscles Following Filler Injection

Treatments: Drug: hyaluronic acid filler injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05034965

0106665

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

deep injection of hyaluronic acid fillers

Active Comparator group

Description:

Each female will receive filler injection deep to the muscle (supraperiosteal) on one side of the face.

Treatment:

Drug: hyaluronic acid filler injection

superficial injection of hyaluronic acid fillers

Active Comparator group

Description:

Each female will receive filler injection at superficial level to the muscle (subcutaneous) on the contralateral side(same dose and same site).

Treatment:

Drug: hyaluronic acid filler injection