Dynamic Changes in Some Facial Muscles After Hyaluronic Acid Filler Injection

NCT ID: NCT05034965

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2022-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Changes in Facial Muscles Following Filler Injection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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deep injection of hyaluronic acid fillers

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

Group Type ACTIVE_COMPARATOR

hyaluronic acid filler injection

Intervention Type DRUG

quantitative surface electromyography before injection(baseline) and one week after injection

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).

Group Type ACTIVE_COMPARATOR

hyaluronic acid filler injection

Intervention Type DRUG

quantitative surface electromyography before injection(baseline) and one week after injection

Interventions

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hyaluronic acid filler injection

quantitative surface electromyography before injection(baseline) and one week after injection

Intervention Type DRUG

Other Intervention Names

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quantitative surface electromyography

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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marwa eldeeb

lecturer of dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Marwa Eldeeb

Role: CONTACT

+201200029774

Facility Contacts

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Marwa Eldeeb

Role: primary

+201200029774

Other Identifiers

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0106665

Identifier Type: -

Identifier Source: org_study_id

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