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Clinical Trials/NCT05034965
NCT05034965
Unknown
Early Phase 1

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

Alexandria University1 site in 1 country30 target enrollmentStarted: October 2021Last updated:

Overview

Phase
Early Phase 1
Enrollment
30
Locations
1
Primary Endpoint
electrophysiological changes in some facial muscles

Overview

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:

  2. Aesthetic facial clinical analysis.

  3. Baseline quantitative surface electromyography.

  4. Baseline digital photography.

  5. 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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

deep injection of hyaluronic acid fillers

Active Comparator

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

Intervention: hyaluronic acid filler injection (Drug)

superficial injection of hyaluronic acid fillers

Active Comparator

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

Intervention: hyaluronic acid filler injection (Drug)

Outcomes

Primary Outcomes

electrophysiological changes in some facial muscles

Time Frame: one week

baseline and follow up quantitative surface electromyography

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

marwa eldeeb

lecturer of dermatology

Alexandria University

Study Sites (1)

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