NCT05034965

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Oct 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

August 28, 2021

Last Update Submit

August 28, 2021

Conditions

Changes in Facial Muscles Following Filler Injection

Outcome Measures

Primary Outcomes (1)

  • electrophysiological changes in some facial muscles

    baseline and follow up quantitative surface electromyography

    one week

Study Arms (2)

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.

Drug: hyaluronic acid filler injection

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).

Drug: hyaluronic acid filler injection

Interventions

hyaluronic acid filler injectionDRUG

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

Also known as: quantitative surface electromyography
deep injection of hyaluronic acid fillerssuperficial injection of hyaluronic acid fillers

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Alexandria, 21500, Egypt

RECRUITING

Central Study Contacts

Marwa Eldeeb

CONTACT

+201200029774marwa.eldeeb16@alexmed.edu.eg

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of dermatology

Study Record Dates

First Submitted

August 28, 2021

First Posted

September 5, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

September 5, 2021

Record last verified: 2021-08

Locations

EG(1)