Changes in Facial Muscles Following Filler InjectionEarly Phase 1NCT05034965
Dynamic Changes in Some Facial Muscles After Hyaluronic Acid Filler Injection
A Early Phase 1 study testing hyaluronic acid filler injection in people with Changes in Facial Muscles Following Filler Injection, run by Alexandria University at 1 site in Egypt.
Trial summary
assess electrophysiological changes in some facial muscle dynamics following hyaluronic acid filler injection in superficial versus deep level of injection. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Changes in Facial Muscles Following Filler Injection
- What is being tested?
- hyaluronic acid filler injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2021to Oct 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-60 years.
- Sex: females.
- Areas eligible for injection: temples, cheeks and chin.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Alexandria, 21500
Marwa Eldeeb, +201200029774, marwa.eldeeb16@alexmed.edu.eg
About this study
Official title: Dynamic Changes in Some Facial Muscles After Superficial Versus Deep Hyaluronic Acid Injection: An Electromyographic Study
assess electrophysiological changes in some facial muscle dynamics following hyaluronic acid filler injection in superficial versus deep level of injection.
Read the 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:
- Before injection:
- Aesthetic facial clinical analysis.
- Baseline quantitative surface electromyography.
- Baseline digital photography.
- 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.
- One week after injection:
- Follow up quantitative surface electromyography.
- Follow up digital photography.
- Being tested
- hyaluronic acid filler injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acid filler injectionDrug
Also called quantitative surface electromyography
quantitative surface electromyography before injection(baseline) and one week after injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: hyaluronic acid filler injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
electrophysiological changes in some facial muscles
baseline and follow up quantitative surface electromyography
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Changes in Facial Muscles Following Filler InjectionStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa eldeeb, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034965
- Sponsor's protocol ID
- 0106665
- Status last verified
- Aug 2021
- First submitted
- 28 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes in Some Facial Muscles After Superficial Versus Deep Hyaluronic Acid Injection: An Electromyographic Study
- ClinicalTrials.gov ID
- NCT05034965
- Acronym / sponsor ID
- 0106665
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Before injection:
- Aesthetic facial clinical analysis.
- Baseline quantitative surface electromyography.
- Baseline digital photography.
- 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.
- One week after injection:
- Follow up quantitative surface electromyography.
- Follow up digital photography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep injection of hyaluronic acid fillers | Active comparator | Drug: hyaluronic acid filler injectionEach female will receive filler injection deep to the muscle (supraperiosteal) on one side of the face. |
| superficial injection of hyaluronic acid fillers | Active comparator | Drug: hyaluronic acid filler injectionEach female will receive filler injection at superficial level to the muscle (subcutaneous) on the contralateral side(same dose and same site). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 20-60 years.
- Sex: females.
- Areas eligible for injection: temples, cheeks and chin.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyaluronic acid filler injectionAlso: quantitative surface electromyographyquantitative surface electromyography before injection(baseline) and one week after injection | Drug | deep injection of hyaluronic acid fillers, superficial injection of hyaluronic acid fillers |
Primary outcome
electrophysiological changes in some facial muscles
Time frame: one week
baseline and follow up quantitative surface electromyography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing hyaluronic acid filler injection in people with Changes in Facial Muscles Following Filler Injection, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Eldeeb (+201200029774, marwa.eldeeb16@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
electrophysiological changes in some facial muscles (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.