WrinklesNCT06871592
Quantified Evaluation of Whole Face 8-points Supra-periosteum High Molecular Weight Hyaluronic Acid Injection in Asian
An observational study of Wrinkles, run by Chang Chang Cheng.
Trial summary
Facial aging is a complex process characterized by skin atrophy, subcutaneous fat loss, and alterations in bone structure. The loss of volume, primarily due to bone resorption and loss of adjacent fat volume from different facial regions, leads to soft tissue flattening. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2025to 27 Feb 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Men and women aged between 20 and 60.
Who may be able to join
- Men and women aged between 20 and 60.
- Subjects who are capable of understanding and comply with the study procedures, instructions, and visit schedule.
- Subjects who voluntarily decide to participate in the entire course of the trial and provide written consent in the Informed Consent Form.
Who cannot join
- Subjects with a history of anaphylaxis, allergy hyaluronic acid products, or any component of devices.
- Subjects with autoimmune diseases/ received immune system and Subjects with diabetes mellitus.
- Subjects with a history of a hypertrophic scar.
- Pregnant or breastfeeding women.
- Subjects with epilepsy or underlying porphyria.
- When there is inactive disease (such as inflammation, infection or tumours) in or near the intended treatment site.
Show all 13Show fewer
- Treatment procedure (e.g., bioresorbable fillers, laser/light therapies, botulinum toxin A injections, face lift, facial peels, excisional facial surgery, dermal photorejuvenation clinically significant oral or maxillofacial surgery, etc.) that may interfere with the treatment area or evaluation within 6 months prior to screening as determined by the Principal Investigator.
- The subject who received soft tissue augmentation as following at the investigational medical device injection site within 6 months prior to screening as determined by the Principal Investigator.
- The subject who received soft tissue augmentation near the injection site with any of the following at any time.
- Subjects with a scar or skin lesion at the investigational medical device injection site that may interfere with the judgment of the treatment effect.
- Subjects who participated in another clinical trial within 60 days prior to screening or plan to participate in another investigation during the course of this study.
- Subjects who plan to receive other wrinkle improvement treatment in the face during this trial.
- Subjects who are otherwise determined by the investigator as ineligible for this study.
About this study
Facial aging is a complex process characterized by skin atrophy, subcutaneous fat loss, and alterations in bone structure. The loss of volume, primarily due to bone resorption and loss of adjacent fat volume from different facial regions, leads to soft tissue flattening. Hyaluronic acid (HA) is a widely used biomaterial in clinical practice, known for its excellent tissue compatibility, low risk, and safety. Previous research and clinical practice have demonstrated that HA for facial lifting can help restore facial fullness, elasticity, and promote a more youthful appearance. Dermatologist previously utilized the supra-periosteum lift technique in high molecular weight hyaluronic acid injection. It was found that the material properties of high molecular weight hyaluronic acid not only made it suitable for filling but also provided lifting support, resulting in improvements in cheek fullness and facial aging. However, there has been no detailed quantitative study on the efficacy of high molecular weight hyaluronic acid for facial lifting.
To further investigate this effect, the investigators plan to conduct a prospective, open-label clinical trial. The investigators will recruit 25 adult and use an 8-point supra-periosteum facial lifting technique to inject high molecular weight hyaluronic acid. Assessments will be conducted preoperatively, postoperatively, and 4 weeks, 12 weeks and 24 weeks postoperatively to analyze the treatment efficacy. The eight injection points will be located at the brow peak, brow tail, pterion, lateral canthus, zygomatic ligament, mid-cheek, nasolabial fold, and mentalis. The investigators will use evaluation forms with four angles and six lengths, as well as the Global Aesthetic Improvement Scale, to quantify the degree of improvement in facial aging. Additionally, The investigators will use a satisfaction survey to understand subjects' perceptions of postoperative lifting effects and overall improvement satisfaction. The investigators hypothesized this study to improve facial aging in Asian patients and provide long-lasting effects.
- Conditions
- Wrinkles
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyebrow Peak angle
The vertices of the Eyebrow Peak angles lie at the static point eyebrow head, measured against a horizontal line parallel to the ground.
Measured: At Week 4, 12, and 24
Eyebrow Tail angle
The vertices of the Eyebrow Tail angles lie at the static point eyebrow head, measured against a horizontal line parallel to the ground.
Measured: At Week 4, 12, and 24
Pupil-Eyebrow Peak angle
The Pupil-Eyebrow Peak angle is then measured between this line and another line connecting nasal to eyebrow peak.
Measured: At Week 4, 12, and 24
Canthus-Oral-Nasal angle
The Canthus-Oral-Nasal angle is measured between a line connecting oral commissure to nasal and a line connecting oral commissure to lateral canthus.
Measured: At Week 4, 12, and 24
Eyebrow-Orbital length
The linear distances from point superior orbital rim to the inferior border of eyebrow.
Measured: At Week 4, 12, and 24
Orbital-Upper Eyelid length
The linear distances from point superior orbital rim to the superior border of palpebral fissure.
Measured: At Week 4, 12, and 24
Vertical Palpebral Fissure length
The size of the palpebral fissure can be determined by measuring the vertical distance between the superior and inferior borders of palpebral fissure when the eyes are at rest.
Measured: At Week 4, 12, and 24
Eyebrow-Iris length
The horizontal distance between the lateral limbus of the iris and the eyebrow peak .
Measured: At Week 4, 12, and 24
Tragus-Oral length
The distances between the bilateral tragi passing through the oral commissure.
Measured: At Week 4, 12, and 24
Lower Facial Contouring length
The distances between the bilateral tragi passing through the mental protuberance.
Measured: At Week 4, 12, and 24
Antiaging Scales for facial rejuvenation
Index 5 is identified as "neutral" or "no significant changes". Total score for the whole face was 100; either lower or higher than 50 suggesting "aging" or "rejuvenation, respectively". °: degree; mm: millimeter.
Measured: At Week 4, 12, and 24
Secondary outcomes (1)
Global Aesthetic Improvement Scale
Subjects with Global Aesthetic Improvement Scale (GAIS) from baseline after injection will be evaluated by a subjects who will judge the severity score.
Score 0 (worse)~4 (Very much improved)
Measured: At Week 4, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start20 Mar 2025 (estimated)
- Primary completion27 Feb 2026 (estimated)
- Study completion27 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Chang Chang Cheng
- Sponsor type
- University, hospital or other
- Collaborators
- Yung Shin Pharm. Ind. Co., Ltd.
- Responsible party
- Sponsor-investigator, Chang Chang Cheng, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871592
- Sponsor's protocol ID
- CMUH114-REC1-003
- Status last verified
- Feb 2025
- First submitted
- 5 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantified Evaluation of Whole Face 8-points Supra-periosteum High Molecular Weight Hyaluronic Acid Injection in Asian
- ClinicalTrials.gov ID
- NCT06871592
- Acronym / sponsor ID
- CMUH114-REC1-003
- Conditions
- Wrinkles
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Chang Chang ChengUniversity, hospital or other
- Collaborators
- Yung Shin Pharm. Ind. Co., Ltd.
- Study start
- 20 Mar 2025 (estimated)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 12 Mar 2025 (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.
Facial aging is a complex process characterized by skin atrophy, subcutaneous fat loss, and alterations in bone structure. The loss of volume, primarily due to bone resorption and loss of adjacent fat volume from different facial regions, leads to soft tissue flattening. Hyaluronic acid (HA) is a widely used biomaterial in clinical practice, known for its excellent tissue compatibility, low risk, and safety. Previous research and clinical practice have demonstrated that HA for facial lifting can help restore facial fullness, elasticity, and promote a more youthful appearance. Dermatologist previously utilized the supra-periosteum lift technique in high molecular weight hyaluronic acid injection. It was found that the material properties of high molecular weight hyaluronic acid not only made it suitable for filling but also provided lifting support, resulting in improvements in cheek fullness and facial aging. However, there has been no detailed quantitative study on the efficacy of high molecular weight hyaluronic acid for facial lifting.
To further investigate this effect, the investigators plan to conduct a prospective, open-label clinical trial. The investigators will recruit 25 adult and use an 8-point supra-periosteum facial lifting technique to inject high molecular weight hyaluronic acid. Assessments will be conducted preoperatively, postoperatively, and 4 weeks, 12 weeks and 24 weeks postoperatively to analyze the treatment efficacy. The eight injection points will be located at the brow peak, brow tail, pterion, lateral canthus, zygomatic ligament, mid-cheek, nasolabial fold, and mentalis. The investigators will use evaluation forms with four angles and six lengths, as well as the Global Aesthetic Improvement Scale, to quantify the degree of improvement in facial aging. Additionally, The investigators will use a satisfaction survey to understand subjects' perceptions of postoperative lifting effects and overall improvement satisfaction. The investigators hypothesized this study to improve facial aging in Asian patients and provide long-lasting effects.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Men and women aged between 20 and 60.
Key inclusion criteria (3 listed)
- Men and women aged between 20 and 60.
- Subjects who are capable of understanding and comply with the study procedures, instructions, and visit schedule.
- Subjects who voluntarily decide to participate in the entire course of the trial and provide written consent in the Informed Consent Form.
Key exclusion criteria (13 listed)
- Subjects with a history of anaphylaxis, allergy hyaluronic acid products, or any component of devices.
- Subjects with autoimmune diseases/ received immune system and Subjects with diabetes mellitus.
- Subjects with a history of a hypertrophic scar.
- Pregnant or breastfeeding women.
- Subjects with epilepsy or underlying porphyria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eyebrow Peak angle
Time frame: At Week 4, 12, and 24
The vertices of the Eyebrow Peak angles lie at the static point eyebrow head, measured against a horizontal line parallel to the ground.
Eyebrow Tail angle
Time frame: At Week 4, 12, and 24
The vertices of the Eyebrow Tail angles lie at the static point eyebrow head, measured against a horizontal line parallel to the ground.
Pupil-Eyebrow Peak angle
Time frame: At Week 4, 12, and 24
The Pupil-Eyebrow Peak angle is then measured between this line and another line connecting nasal to eyebrow peak.
Canthus-Oral-Nasal angle
Time frame: At Week 4, 12, and 24
The Canthus-Oral-Nasal angle is measured between a line connecting oral commissure to nasal and a line connecting oral commissure to lateral canthus.
Eyebrow-Orbital length
Time frame: At Week 4, 12, and 24
The linear distances from point superior orbital rim to the inferior border of eyebrow.
Orbital-Upper Eyelid length
Time frame: At Week 4, 12, and 24
The linear distances from point superior orbital rim to the superior border of palpebral fissure.
Vertical Palpebral Fissure length
Time frame: At Week 4, 12, and 24
The size of the palpebral fissure can be determined by measuring the vertical distance between the superior and inferior borders of palpebral fissure when the eyes are at rest.
Eyebrow-Iris length
Time frame: At Week 4, 12, and 24
The horizontal distance between the lateral limbus of the iris and the eyebrow peak .
Tragus-Oral length
Time frame: At Week 4, 12, and 24
The distances between the bilateral tragi passing through the oral commissure.
Lower Facial Contouring length
Time frame: At Week 4, 12, and 24
The distances between the bilateral tragi passing through the mental protuberance.
Antiaging Scales for facial rejuvenation
Time frame: At Week 4, 12, and 24
Index 5 is identified as "neutral" or "no significant changes". Total score for the whole face was 100; either lower or higher than 50 suggesting "aging" or "rejuvenation, respectively". °: degree; mm: millimeter.
1 secondary outcome
Global Aesthetic Improvement Scale
Time frame: At Week 4, 12, and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
Related trials for Wrinkles
Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Active, not recruiting
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Skin Laxity, Wrinkle
Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrinkles, run by Chang Chang Cheng.
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 13 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: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyebrow Peak angle (time frame: At Week 4, 12, and 24). The study lists 11 primary outcomes in all. 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 13 Mar 2025.