Subbrow Blepharoplasty;Double Eyelid Surgery； Orbicularis Oculi MuscleNCT04001660
Subbrow Blepharoplasty Combined With Double Eyelid Surgery for Upper Eyelid Rejuvenation in Asian Women
A study testing Subbrow Blepharoplasty Combined with Double Eyelid Surgery in people with Subbrow Blepharoplasty;Double Eyelid Surgery； Orbicularis Oculi Muscle, run by Xijing Hospital at 1 site in China.
Trial summary
Subbrow blepharoplasty combined with double eyelid surgery excising the subbrow skin and the supratarsal upper eyelid skin, lifting and fixing the OOM flap, meanwhile restoring the natural and symmetrical appearance, is a safe, effective, and durable way for treating patients presenting with dermatochalasis. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Subbrow Blepharoplasty;Double Eyelid Surgery； Orbicularis Oculi Muscle
- What is being tested?
- Subbrow Blepharoplasty Combined with Double Eyelid Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 31 Dec 2019
- Phase
- Interventional
- 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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Visual, lacrimal gland and eyelid functions were normal The eyes and eyebrows are aged between 35 and 65 years Informed consent was signed and approved by ethics review
Who cannot join
- Congenital craniofacial deformity, acquired craniofacial injury Scar constitution, pregnancy Mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Subbrow blepharoplasty combined with double eyelid surgery excising the subbrow skin and the supratarsal upper eyelid skin, lifting and fixing the OOM flap, meanwhile restoring the natural and symmetrical appearance, is a safe, effective, and durable way for treating patients presenting with dermatochalasis.
- Being tested
- Subbrow Blepharoplasty Combined with Double Eyelid Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subbrow Blepharoplasty Combined with Double Eyelid SurgeryProcedure or surgery
An upper incision is made along the inferior margin of the eyebrow. A lower incision is determined according to necessary amount of skin excision. Then the skin and subcutaneous tissue were excised. The orbicularis oculi muscle (OOM) was separated and an OOM flap dissection was extended to the width of 15mm. A dissected OOM flap was lifted up and three transverse 3-0 nylon sutures were placed to fix it to the periosteum and then covered by the upper myocutaneous flap of the supraorbital rim. Through eyelid-crease approach the supratarsal upper eyelid skin and orbital fat was excised, adjusted and reshaped double-fold eyelids at the same time.
| Study group | Role | What they receive |
|---|---|---|
| Subbrow Blepharoplasty Combined with Double Eyelid Surgery | Experimental | An upper incision is made along the inferior margin of the eyebrow. A lower incision is determined according to necessary amount of skin excision. Then the skin and subcutaneous tissue were excised. The orbicularis oculi muscle (OOM) was separated and an OOM flap dissection was extended to the width of 15mm. A dissected OOM flap was lifted up and three transverse 3-0 nylon sutures were placed to fix it to the periosteum and then covered by the upper myocutaneous flap of the supraorbital rim. Through eyelid-crease approach the supratarsal upper eyelid skin and orbital fat was excised, adjusted and reshaped double-fold eyelids at the same time. Receives: Procedure: Subbrow Blepharoplasty Combined with Double Eyelid Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (VAS) scores
1, poor; 2, fair; 3, good; 4, very good; and 5, excellent
Measured: postoperative 6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Sep 2017
- Primary completion1 Mar 2018
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subbrow Blepharoplasty;Double Eyelid Surgery； Orbicularis Oculi MuscleStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001660
- Sponsor's protocol ID
- KY20192048-F-2
- Status last verified
- Jan 2019
- First submitted
- 24 Jun 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subbrow Blepharoplasty Combined With Double Eyelid Surgery for Upper Eyelid Rejuvenation in Asian Women
- ClinicalTrials.gov ID
- NCT04001660
- Acronym / sponsor ID
- KY20192048-F-2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 28 Jun 2019 (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.
Subbrow blepharoplasty combined with double eyelid surgery excising the subbrow skin and the supratarsal upper eyelid skin, lifting and fixing the OOM flap, meanwhile restoring the natural and symmetrical appearance, is a safe, effective, and durable way for treating patients presenting with dermatochalasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subbrow Blepharoplasty Combined with Double Eyelid Surgery | Experimental | Procedure: Subbrow Blepharoplasty Combined with Double Eyelid SurgeryAn upper incision is made along the inferior margin of the eyebrow. A lower incision is determined according to necessary amount of skin excision. Then the skin and subcutaneous tissue were excised. The orbicularis oculi muscle (OOM) was separated and an OOM flap dissection was extended to the width of 15mm. A dissected OOM flap was lifted up and three transverse 3-0 nylon sutures were placed to fix it to the periosteum and then covered by the upper myocutaneous flap of the supraorbital rim. Through eyelid-crease approach the supratarsal upper eyelid skin and orbital fat was excised, adjusted and reshaped double-fold eyelids at the same time. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Visual, lacrimal gland and eyelid functions were normal The eyes and eyebrows are aged between 35 and 65 years Informed consent was signed and approved by ethics review
Key exclusion criteria (1 listed)
- Congenital craniofacial deformity, acquired craniofacial injury Scar constitution, pregnancy Mental illness
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 |
|---|---|---|
| Subbrow Blepharoplasty Combined with Double Eyelid SurgeryAn upper incision is made along the inferior margin of the eyebrow. A lower incision is determined according to necessary amount of skin excision. Then the skin and subcutaneous tissue were excised. The orbicularis oculi muscle (OOM) was separated and an OOM flap dissection was extended to the width of 15mm. A dissected OOM flap was lifted up and three transverse 3-0 nylon sutures were placed to fix it to the periosteum and then covered by the upper myocutaneous flap of the supraorbital rim. Through eyelid-crease approach the supratarsal upper eyelid skin and orbital fat was excised, adjusted and reshaped double-fold eyelids at the same time. | Procedure or surgery | Subbrow Blepharoplasty Combined with Double Eyelid Surgery |
Primary outcome
visual analog scale (VAS) scores
Time frame: postoperative 6month
1, poor; 2, fair; 3, good; 4, very good; and 5, excellent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subbrow Blepharoplasty Combined with Double Eyelid Surgery in people with Subbrow Blepharoplasty;Double Eyelid Surgery； Orbicularis Oculi Muscle, run by Xijing Hospital at 1 site in China.
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 1 inclusion and 1 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 28 Jun 2019. 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 China. 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.
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?
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?
visual analog scale (VAS) scores (time frame: postoperative 6month). 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 28 Jun 2019.