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Brow PtosisNCT07879456

Enhancing the Durability of Thread-Assisted Brow Suspension Through Upper Blepharoplasty-Assisted Ligament Release

A study testing Upper Blepharoplasty, Barbed Thread Brow Suspension and Lateral Brow-Retaining Ligament Release in people with Brow Ptosis and Dermatochalasis, run by Muhammed Mustafa Demirok at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This prospective clinical study aims to investigate whether combining upper blepharoplasty with limited release of the lateral brow-retaining ligaments improves the long-term effectiveness of barbed thread brow suspension. Lateral eyebrow drooping can contribute to an aged or tired appearance around the eyes. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Brow Ptosis, Dermatochalasis, Periorbital Aging
What is being tested?
Upper Blepharoplasty, Barbed Thread Brow Suspension and Lateral Brow-Retaining Ligament Release
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
27 Oct 2026to 31 Jan 2028
Phase
Interventional
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 20 to 70 years.
  • Patients presenting to the Plastic, Reconstructive and Aesthetic Surgery Department for upper blepharoplasty, brow elevation, or periorbital rejuvenation.
  • Presence of at least one of the following clinical findings: upper eyelid dermatochalasis, lateral brow ptosis, eyebrow descent, or age-related periorbital soft-tissue changes.
  • Having received verbal and written information about the study.
  • Provision of written informed consent.
  • Ability and willingness to comply with the planned surgical procedure and postoperative follow-up visits.
  • Willingness to undergo standardized preoperative and postoperative clinical photography.

Who cannot join

  • History of previous brow-lifting surgery.
  • History of surgery involving the forehead, temporal region, upper eyelid, or periorbital area that may affect study outcomes.
  • Facial paralysis or neuromuscular disorders that may affect eyebrow position.
  • Active local or systemic infection.
  • Uncontrolled systemic disease.
  • Bleeding diathesis or uncontrolled anticoagulant use.
Show all 9Show fewer
  • Known hypersensitivity to the surgical materials or local anesthetic agents used in the study.
  • Pregnancy or breastfeeding.
  • Inability to attend scheduled study follow-up visits regularly.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Muhammed Mustafa Demirok, MD contact

+90 530 899 3773

m.mustafademirok@gmail.com

Turkey (Türkiye)1 site
  • Istanbul Medeniyet University, Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Istanbul, Istanbul, 34720

    Muhammed Mustafa Demirok, MD, +90 530 899 3773, m.mustafademirok@gmail.com

    m.mustafademirok@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: Enhancing the Durability of Thread-Assisted Brow Suspension Through Upper Blepharoplasty-Assisted Retaining Ligament Release: A Hybrid Surgical Approach for Long-Term Brow Elevation

This prospective clinical study aims to investigate whether combining upper blepharoplasty with limited release of the lateral brow-retaining ligaments improves the long-term effectiveness of barbed thread brow suspension.

Lateral eyebrow drooping can contribute to an aged or tired appearance around the eyes. Although thread-based brow lifting can improve eyebrow position, the lifting effect may decrease over time. The researchers aim to determine whether releasing the tissue attachments that restrict eyebrow movement can help maintain the lifting effect.

Read more

The study plans to enroll 90 adults aged 20-70 years, divided into three groups of approximately 30 participants each:

  1. Standard upper blepharoplasty alone.
  2. Standard barbed thread brow suspension alone.
  3. Upper blepharoplasty combined with lateral retaining ligament release and barbed thread brow suspension.

Treatment selection will be based on each participant's anatomical characteristics and clinical indications, without random assignment.

Participants will be evaluated before surgery and at 1 week and 1, 3, 6, and 12 months after surgery. Standardized photographs will be analyzed to measure changes in lateral eyebrow height. Eyebrow symmetry, complications, adverse events, and the need for revision surgery will also be assessed.

The study aims to determine whether the combined surgical approach provides more durable lateral brow elevation without increasing postoperative complications.

Read the detailed description

This is a prospective, single-center, controlled, non-randomized, three-group comparative clinical study designed to evaluate the effectiveness and safety of a hybrid surgical technique for lateral brow elevation.

Background

Lateral brow ptosis and age-related periorbital soft-tissue changes are common aesthetic concerns. Barbed thread suspension provides a minimally invasive method of brow elevation; however, the durability of its lifting effect may be limited by resistance from the lateral brow-retaining ligaments and surrounding soft-tissue attachments.

Limited release of these attachments through an upper blepharoplasty incision may facilitate superior mobilization of the lateral eyebrow and improve the long-term effectiveness of thread suspension.

Study Objective

The primary objective is to compare the durability of lateral brow elevation achieved with upper blepharoplasty-assisted lateral retaining ligament release combined with barbed thread suspension against standard barbed thread suspension alone.

Secondary objectives include assessing eyebrow symmetry, postoperative complications, adverse events, and the need for revision surgery.

Study Population and Design

The study will be conducted at Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, Türkiye.

A total of 90 adults aged 20-70 years with lateral brow ptosis, eyebrow descent, or age-related periorbital soft-tissue changes are planned for enrollment.

Participants will be allocated to three treatment groups according to clinical examination findings, anatomical characteristics, and treatment requirements. No randomization will be performed.

Treatment Groups

Group 1: Standard Upper Blepharoplasty

Participants will undergo conventional upper blepharoplasty without an additional brow-elevating procedure.

Group 2: Standard Barbed Thread Brow Suspension

Participants will undergo lateral brow suspension using CE-marked, double-needle, barbed poly(L-lactide-co-epsilon-caprolactone) (PLACL) threads, without surgical release of the lateral retaining ligaments.

Group 3: Hybrid Brow Elevation

Participants will undergo upper blepharoplasty with limited release of the lateral retaining ligaments and associated soft-tissue attachments, followed by lateral brow suspension using barbed PLACL threads.

Follow-up and Outcome Assessment

All participants will undergo standardized clinical and photographic evaluations at baseline and at postoperative week 1 and months 1, 3, 6, and 12.

The primary outcome is the change in lateral eyebrow height at 12 months compared with baseline, assessed using standardized digital photogrammetry and ImageJ software.

Secondary outcomes include changes in right and left lateral brow height, eyebrow symmetry, early and late postoperative complications, treatment-related adverse events, and the requirement for revision procedures.

Study Hypothesis

The investigators hypothesize that limited lateral retaining ligament release combined with barbed thread suspension will provide more sustained lateral brow elevation than standard thread suspension alone, without a clinically significant increase in complications.

Being tested
Upper Blepharoplasty, Barbed Thread Brow Suspension, Lateral Brow-Retaining Ligament Release
Keywords
Thread Suspension, Upper Blepharoplasty, PLACL Threads, Brow Lift, Hybrid Brow Lift
Medical subject headings
Cutis Laxa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Upper BlepharoplastyProcedure or surgery

    Standard upper blepharoplasty involving excision of excess upper eyelid skin, with management of the orbicularis oculi muscle and orbital fat when clinically indicated. In the hybrid treatment arm, the upper blepharoplasty incision also provides access for limited lateral brow-retaining ligament release.

  • Barbed Thread Brow SuspensionProcedure or surgery

    Lateral brow suspension using CE-marked, double-needle, barbed poly(L-lactide-co-epsilon-caprolactone) (PLACL) threads. The threads are used to elevate and support the lateral eyebrow through fixation to the temporal fascia. The technique is performed either as a standalone brow-lifting procedure or in combination with upper blepharoplasty and lateral retaining ligament release.

  • Lateral Brow-Retaining Ligament ReleaseProcedure or surgery

    Limited surgical release of the lateral brow-retaining ligaments and associated soft-tissue attachments through an upper blepharoplasty incision. The procedure is performed to facilitate superior mobilization of the lateral eyebrow and reduce tissue resistance before barbed thread suspension. This intervention is performed exclusively in the hybrid treatment arm.

Study groups in NCT07879456
Study groupRoleWhat they receive
Standard Upper BlepharoplastyActive comparatorParticipants in this arm will undergo standard upper blepharoplasty without an additional brow-elevating procedure. The surgery will involve excision of excess upper eyelid skin, with management of the orbicularis oculi muscle and orbital fat when clinically indicated. No lateral retaining ligament release or barbed thread brow suspension will be performed. Approximately 30 participants are planned for this arm.
Receives: Procedure: Upper Blepharoplasty
Standard Barbed Thread Brow SuspensionActive comparatorParticipants in this arm will undergo lateral brow elevation using CE-marked, double-needle, barbed poly(L-lactide-co-epsilon-caprolactone) (PLACL) suspension threads. The procedure will be performed without upper blepharoplasty or surgical release of the lateral brow-retaining ligaments. Approximately 30 participants are planned for this arm.
Receives: Procedure: Barbed Thread Brow Suspension
Hybrid Brow ElevationExperimentalParticipants in this arm will undergo upper blepharoplasty combined with limited release of the lateral brow-retaining ligaments and associated soft-tissue attachments through the upper eyelid incision. Lateral brow elevation will subsequently be performed using CE-marked, double-needle, barbed PLACL suspension threads. This hybrid approach aims to improve the durability of lateral brow elevation by reducing tissue resistance before thread suspension. Approximately 30 participants are planned for this arm.
Receives: Procedure: Upper Blepharoplasty; Procedure: Barbed Thread Brow Suspension; Procedure: Lateral Brow-Retaining Ligament Release

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Lateral Brow Height From Baseline to 12 Months

    Change in lateral eyebrow height from the preoperative baseline to postoperative month 12, measured using standardized clinical photographs and digital photogrammetric analysis with ImageJ software. Measurements will use consistent anatomical reference points across visits. Changes will be compared among the three treatment groups to evaluate the durability of lateral brow elevation.

    Measured: Baseline and postoperative month 12

Secondary outcomes (5)
  1. Change in Right and Left Lateral Brow Height

    Changes in right and left lateral eyebrow height relative to baseline, measured separately using standardized clinical photographs and ImageJ digital photogrammetry. Measurements will be compared across treatment groups and postoperative follow-up visits.

    Measured: Baseline; postoperative week 1 and months 1, 3, 6, and 12

  2. Change in Eyebrow Symmetry

    Change in eyebrow symmetry assessed by comparing right and left lateral brow heights on standardized clinical photographs using ImageJ software. Interbrow height differences will be evaluated at baseline and during postoperative follow-up.

    Measured: Baseline; postoperative week 1 and months 1, 3, 6, and 12

  3. Incidence of Early and Late Postoperative Complications

    Number and proportion of participants experiencing postoperative complications during the 12-month follow-up period. Early and late complications will be documented through clinical examination and follow-up assessments and compared across treatment groups.

    Measured: From surgery through postoperative month 12

  4. Incidence of Revision Surgery

    Number and proportion of participants requiring revision surgery related to the initial treatment during the 12-month postoperative follow-up period. Revision requirements will be recorded and compared across the three treatment groups.

    Measured: From surgery through postoperative month 12

  5. Incidence of Treatment-Related Adverse Events

    Number and proportion of participants experiencing treatment-related adverse events during the 12-month follow-up period. Events will be recorded through postoperative clinical assessments, including their nature and relationship to the surgical intervention.

    Measured: From surgery through postoperative month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2026
  2. Study start27 Oct 2026 (estimated)
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
This is a prospective, single-center, non-randomized, parallel-group comparative study involving three treatment arms: (1) standard upper blepharoplasty alone, (2) standard barbed thread brow suspension alone, and (3) upper blepharoplasty combined with lateral retaining ligament release and barbed thread brow suspension. Approximately 30 participants will be enrolled in each arm. Treatment selection will be based on clinical indications, anatomical characteristics, and individual treatment needs rather than random allocation. All participants will undergo standardized postoperative assessments for 12 months.
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07879456
Sponsor's protocol ID
MMD-BROW-01
Status last verified
Oct 2026
First submitted
10 Oct 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because the study involves sensitive clinical information and standardized facial photographs that may pose a risk of participant identification. Data will be maintained confidentially in accordance with the approved study protocol, informed consent, and applicable data protection regulations. Aggregated and de-identified study results will be reported in scientific publications.

Questions about this trial

What is this clinical trial studying?

A study testing Upper Blepharoplasty, Barbed Thread Brow Suspension and Lateral Brow-Retaining Ligament Release in people with Brow Ptosis and Dermatochalasis, run by Muhammed Mustafa Demirok at 1 site in Turkey (Türkiye).

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 7 inclusion and 9 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 16 Oct 2026. 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 Turkey (Türkiye). 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?

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?

Contact Muhammed Mustafa Demirok, MD (+90 530 899 3773, m.mustafademirok@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lateral Brow Height From Baseline to 12 Months (time frame: Baseline and postoperative month 12). 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 16 Oct 2026.

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