Evaluation of Deep Plan Intervention in the Submental Region for Double Chin ManagementNCT07391176
Evaluation of the Effectiveness of Deep Intervention in the Submental Region in Context of Managing of Double Chin (Clinical Study)
A study testing Evaluation of platysma muscle partial resection with midline plication for double chin correction in people with Evaluation of Deep Plan Intervention in the Submental Region for Double Chin Management, run by Latakia University at 1 site in Syria.
Trial summary
what problem is this study investigating some people suffer from what is called a double chin or the accumulation of fat and sagging skin under the chin which may affect the profile and cause dissatisfaction what is the main objective of this study this study aims to evaluating the efficacy and safety of a targeted… Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Evaluation of Deep Plan Intervention in the Submental Region for Double Chin Management
- What is being tested?
- Evaluation of platysma muscle partial resection with midline plication for double chin correction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSyria
- Study dates
- 9 Jan 2024to 19 Jan 2026
- 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 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 45 years and older.
- Systemic health : systemically healthy individuals (without significant systemic diseases), in good general health (ASA SCORE I OR II).
- Anatomical classification: participants classified as Type D according to Dedo Cervicomental angle classification (characterized by increased submental fat with platysma laxity and loss of angle definition due to both skin and fat).
- weight stability : proposed addition. stable weight loss.
Who cannot join
- Age: under 45 years
- Systemic diseases: presence of uncontrolled or relevant systemic diseases affecting wound healing or outcomes
- active autoimmune diseases
- uncontrolled diabetes mellitus.
- bleeding or coagulation disorders
- advanced chronic liver or kidney disease.
Show all 16Show fewer
- anatomical classification: any Dedo classification other than type D (Type A,B,C).
- Relevant medical history :proposed addition.
- history of previous surgical or cosmetic interventions in the neck/chin area
- active skin diseases or infections in the treatment area. .known history of hypertrophic or keloid scarring.
- Medication and supplements: proposed addition.
- use of anticoagulant medications (warfarin, clopidogrel)
- use supplements or medications affecting bleeding (high-dose aspirin, ibuprofen, fish oil, garlic ,ginkgo biloba) within a specified period before the procedure.
- Lifestyle factors: proposed addition.
- heavy smoking ( negatively affects wound healing ).
- significant alcohol consumption.
Trial locations and contacts
1 site in 1 country.
About this study
what problem is this study investigating some people suffer from what is called a double chin or the accumulation of fat and sagging skin under the chin which may affect the profile and cause dissatisfaction what is the main objective of this study this study aims to evaluating the efficacy and safety of a targeted submentoplasty surgical procedure. this procedure involves
- making a horizontal submental incision
- performing midline platysma resection and suturing with lateral platysma plication along defined vectors
- Excision of redundant skin potentially extending to the periauricular area as needed.
Read more
Who can participate in this study inclusion criteria
- Be 45 years of age or older
- present with moderate to severe submental fullness and skin laxity classified as Dedo type D(prominent platysma bands with significant skin redundancy)
- Be in good general systemic health with no contraindication to elective surgery or anesthesia.
- Have a stable weight (no significant gain or loss in the past 6 months). .Express dissatisfaction with their submental contour and desire surgical correction.
- Be anon-smoker or agree to cease smoking for a minimum of 4 weeks before and after the procedure.
Exclusion criteria
- previous history of any surgical procedure in the submental area,neck,or lower face(face lift ,neck lift, submentoplasty ,or liposuction).
- previous history of any injectable treatment (deoxycholic acid ,filler, collagen stimulators ) in the submental area within the past 12 months.
- presence of an active skin infection or inflammatory condition in the treatment area.
- Known bleeding disorder or use of anticoagulant medication that cannot be safely paused for the procedure.
- unrealistic expectations regarding surgical outcomes.
- Significant medical comorbidities that increase surgical risk(uncontrolled diabetes ,severe cardiovascular disease).
Final eligibility will be determined during a comprehensive screening consultation with the principal surgeon, which will include a physical examination and detailed medical history review.
What does the study involved if you participate? This is a prospective ,singal-arm clinical study designed to evaluate the effectiveness and safety of a targeted submentoplasty procedure. A total of 12 eligible female participants will be enrolled.
procedure details : if you qualify and consent to participate ,you will undergo the following surgical intervention:
- The procedure will be performed under local anesthesia or general anesthesia.
- It involves : making a horizontal submental incision ,performing midline platysma resection and suturing , lateral platysma plication along defined vectors , and excision of redundant skin with possible periauricular extension.
- The surgery will be performed in latakia university hospital.
Study time line and Assessments:
Your participation will involve the following schedule:
- Pre-Treatment visit: A screening visit to confirm eligibility , take detailed medical history , and perform standardized photographic documentation(front and side views) of your face and neck.
- The treatment visit :The day of the scheduled surgical procedure.
- Follow-up visit : You will be required to attend post-operative follow-up appointments at two key time points to monitor results and safety :
- 1 month after the procedure.
- 3 month after the procedure.
Assessments at Each follow-up: Each follow-up visit will include:
- Photographic documentation : Repeated standardized photographs (identical views to the pre-treatment photos) to allow for objective comparison and assessment of improvement .
- Clinical Evaluation : An assessment by the surgeon for healing , aesthetic outcome , and any potential complication .
- Patient-repoted outcomes :you will be asked to complete a brief questionnaire about your satisfaction with the results , improvement in your appearance , and any symptoms .
- Your commitment: participation requires your commitment to attend the pre-treatment visit , undergo the surgery , and attend both follow-up visits at 1 month 3 months post-operative care instructions provided by the surgical team.
. Data collection: The primary method for evaluating effectiveness will be the comparative analysis of the standardized photographs taken before the surgery and at the 1-month and 3-moths follow-up visits. clinical notes and your questionnaire responses will provide supporting data on safety and satisfaction.
. What are the expected benefits of participation? you may achieve an improved appearance and definition of the chin area through surgical procedure. this can enhance facial harmony and potentially boost your self-confidence.
What are the potential risks of participation? potential risks associated with this surgical procedure include, but are not limited to: bleeding, infection, noticeable scarring, adverse reactions to anesthesia, temporary or permanent nerve damage, irregularity in the jawline and neck contour changes in ear position
- Being tested
- Evaluation of platysma muscle partial resection with midline plication for double chin correction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of platysma muscle partial resection with midline plication for double chin correctionProcedure or surgery
The surgical procedure will be performed in two consecutive stages
Phase one - midline correction:
- submental liposuction : fat is aspirated from the submental region via a small puncture using a cannula.
- Access expansion: the puncture entry is extended to form a small horizontal submental incision.
- Dissection and exposure: the area is dissected through this incision using blunt dissection techniques to expose the midline platysma muscle.
- Muscle excision: an elliptical segment of the platysma muscle is excised at the midline level.
- Closure: the resulting muscular defect is closed with primary suturing.
Phase two-lateral correction :
- lateral access :the lateral aspect of the platysma muscle and the superficial musculoaponeurotic system is accessed via concealed peri-auricular incision
- Plication and tightening: the platysma and smas are plicate and tighten along natural tension lines to lift the jawline and neck contours.
- finally redundant skin excision and suturing.
| Study group | Role | What they receive |
|---|---|---|
| Surgical submental correction for Double chin | Experimental | Not described Receives: Procedure: Evaluation of platysma muscle partial resection with midline plication for double chin correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervicomental angle (in degrees) as measured using AutoCAD software.
The chin point( the lowest point on the chin in lateral view) and a point on the sternum(the highest prominent point of the sternum at the head) will be identified.
Then, the point of the chin-neck junction(the lowest point of the curvature under the chin) will be determined. Subsequently, a line will be drawn connecting the chin point to the chin-neck junction point (the first side),and another line connecting the chin-neck junction point to sternum point(the second side) using the line tool in Adobe Photoshop. finally, the angel formed between these two sides will be measured using AutoCAD program.
Measured: Measured at three time point : before treatment(baseline),1 month after treatment, and 3 moths after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start9 Jan 2024
- Primary completion10 Jan 2026
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Deep Plan Intervention in the Submental Region for Double Chin ManagementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391176
- Sponsor's protocol ID
- Tishreen-U O,M Fascial surgery
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Deep Intervention in the Submental Region in Context of Managing of Double Chin (Clinical Study)
- ClinicalTrials.gov ID
- NCT07391176
- Acronym / sponsor ID
- Tishreen-U O,M Fascial surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 5 Feb 2026 (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.
what problem is this study investigating some people suffer from what is called a double chin or the accumulation of fat and sagging skin under the chin which may affect the profile and cause dissatisfaction what is the main objective of this study this study aims to evaluating the efficacy and safety of a targeted submentoplasty surgical procedure. this procedure involves
- making a horizontal submental incision
- performing midline platysma resection and suturing with lateral platysma plication along defined vectors
- Excision of redundant skin potentially extending to the periauricular area as needed.
Who can participate in this study inclusion criteria
- Be 45 years of age or older
- present with moderate to severe submental fullness and skin laxity classified as Dedo type D(prominent platysma bands with significant skin redundancy)
- Be in good general systemic health with no contraindication to elective surgery or anesthesia.
- Have a stable weight (no significant gain or loss in the past 6 months). .Express dissatisfaction with their submental contour and desire surgical correction.
- Be anon-smoker or agree to cease smoking for a minimum of 4 weeks before and after the procedure.
Exclusion criteria
- previous history of any surgical procedure in the submental area,neck,or lower face(face lift ,neck lift, submentoplasty ,or liposuction).
- previous history of any injectable treatment (deoxycholic acid ,filler, collagen stimulators ) in the submental area within the past 12 months.
- presence of an active skin infection or inflammatory condition in the treatment area.
- Known bleeding disorder or use of anticoagulant medication that cannot be safely paused for the procedure.
- unrealistic expectations regarding surgical outcomes.
- Significant medical comorbidities that increase surgical risk(uncontrolled diabetes ,severe cardiovascular disease).
Final eligibility will be determined during a comprehensive screening consultation with the principal surgeon, which will include a physical examination and detailed medical history review.
What does the study involved if you participate? This is a prospective ,singal-arm clinical study designed to evaluate the effectiveness and safety of a targeted submentoplasty procedure. A total of 12 eligible female participants will be enrolled.
procedure details : if you qualify and consent to participate ,you will undergo the following surgical intervention:
- The procedure will be performed under local anesthesia or general anesthesia.
- It involves : making a horizontal submental incision ,performing midline platysma resection and suturing , lateral platysma plication along defined vectors , and excision of redundant skin with possible periauricular extension.
- The surgery will be performed in latakia university hospital.
Study time line and Assessments:
Your participation will involve the following schedule:
- Pre-Treatment visit: A screening visit to confirm eligibility , take detailed medical history , and perform standardized photographic documentation(front and side views) of your face and neck.
- The treatment visit :The day of the scheduled surgical procedure.
- Follow-up visit : You will be required to attend post-operative follow-up appointments at two key time points to monitor results and safety :
- 1 month after the procedure.
- 3 month after the procedure.
Assessments at Each follow-up: Each follow-up visit will include:
- Photographic documentation : Repeated standardized photographs (identical views to the pre-treatment photos) to allow for objective comparison and assessment of improvement .
- Clinical Evaluation : An assessment by the surgeon for healing , aesthetic outcome , and any potential complication .
- Patient-repoted outcomes :you will be asked to complete a brief questionnaire about your satisfaction with the results , improvement in your appearance , and any symptoms .
- Your commitment: participation requires your commitment to attend the pre-treatment visit , undergo the surgery , and attend both follow-up visits at 1 month 3 months post-operative care instructions provided by the surgical team.
. Data collection: The primary method for evaluating effectiveness will be the comparative analysis of the standardized photographs taken before the surgery and at the 1-month and 3-moths follow-up visits. clinical notes and your questionnaire responses will provide supporting data on safety and satisfaction.
. What are the expected benefits of participation? you may achieve an improved appearance and definition of the chin area through surgical procedure. this can enhance facial harmony and potentially boost your self-confidence.
What are the potential risks of participation? potential risks associated with this surgical procedure include, but are not limited to: bleeding, infection, noticeable scarring, adverse reactions to anesthesia, temporary or permanent nerve damage, irregularity in the jawline and neck contour changes in ear position
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical submental correction for Double chin | Experimental | Procedure: Evaluation of platysma muscle partial resection with midline plication for double chin correction |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 45 years and older.
- Systemic health : systemically healthy individuals (without significant systemic diseases), in good general health (ASA SCORE I OR II).
- Anatomical classification: participants classified as Type D according to Dedo Cervicomental angle classification (characterized by increased submental fat with platysma laxity and loss of angle definition due to both skin and fat).
- weight stability : proposed addition. stable weight loss.
Key exclusion criteria (16 listed)
- Age: under 45 years
- Systemic diseases: presence of uncontrolled or relevant systemic diseases affecting wound healing or outcomes
- anatomical classification: any Dedo classification other than type D (Type A,B,C).
- Relevant medical history :proposed addition.
- Medication and supplements: proposed addition.
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 |
|---|---|---|
| Evaluation of platysma muscle partial resection with midline plication for double chin correctionThe surgical procedure will be performed in two consecutive stages Phase one - midline correction: 1. submental liposuction : fat is aspirated from the submental region via a small puncture using a cannula. 2. Access expansion: the puncture entry is extended to form a small horizontal submental incision. 3. Dissection and exposure: the area is dissected through this incision using blunt dissection techniques to expose the midline platysma muscle. 4. Muscle excision: an elliptical segment of the platysma muscle is excised at the midline level. 5. Closure: the resulting muscular defect is closed with primary suturing. Phase two-lateral correction : 1. lateral access :the lateral aspect of the platysma muscle and the superficial musculoaponeurotic system is accessed via concealed peri-auricular incision 2. Plication and tightening: the platysma and smas are plicate and tighten along natural tension lines to lift the jawline and neck contours. 3. finally redundant skin excision and suturing. | Procedure or surgery | Surgical submental correction for Double chin |
Primary outcome
Cervicomental angle (in degrees) as measured using AutoCAD software.
Time frame: Measured at three time point : before treatment(baseline),1 month after treatment, and 3 moths after treatment.
The chin point( the lowest point on the chin in lateral view) and a point on the sternum(the highest prominent point of the sternum at the head) will be identified. Then, the point of the chin-neck junction(the lowest point of the curvature under the chin) will be determined. Subsequently, a line will be drawn connecting the chin point to the chin-neck junction point (the first side),and another line connecting the chin-neck junction point to sternum point(the second side) using the line tool in Adobe Photoshop. finally, the angel formed between these two sides will be measured using AutoCAD program.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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 Evaluation of platysma muscle partial resection with midline plication for double chin correction in people with Evaluation of Deep Plan Intervention in the Submental Region for Double Chin Management, run by Latakia University at 1 site in Syria.
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 4 inclusion and 16 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: finished, as of the sponsor's last update on 5 Feb 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 Syria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cervicomental angle (in degrees) as measured using AutoCAD software. (time frame: Measured at three time point : before treatment(baseline),1 month after treatment, and 3 moths after treatment.). 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 Feb 2026.