Double ChinNCT07864246
Evaluation and Management of Double Chin Submental Fat at Assiut University Hospital
An observational study of Double Chin, run by Assiut University.
Trial summary
Submental fat accumulation, commonly known as a "double chin," is a frequent aesthetic complaint affecting the lower face and neck and is often associated with aging, weight gain, or a genetic predisposition (1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Double Chin
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients Presenting with a cosmetic complaint of submental fullness/double chin, of any severity grade.
Who may be able to join
- Adult patients ≥ 18 years of age, either sex.
- Presenting with a cosmetic complaint of submental fullness/double chin, of any severity grade.
- Willing to give informed consent and to complete the scheduled follow-up visits.
- Able to undergo standardized clinical photography and, where applicable, ultrasound assessment.
Who cannot join
- • Previous submental surgical or minimally invasive procedures (liposuction, cryolipolysis, deoxycholic acid injections, thread lifting, energy-based device treatment).
- Pregnancy or lactation.
- Uncontrolled systemic disease (uncontrolled diabetes mellitus, bleeding/coagulation disorders, active malignancy).
- Active skin infection, keloidal tendency, or dermatologic disease within the submental treatment field.
- Current use of anticoagulant or antiplatelet therapy that cannot be safely withheld.
- Body mass index > 35 kg/m² (to minimize confounding by generalized obesity).
- Known body dysmorphic disorder, active psychiatric illness, or unrealistic aesthetic expectations, as assessed clinically.
- Refusal to provide consent or inability to complete the minimum follow-up period.
About this study
Submental fat accumulation, commonly known as a "double chin," is a frequent aesthetic complaint affecting the lower face and neck and is often associated with aging, weight gain, or a genetic predisposition (1). It develops from excess fat deposition in the superficial (pre-platysmal) and deep (post-platysmal) compartments of the neck (2), and can persist even in individuals of normal body weight owing to localized adipocyte hypertrophy that is resistant to diet and exercise (1). A large United States survey of adults aged 18-65 years found that 47% of respondents reported being bothered by the appearance of the area underneath their chin (3), and submental fullness has been consistently linked to lowered self-esteem and negative self-perception that motivate patients to seek treatment (1).
Several objective grading systems have been developed to standardize submental fat assessment. The Clinician-Reported and Patient-Reported Submental Fat Rating Scales, validated during the pivotal ATX-101 clinical trials, and an ethnicity-specific reference-photograph set derived from this scale later achieved inter-rater kappa values between 0.70 and 0.91 (4). Newer severity tools, including the Clinician Submental Fat Scale (5) and the Clinician-Chin Assessment Tool (6), have also been used to stratify patients before enrollment in pharmacologic trials.
Read more
Management options for submental fat span a wide spectrum. Injectable deoxycholic acid lipolysis has produced a significant reduction of submental fat in randomized placebo-controlled trials and meta-analyses, with a tolerable and mostly transient adverse-event profile, although a potential industry-sponsorship bias has been raised across the available trials (2). A newer injectable lipolytic agent achieved comparable improvement on clinician- and patient-reported scales, together with objective volume reduction on magnetic resonance imaging, in a large randomized Chinese cohort (7).
Cryolipolysis has similarly demonstrated efficacy for submental fat reduction, with pooled data from multiple pre-post studies showing a mean fat-thickness reduction of about 2.8 mm and a favorable safety profile (8), a finding corroborated by three-dimensional imaging analyses showing measurable volumetric loss and high patient satisfaction (9). Other non-invasive energy-based approaches, including combined focused-electrical-stimulation and radiofrequency devices, have been shown histologically to induce adipocyte apoptosis in the submental region (10). For patients with marked skin laxity or advanced neck-laxity grades, surgical techniques such as submental liposuction with platysma plication or resection remain the treatment of choice, as demonstrated in a recent submentoplasty cohort (10).
Given the absence of local Egyptian data comparing the full spectrum of double chin management options and the lack of information on the true burden of this condition among Egyptian patients, this cohort study is designed to systematically evaluate patients with submental fullness at Assiut University Hospital and to compare the effectiveness, safety, and patient satisfaction of the different available modalities, in order to generate evidence-based, locally relevant treatment guidance
- Conditions
- Double Chin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | patients Presenting with a cosmetic complaint of submental fullness/double chin, of any severity grade. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of reduction in submental fat
The degree of reduction in submental fat, measured objectively as the change in: cervicomental angle in degree
Measured: 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double ChinStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ashraf Mohamed Sleem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864246
- Sponsor's protocol ID
- Double Chin SubmentalFat
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2026
- Last updated
- 7 Oct 2026
- 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Management of Double Chin Submental Fat at Assiut University Hospital
- ClinicalTrials.gov ID
- NCT07864246
- Acronym / sponsor ID
- Double Chin SubmentalFat
- Conditions
- Double Chin
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Oct 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.
Submental fat accumulation, commonly known as a "double chin," is a frequent aesthetic complaint affecting the lower face and neck and is often associated with aging, weight gain, or a genetic predisposition (1). It develops from excess fat deposition in the superficial (pre-platysmal) and deep (post-platysmal) compartments of the neck (2), and can persist even in individuals of normal body weight owing to localized adipocyte hypertrophy that is resistant to diet and exercise (1). A large United States survey of adults aged 18-65 years found that 47% of respondents reported being bothered by the appearance of the area underneath their chin (3), and submental fullness has been consistently linked to lowered self-esteem and negative self-perception that motivate patients to seek treatment (1).
Several objective grading systems have been developed to standardize submental fat assessment. The Clinician-Reported and Patient-Reported Submental Fat Rating Scales, validated during the pivotal ATX-101 clinical trials, and an ethnicity-specific reference-photograph set derived from this scale later achieved inter-rater kappa values between 0.70 and 0.91 (4). Newer severity tools, including the Clinician Submental Fat Scale (5) and the Clinician-Chin Assessment Tool (6), have also been used to stratify patients before enrollment in pharmacologic trials.
Management options for submental fat span a wide spectrum. Injectable deoxycholic acid lipolysis has produced a significant reduction of submental fat in randomized placebo-controlled trials and meta-analyses, with a tolerable and mostly transient adverse-event profile, although a potential industry-sponsorship bias has been raised across the available trials (2). A newer injectable lipolytic agent achieved comparable improvement on clinician- and patient-reported scales, together with objective volume reduction on magnetic resonance imaging, in a large randomized Chinese cohort (7).
Cryolipolysis has similarly demonstrated efficacy for submental fat reduction, with pooled data from multiple pre-post studies showing a mean fat-thickness reduction of about 2.8 mm and a favorable safety profile (8), a finding corroborated by three-dimensional imaging analyses showing measurable volumetric loss and high patient satisfaction (9). Other non-invasive energy-based approaches, including combined focused-electrical-stimulation and radiofrequency devices, have been shown histologically to induce adipocyte apoptosis in the submental region (10). For patients with marked skin laxity or advanced neck-laxity grades, surgical techniques such as submental liposuction with platysma plication or resection remain the treatment of choice, as demonstrated in a recent submentoplasty cohort (10).
Given the absence of local Egyptian data comparing the full spectrum of double chin management options and the lack of information on the true burden of this condition among Egyptian patients, this cohort study is designed to systematically evaluate patients with submental fullness at Assiut University Hospital and to compare the effectiveness, safety, and patient satisfaction of the different available modalities, in order to generate evidence-based, locally relevant treatment guidance
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –patients Presenting with a cosmetic complaint of submental fullness/double chin, of any severity grade. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients Presenting with a cosmetic complaint of submental fullness/double chin, of any severity grade.
Key inclusion criteria (4 listed)
- Adult patients ≥ 18 years of age, either sex.
- Presenting with a cosmetic complaint of submental fullness/double chin, of any severity grade.
- Willing to give informed consent and to complete the scheduled follow-up visits.
- Able to undergo standardized clinical photography and, where applicable, ultrasound assessment.
Key exclusion criteria (8 listed)
- • Previous submental surgical or minimally invasive procedures (liposuction, cryolipolysis, deoxycholic acid injections, thread lifting, energy-based device treatment).
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
The degree of reduction in submental fat
Time frame: 12 weeks post-treatment
The degree of reduction in submental fat, measured objectively as the change in: cervicomental angle in degree
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 7 Oct 2026.
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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 Double Chin, run by Assiut University.
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 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: opening soon, as of the sponsor's last update on 7 Oct 2026. 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?
The degree of reduction in submental fat (time frame: 12 weeks post-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 7 Oct 2026.