Submental FatPhase 2NCT04258761
A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin ("Double Chin")
A Phase 2 study testing 10XB-101 Solution for Injection in people with Submental Fat, run by 10xBio, LLC at 1 site in United States.
Trial summary
The purpose of this research study is to find out more about an investigational drug, 10XB-101, for people with fat under their chin which they would like to remove. The Sponsor of this study thinks there may be a chance this drug could be used to dissolve, or "melt" this fat away. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Submental Fat
- What is being tested?
- 10XB-101 Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2019to 31 Aug 2022
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a male or non-pregnant female 18-65 years of age
- Signed informed consent
- Subject has a score of 2 or 3 on the Clinician Submental Fat Scale (CSFS) at Visit 2/Baseline
- Subject is in good general health
Who cannot join
- Loose skin or prominent platysmal bands in the neck or chin area
- Recent treatment with anticoagulants
- Presence of clinically significant health problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Center, Open Label, Single Ascending Dose Safety and Tolerability Study of Subcutaneously Administered 10XB-101 in Adult Subjects With Excessive Submental Fat
The purpose of this research study is to find out more about an investigational drug, 10XB-101, for people with fat under their chin which they would like to remove. The Sponsor of this study thinks there may be a chance this drug could be used to dissolve, or "melt" this fat away.
Read the detailed description
About 15 subjects with excessive submental fat (SMF) will be enrolled across 2 sites in the United States.
- Conditions
- Submental Fat
- Being tested
- 10XB-101 Solution for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10XB-101 Solution for InjectionDrug
Also called polidocanol
Active test article
| Study group | Role | What they receive |
|---|---|---|
| 10XB-101 Solution for Injection 1.25% | Experimental | Participants receive 10XB-101 Solution for Injection, 1.25% via subcutaneous injection up to 10 mL on Day 1 of subject participation. Receives: Drug: 10XB-101 Solution for Injection |
| 10XB-101 Solution for Injection 2.0% | Experimental | Participants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation. Receives: Drug: 10XB-101 Solution for Injection |
| 10XB-101 Solution for Injection 3.0% | Experimental | Participants receive 10XB-101 Solution for Injection, 3.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation. Receives: Drug: 10XB-101 Solution for Injection |
| 10XB-101 Solution for Injection 4.5% | Experimental | Participants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL on Day 1 of subject participation. Receives: Drug: 10XB-101 Solution for Injection |
| 10XB-101 Solution for Injection 6.0% | Experimental | Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation. Receives: Drug: 10XB-101 Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidence (severity and causality) of any local and systemic Adverse Events
Measured: 24 weeks
Local Skin Reactions (LSR)
At each time point, the number of subjects with presence (and severity) of the following LSRs on a 4 point scale (zero to 3), with a higher score indicating a worse outcome: erythema, edema, tenderness on palpation, bruising, pain, and stinging/burning
Measured: 24 weeks
Secondary outcomes (2)
Clinician Submental Fat Scale (CSFS)
Change from Baseline in the CSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome
Measured: 24 weeks
Patient Submental Fat Scale (PSFS)
Change from Baseline in the PSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start10 Oct 2019
- Primary completion30 Jun 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Submental FatStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Multi-center, open label, single ascending dose comparison.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- 10xBio, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Dobak, MD, Study director, 10xBio, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258761
- Sponsor's protocol ID
- 210-9451-202
- Status last verified
- Apr 2024
- First submitted
- 27 Jan 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open Label, Single Ascending Dose Safety and Tolerability Study of Subcutaneously Administered 10XB-101 in Adult Subjects With Excessive Submental Fat
- ClinicalTrials.gov ID
- NCT04258761
- Acronym / sponsor ID
- 210-9451-202
- Conditions
- Submental Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- 10xBio, LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 6 Feb 2020 (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.
The purpose of this research study is to find out more about an investigational drug, 10XB-101, for people with fat under their chin which they would like to remove. The Sponsor of this study thinks there may be a chance this drug could be used to dissolve, or "melt" this fat away.
Detailed description
About 15 subjects with excessive submental fat (SMF) will be enrolled across 2 sites in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Multi-center, open label, single ascending dose comparison.
| Arm | Type | Receives |
|---|---|---|
| 10XB-101 Solution for Injection 1.25% | Experimental | Drug: 10XB-101 Solution for InjectionParticipants receive 10XB-101 Solution for Injection, 1.25% via subcutaneous injection up to 10 mL on Day 1 of subject participation. |
| 10XB-101 Solution for Injection 2.0% | Experimental | Drug: 10XB-101 Solution for InjectionParticipants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation. |
| 10XB-101 Solution for Injection 3.0% | Experimental | Drug: 10XB-101 Solution for InjectionParticipants receive 10XB-101 Solution for Injection, 3.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation. |
| 10XB-101 Solution for Injection 4.5% | Experimental | Drug: 10XB-101 Solution for InjectionParticipants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL on Day 1 of subject participation. |
| 10XB-101 Solution for Injection 6.0% | Experimental | Drug: 10XB-101 Solution for InjectionParticipants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is a male or non-pregnant female 18-65 years of age
- Signed informed consent
- Subject has a score of 2 or 3 on the Clinician Submental Fat Scale (CSFS) at Visit 2/Baseline
- Subject is in good general health
Key exclusion criteria (3 listed)
- Loose skin or prominent platysmal bands in the neck or chin area
- Recent treatment with anticoagulants
- Presence of clinically significant health problems
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 |
|---|---|---|
| 10XB-101 Solution for InjectionAlso: polidocanolActive test article | Drug | 10XB-101 Solution for Injection 1.25%, 10XB-101 Solution for Injection 2.0%, 10XB-101 Solution for Injection 3.0%, 10XB-101 Solution for Injection 4.5%, 10XB-101 Solution for Injection 6.0% |
Primary outcome
Adverse Events
Time frame: 24 weeks
Incidence (severity and causality) of any local and systemic Adverse Events
Local Skin Reactions (LSR)
Time frame: 24 weeks
At each time point, the number of subjects with presence (and severity) of the following LSRs on a 4 point scale (zero to 3), with a higher score indicating a worse outcome: erythema, edema, tenderness on palpation, bruising, pain, and stinging/burning
2 secondary outcomes
Clinician Submental Fat Scale (CSFS)
Time frame: 24 weeks
Patient Submental Fat Scale (PSFS)
Time frame: 24 weeks
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 10 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Submental Fat
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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. This study is not recruiting at the moment.
John Dobak, MD study director
10xBio, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10XB-101 Solution for Injection in people with Submental Fat, run by 10xBio, LLC at 1 site in United States.
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 3 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 10 Apr 2024. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adverse Events (time frame: 24 weeks). The study lists 2 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 10 Apr 2024.