Fat ReductionPhase 4NCT03241563
Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat
A Phase 4 study testing Sodium Deoxycholate and Triamcinolone in people with Fat Reduction, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
The subjects and evaluating investigator will be blinded to the treatment, thus maintaining double-blind status. By nature of the varying volumes of injection, the treating investigator will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced 4 weeks apart. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fat Reduction
- What is being tested?
- Sodium Deoxycholate and Triamcinolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Feb 2017
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Females or Males in good general health age 18 - 65 years of age
- 2. Fitzpatrick skin types I-VI
- 3. Must be willing to give and sign a HIPPA form and informed consent form
- 4. Must be willing and able to comply with all study protocols and schedules
- 5. Must have submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (PR-SMFRS)
- 6. Negative urine pregnancy test prior to each treatment (if applicable)
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- 7. Female patients will be either of non-childbearing potential defined as: 7.1 Having no uterus 7.2 No menses for at least 12 months. Or; (WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as: 7.3 Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device 7.4 Intrauterine coil 7.5 Bilateral tubal ligation 7.6 Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom) 7.7 Abstinence (If practicing abstinence must agree to use barrier method described above (7.6) if becomes sexually active) 7.8 Vasectomized partner (must agree to use barrier method described above (7.6) if becomes sexually active with unvasectomized partner)
- 8. Males must be willing to be clean shaven for all study visits
- 9. The patient must have had a stable weight (no fluctuation of >15 pounds in a year), diet, and physical activity for the previous 6 months
Who cannot join
- 1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial
- 2. Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- 3. Treatment with botulinum toxin injections in the neck or chin area within 6 months before randomization
- 4. Any Scars, unshaven hair, tattoos or jewelry on or near the proposed treatment area
- 5. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study
- 6. An active dermatitis or open wound in the proposed treatment area
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- 7. An active bacterial, fungal, or viral infection in the proposed treatment area
- 8. Pre-existing skin condition to the submental region that may confound evaluation or analysis, at investigator discretion
- 9. Previously treated with subcutaneous sodium deoxycholate to the submental region
- 10. Previously treated with focused ultrasound, radiofrequency, cryolipolysis or liposuction to the submental region within the previous 6 months
- 11. Any other laser, light energy device, or chemical peel treatment to the submental region within the previous 3 months
- 12. Pre-existing neurological or gastrointestinal condition leading to dysphagia, dysphonia or facial nerve palsy
- 13. Pre-existing medical condition other than increased submental fat that may result in increased submental fullness such as but not limited to thyroid enlargement, goiter, cervical lymphadenopathy etc., at investigator discretion
- 14. Must not have a planned fat reduction procedure of any variety to the submental region for the duration of the study
- 15. Must not have planned significant alterations in diet or physical activity that may result in significant fluctuations in weight
- 16. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California, 92121
About this study
Official title: A Randomized, Double-blind Comparison Trial of Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat
The subjects and evaluating investigator will be blinded to the treatment, thus maintaining double-blind status. By nature of the varying volumes of injection, the treating investigator will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced 4 weeks apart.
Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow up visits will be performed 3 and 5 days after each injection session to assess for side effect and tolerability profile. After the final injection session, additional follow up visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be recorded at baseline and at end of study.
Read the detailed description
This is a Single-site randomized, double-blind comparison trial of Kybella injections with or without triamcinolone acetate for the reduction of submental fat. 20 subjects will be enrolled into the trial. Of these 20 subjects, 5 will be randomized to receive Kybella injections alone whereas 15 will receive Kybella plus triamcinolone acetate in the following way:
- Kybella alone: 2 mg/cm2 of Kybella will be delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total dose of up to 100 mg of sodium deoxycholate.
- Kybella plus triamcinolone: 0.2 mL of 2 mg/cm2 of Kybella will be mixed with 0.05 mL of 40 mg/mL of triamcinolone acetate and then delivered in up to 50 injections spaced 1.0 cm apart at 0.25 mL/injection for a total dose of up to 100 mg of sodium deoxycholate using a 30 gauge (or smaller) 0.5-inch needle.
The treatment area will be bounded superiorly by a line 1 cm inferior to the mandibular margin, laterally by the sternocleidomastoid muscles, and inferiorly by the hyoid bone. The subjects and evaluating investigator will be blinded to the treatment, thus maintaining double-blind status. By nature of the varying volumes of injection, the treating investigator will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced 4 weeks apart.
Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow up visits will be performed 3 and 5 days after each injection session to assess for side effect and tolerability profile. After the final injection session, additional follow up visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be recorded at baseline and at end of study.
- Conditions
- Fat Reduction
- Being tested
- Sodium Deoxycholate, Triamcinolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium DeoxycholateDrug
Also called Kybella
TriamcinoloneDrug
Triamcinolone 40mg/ml
| Study group | Role | What they receive |
|---|---|---|
| without triamcinolone | Active comparator | sodium Deoxycholate without triamcinolone Receives: Drug: Sodium Deoxycholate |
| with triamcinolone | Active comparator | sodium Deoxycholate with triamcinolone Receives: Drug: Sodium Deoxycholate; Drug: Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Efficacy of Kybella with Triamcinolone in the Reduction of Submental Fat
evaluate the efficacy associated with Kybella injections for the reduction of fat of the upper neck in the treatment of submental fat with and without added triamcinolone acetonide. An evaluator blinded to the study will grade the level of improvement of the submental fat using the Clinician Graded Submental Fat Rating Scale.
Measured: 6 Months
Secondary outcomes (1)
Evaluation of Safety of Kybella with Triamcinolone for Reduction of Submental Fat
Differences in rates of edema, erythema, tenderness, and erosion/ulceration, based on blinded evaluator assessment, will be compared between subjects treated with Kybella with and without triamcinolone
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study startApr 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat ReductionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Mitchel P Goldman, MD, Principal investigator, DCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241563
- Sponsor's protocol ID
- ATX-TRIAM-2016
- Status last verified
- Aug 2017
- First submitted
- 2 Mar 2017
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Comparison Trial of Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat
- ClinicalTrials.gov ID
- NCT03241563
- Acronym / sponsor ID
- ATX-TRIAM-2016
- Conditions
- Fat Reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Apr 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 7 Aug 2017 (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 subjects and evaluating investigator will be blinded to the treatment, thus maintaining double-blind status. By nature of the varying volumes of injection, the treating investigator will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced 4 weeks apart.
Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow up visits will be performed 3 and 5 days after each injection session to assess for side effect and tolerability profile. After the final injection session, additional follow up visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be recorded at baseline and at end of study.
Detailed description
This is a Single-site randomized, double-blind comparison trial of Kybella injections with or without triamcinolone acetate for the reduction of submental fat. 20 subjects will be enrolled into the trial. Of these 20 subjects, 5 will be randomized to receive Kybella injections alone whereas 15 will receive Kybella plus triamcinolone acetate in the following way:
- Kybella alone: 2 mg/cm2 of Kybella will be delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total dose of up to 100 mg of sodium deoxycholate.
- Kybella plus triamcinolone: 0.2 mL of 2 mg/cm2 of Kybella will be mixed with 0.05 mL of 40 mg/mL of triamcinolone acetate and then delivered in up to 50 injections spaced 1.0 cm apart at 0.25 mL/injection for a total dose of up to 100 mg of sodium deoxycholate using a 30 gauge (or smaller) 0.5-inch needle.
The treatment area will be bounded superiorly by a line 1 cm inferior to the mandibular margin, laterally by the sternocleidomastoid muscles, and inferiorly by the hyoid bone. The subjects and evaluating investigator will be blinded to the treatment, thus maintaining double-blind status. By nature of the varying volumes of injection, the treating investigator will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced 4 weeks apart.
Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow up visits will be performed 3 and 5 days after each injection session to assess for side effect and tolerability profile. After the final injection session, additional follow up visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be recorded at baseline and at end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| without triamcinolone | Active comparator | Drug: Sodium Deoxycholatesodium Deoxycholate without triamcinolone |
| with triamcinolone | Active comparator | Drug: Sodium Deoxycholate, Drug: Triamcinolonesodium Deoxycholate with triamcinolone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Females or Males in good general health age 18 - 65 years of age
- 2. Fitzpatrick skin types I-VI
- 3. Must be willing to give and sign a HIPPA form and informed consent form
- 4. Must be willing and able to comply with all study protocols and schedules
- 5. Must have submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (PR-SMFRS)
Key exclusion criteria (16 listed)
- 1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial
- 2. Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- 3. Treatment with botulinum toxin injections in the neck or chin area within 6 months before randomization
- 4. Any Scars, unshaven hair, tattoos or jewelry on or near the proposed treatment area
- 5. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study
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 |
|---|---|---|
| Sodium DeoxycholateAlso: Kybella | Drug | with triamcinolone, without triamcinolone |
| TriamcinoloneTriamcinolone 40mg/ml | Drug | with triamcinolone |
Primary outcome
Evaluation of Efficacy of Kybella with Triamcinolone in the Reduction of Submental Fat
Time frame: 6 Months
evaluate the efficacy associated with Kybella injections for the reduction of fat of the upper neck in the treatment of submental fat with and without added triamcinolone acetonide. An evaluator blinded to the study will grade the level of improvement of the submental fat using the Clinician Graded Submental Fat Rating Scale.
1 secondary outcome
Evaluation of Safety of Kybella with Triamcinolone for Reduction of Submental Fat
Time frame: 6 months
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 7 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Mitchel P Goldman, MD principal investigator
DCLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Deoxycholate and Triamcinolone in people with Fat Reduction, run by Goldman, Butterwick, Fitzpatrick and Groff 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 9 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 7 Aug 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluation of Efficacy of Kybella with Triamcinolone in the Reduction of Submental Fat (time frame: 6 Months). 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 Aug 2017.