AdiposityPhase 4NCT03361176
Kybella With Triamcinolone
A Phase 4 study testing Injectable sodium deoxycholate and Injectable sodium deoxycholate with Triamcinolone acetate in people with Adiposity, run by Goldman, Butterwick, Fitzpatrick and Groff at 2 sites in United States.
Trial summary
This study is to evaluate the efficacy, edema and pain associated with Kybella(TM) injections of the upper neck in the treatment of submental fat with varying low concentrations of triamcinolone acetonide plus low doses of lidocaine. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adiposity
- What is being tested?
- Injectable sodium deoxycholate and Injectable sodium deoxycholate with Triamcinolone acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Mar 2018to 18 Dec 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Females or Males in good general health age 18 - 65 years of age
- Fitzpatrick skin types I-VI
- Must be willing to give and sign a HIPAA form and informed consent form
- Must be willing and able to comply with all study protocols and schedules
- Must have submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (PR-SMFRS)
- Negative urine pregnancy test prior to each treatment (if applicable)
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- 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)
- Males must be willing to be clean shaven for all study visits
- 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
- Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial
- 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
- Treatment with botulinum toxin injections in the neck or chin area within 6 months before randomization
- Any Scars, unshaven hair, tattoos or jewelry on or near the proposed treatment area
- Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study
- An active dermatitis or open wound in the proposed treatment area
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- An active bacterial, fungal, or viral infection in the proposed treatment area
- Pre-existing skin condition to the submental region that may confound evaluation or analysis, at investigator discretion
- Previously treated with subcutaneous sodium deoxycholate to the submental region
- Previously treated with focused ultrasound, radiofrequency, cryolipolysis or liposuction to the submental region within the previous 6 months
- Any other laser, light energy device, or chemical peel treatment to the submental region within the previous 3 months
- Pre-existing neurological or gastrointestinal condition leading to dysphagia, dysphonia or facial nerve palsy
- 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
- Must not have a planned fat reduction procedure of any variety to the submental region for the duration of the study
- Must not have planned significant alterations in diet or physical activity that may result in significant fluctuations in weight
- 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
2 sites in 1 country.
United States2 sites
Maryland Dermatology Laser, Skin and Vein Institute
Hunt Valley, Maryland, 21030
West Dermatology Research Center
San Diego, California, 92121
About this study
Official title: A Randomized, Double-blind, Dose-ranging Trial of Subcutaneous Sodium Deoxycholate Injections With or Without Low Dose Triamcinolone and Low Dose Lidocaine for Reduction of Submental Fat With Reduction of Pain and Swelling
This study is to evaluate the efficacy, edema and pain associated with Kybella(TM) injections of the upper neck in the treatment of submental fat with varying low concentrations of triamcinolone acetonide plus low doses of lidocaine.
Read the detailed description
This is a two-site randomized, double-blind comparison trial of Kybella(TM) injections with or without triamcinolone acetate for the reduction of submental fat. 30 subjects will be enrolled into the trial (15 subjects per site). At each site, 5 will be randomized to receive Kybella(TM) injections alone whereas 10 will receive Kybella(TM) plus differing doses of triamcinolone acetate in the following way:
- Group 1 (5 patients per site): Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline to the non-TMC group to maintain equal concentrations in each injection so that the final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point will be delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total maximal dose of up to 100 mg of SDOC.
- Group 2 (10 patients per site): Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate, 0.2 mL of 1% lidocaine with no epinephrine and then 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 SDOC using a 30 gauge (or smaller) 0.5-inch needle. The final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point
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. No lidocaine will be injected prior to injections to prevent further dilution of injected Kybella™ as it will be premixed with Kybella™. Chilling with cold will be the method of pain reduction for needle insertion.
Canfield Vectra 3D imaging will be performed at baseline and final visit (Appendix C) with analysis and calculation of volumetric changes performed at baseline and final visit. Photos will also be taken with the Intellistudio at all other visits. 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
- Adiposity
- Being tested
- Injectable sodium deoxycholate, Injectable sodium deoxycholate with Triamcinolone acetate
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable sodium deoxycholateDrug
Also called Kybella
Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline to the non-TMC group to maintain equal concentrations in each injection so that the final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point will be delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total maximal dose of up to 100 mg of SDOC.
Injectable sodium deoxycholate with Triamcinolone acetateCombination product
Also called Kybella with Triamcinolone Acetate
Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate, 0.2 mL of 1% lidocaine with no epinephrine and then 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 SDOC using a 30 gauge (or smaller) 0.5-inch needle. The final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control Group (5 patients per site): Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline delivered in up to 50 injections per treatment session. Receives: Drug: Injectable sodium deoxycholate |
| w/ Triamcinolone | Experimental | Experimental Group (10 patients per site): Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate and 0.2 mL of 1% lidocaine with no epinephrine delivered in up to 50 injections per treatment session. Receives: Combination Product: Injectable sodium deoxycholate with Triamcinolone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician-Reported Submental Fat Rating Scale
Change in efficacy will be measured from Baseline to 90 days post final treatment using a 5-point Clinician-Reported Submental Fat Rating Scale ranging from Absent (score of 0) to Extreme submental convexity (score of 4)
Measured: 90 Days from Baseline
Secondary outcomes (2)
Change in Clinician-Reported Submental Laxity Rating Scale
Laxity will be compared between treatment groups at each post-treatment time point through Day 90 using a 5-Point Clinician Evaluation of Side Effects Scale ranging from None (score of 0) to Severe (score of 4).
Measured: 90 days from baseline
Subject Satisfaction Rating Scale
Satisfaction will be compared between treatment groups at each post-treatment time point through Day 180 using a 7-point satisfaction scale rating from extremely dissatisfied (score of 0) to extremely satisfied (score of 6).
Measured: Post-treatment to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start26 Mar 2018
- Primary completion12 Oct 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AdiposityStudies 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
- Model description
- 10 subjects will be part of a control group treated without triamcinolone and 20 subjects will be treated with triamcinolone.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan, Maryland Laser Skin and Vein Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361176
- Sponsor's protocol ID
- Kybelladose-2017-02
- Status last verified
- May 2019
- First submitted
- 21 Nov 2017
- Last updated
- 9 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Dose-ranging Trial of Subcutaneous Sodium Deoxycholate Injections With or Without Low Dose Triamcinolone and Low Dose Lidocaine for Reduction of Submental Fat With Reduction of Pain and Swelling
- ClinicalTrials.gov ID
- NCT03361176
- Acronym / sponsor ID
- Kybelladose-2017-02
- Conditions
- Adiposity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- Allergan, Maryland Laser Skin and Vein Institute
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 12 Oct 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Posted 9 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the efficacy, edema and pain associated with Kybella(TM) injections of the upper neck in the treatment of submental fat with varying low concentrations of triamcinolone acetonide plus low doses of lidocaine.
Detailed description
This is a two-site randomized, double-blind comparison trial of Kybella(TM) injections with or without triamcinolone acetate for the reduction of submental fat. 30 subjects will be enrolled into the trial (15 subjects per site). At each site, 5 will be randomized to receive Kybella(TM) injections alone whereas 10 will receive Kybella(TM) plus differing doses of triamcinolone acetate in the following way:
- Group 1 (5 patients per site): Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline to the non-TMC group to maintain equal concentrations in each injection so that the final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point will be delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total maximal dose of up to 100 mg of SDOC.
- Group 2 (10 patients per site): Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate, 0.2 mL of 1% lidocaine with no epinephrine and then 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 SDOC using a 30 gauge (or smaller) 0.5-inch needle. The final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point
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. No lidocaine will be injected prior to injections to prevent further dilution of injected Kybella™ as it will be premixed with Kybella™. Chilling with cold will be the method of pain reduction for needle insertion.
Canfield Vectra 3D imaging will be performed at baseline and final visit (Appendix C) with analysis and calculation of volumetric changes performed at baseline and final visit. Photos will also be taken with the Intellistudio at all other visits. 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
- Model description
- 10 subjects will be part of a control group treated without triamcinolone and 20 subjects will be treated with triamcinolone.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Injectable sodium deoxycholateControl Group (5 patients per site): Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline delivered in up to 50 injections per treatment session. |
| w/ Triamcinolone | Experimental | Combination Product: Injectable sodium deoxycholate with Triamcinolone acetateExperimental Group (10 patients per site): Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate and 0.2 mL of 1% lidocaine with no epinephrine delivered in up to 50 injections per treatment session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Females or Males in good general health age 18 - 65 years of age
- Fitzpatrick skin types I-VI
- Must be willing to give and sign a HIPAA form and informed consent form
- Must be willing and able to comply with all study protocols and schedules
- 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)
- Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial
- 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
- Treatment with botulinum toxin injections in the neck or chin area within 6 months before randomization
- Any Scars, unshaven hair, tattoos or jewelry on or near the proposed treatment area
- 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 |
|---|---|---|
| Injectable sodium deoxycholateAlso: KybellaKybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline to the non-TMC group to maintain equal concentrations in each injection so that the final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point will be delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total maximal dose of up to 100 mg of SDOC. | Drug | Control |
| Injectable sodium deoxycholate with Triamcinolone acetateAlso: Kybella with Triamcinolone AcetateKybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate, 0.2 mL of 1% lidocaine with no epinephrine and then 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 SDOC using a 30 gauge (or smaller) 0.5-inch needle. The final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point | Combination product | w/ Triamcinolone |
Primary outcome
Change in Clinician-Reported Submental Fat Rating Scale
Time frame: 90 Days from Baseline
Change in efficacy will be measured from Baseline to 90 days post final treatment using a 5-point Clinician-Reported Submental Fat Rating Scale ranging from Absent (score of 0) to Extreme submental convexity (score of 4)
2 secondary outcomes
Change in Clinician-Reported Submental Laxity Rating Scale
Time frame: 90 days from baseline
Subject Satisfaction Rating Scale
Time frame: Post-treatment to Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Injectable sodium deoxycholate and Injectable sodium deoxycholate with Triamcinolone acetate in people with Adiposity, run by Goldman, Butterwick, Fitzpatrick and Groff at 2 sites 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 10 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 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 9 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Clinician-Reported Submental Fat Rating Scale (time frame: 90 Days from Baseline). 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 9 May 2019.