Moderate or Severe Submental FullnessPhase 2NCT00618618
Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
A Phase 2 study testing Deoxycholic Acid Injection in people with Moderate or Severe Submental Fullness, run by Kythera Biopharmaceuticals at 7 sites in 3 countries.
Trial summary
Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin). Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Moderate or Severe Submental Fullness
- What is being tested?
- Deoxycholic Acid Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Apr 2008to Dec 2008
- Phase
- Phase 2
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Submental fat that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the submental fat (SMF) rating scale
- Good general health
- Signed informed consent
Who cannot join
- History of any treatment in the neck or chin area
- 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
7 sites in 3 countries.
7 sites in 3 countries
Canada4 sites
Investigational Site
Niagara Falls, Ontario, L2E 7H1
Investigational Site
Oakville, Ontario, L6J 7W5
Investigational Site
Toronto, Ontario, M4V 1R1
Investigational Site
Toronto, Ontario, M5S 3B4
Australia2 sites
Investigational Site
Sydney, 2000
Investigational Site
Toorak, Victoria, 3142
About this study
Official title: Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Given by Three Dosing Paradigms for the Reduction of Localized Subcutaneous Fat in the Submental Area
Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).
- Conditions
- Moderate or Severe Submental Fullness
- Being tested
- Deoxycholic Acid Injection, Placebo
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deoxycholic Acid InjectionDrug
Also called ATX-101
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Experimental | Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. Receives: Drug: Deoxycholic Acid Injection |
| Placebo 0.2 mL/0.7 cm | Placebo comparator | Participants received placebo administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. Receives: Drug: Placebo |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Experimental | Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. Receives: Drug: Deoxycholic Acid Injection |
| Placebo 0.2 mL/1.0 cm | Placebo comparator | Participants received placebo administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. Receives: Drug: Placebo |
| Deoxycholic Acid Injection 0.4 mL/1.0 cm | Experimental | Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. Receives: Drug: Deoxycholic Acid Injection |
| Placebo 0.4 mL/1.0 cm | Placebo comparator | Participants received placebo administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
The investigator determined the relationship of each adverse event to the administration of study drug.
Severity of adverse events was determined using the following scale:
- Mild: The participant is aware of a sign or symptom, but it is easily tolerated
- Moderate: Discomfort or interference with usual activity
- Severe: Incapacitating, with inability to engage in usual activity.
A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that:
- was fatal
- was life-threatening
- required inpatient hospitalization or prolongation of existing hospitalization
- resulted in persistent or significant disability/incapacity
- was a congenital anomaly/birth defect
- other significant medical hazard
Measured: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
Measured: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Secondary outcomes (8)
Change From Baseline in Submental Fat (SMF) Rating Scale Score
The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
A negative change from Baseline indicates improvement.
Measured: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Change From Baseline in Subject Satisfaction With Appearance Rating Scale
The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.
A positive change from Baseline indicates improvement.
Measured: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Percentage of Participants With a Response in the Subject Global Improvement Rating
Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause.
0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved.
Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6.
Measured: 4 weeks after last treatment (up to 16 weeks after first dose)
Percentage of Participants With an SMF Response
Response is defined as a participant with at least a 1-grade improvement in SMF Rating Scale score at Week 16 from Baseline. The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
Measured: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Change From Baseline in Skin Laxity Rating
Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale:
1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement.
Measured: Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score
The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
A negative change from Baseline indicates improvement.
Measured: Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
Change From Baseline in the Cervicomental Angle
The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.
Measured: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Visual Analogue Scale Pain Intensity Rating
Participants rated pain associated with the submental area on a 100 mm horizontal axis ranging from 0 (no pain) to 100 (most severe pain possible)
Measured: Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2008
- Study completionDec 2008
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 Moderate or Severe Submental FullnessStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kythera Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederick Beddingfield, III, M.D., Ph.D., Study director, Kythera Biopharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618618
- Sponsor's protocol ID
- ATX-101-07-07
- Other IDs
- 2007-006303-21
- Status last verified
- Jun 2015
- First submitted
- 8 Feb 2008
- Last updated
- 14 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Given by Three Dosing Paradigms for the Reduction of Localized Subcutaneous Fat in the Submental Area
- ClinicalTrials.gov ID
- NCT00618618
- Acronym / sponsor ID
- ATX-101-07-07
- Conditions
- Moderate or Severe Submental Fullness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Posted 15 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Experimental | Drug: Deoxycholic Acid InjectionParticipants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| Placebo 0.2 mL/0.7 cm | Placebo comparator | Drug: PlaceboParticipants received placebo administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Experimental | Drug: Deoxycholic Acid InjectionParticipants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| Placebo 0.2 mL/1.0 cm | Placebo comparator | Drug: PlaceboParticipants received placebo administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| Deoxycholic Acid Injection 0.4 mL/1.0 cm | Experimental | Drug: Deoxycholic Acid InjectionParticipants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| Placebo 0.4 mL/1.0 cm | Placebo comparator | Drug: PlaceboParticipants received placebo administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Submental fat that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the submental fat (SMF) rating scale
- Good general health
- Signed informed consent
Key exclusion criteria (4 listed)
- History of any treatment in the neck or chin area
- 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 |
|---|---|---|
| Deoxycholic Acid InjectionAlso: ATX-101Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL. | Drug | Deoxycholic Acid Injection 0.2 mL/0.7 cm, Deoxycholic Acid Injection 0.2 mL/1.0 cm, Deoxycholic Acid Injection 0.4 mL/1.0 cm |
| Placebo | Drug | Placebo 0.2 mL/0.7 cm, Placebo 0.2 mL/1.0 cm, Placebo 0.4 mL/1.0 cm |
Primary outcome
Number of Participants With Adverse Events
Time frame: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
The investigator determined the relationship of each adverse event to the administration of study drug. Severity of adverse events was determined using the following scale: * Mild: The participant is aware of a sign or symptom, but it is easily tolerated * Moderate: Discomfort or interference with usual activity * Severe: Incapacitating, with inability to engage in usual activity. A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that: * was fatal * was life-threatening * required inpatient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect * other significant medical hazard
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
Time frame: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
8 secondary outcomes
Change From Baseline in Submental Fat (SMF) Rating Scale Score
Time frame: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Change From Baseline in Subject Satisfaction With Appearance Rating Scale
Time frame: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Percentage of Participants With a Response in the Subject Global Improvement Rating
Time frame: 4 weeks after last treatment (up to 16 weeks after first dose)
Percentage of Participants With an SMF Response
Time frame: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Change From Baseline in Skin Laxity Rating
Time frame: Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score
Time frame: Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
Change From Baseline in the Cervicomental Angle
Time frame: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Visual Analogue Scale Pain Intensity Rating
Time frame: Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Moderate or Severe Submental Fullness
RecruitingPhase 1
A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation
Moderate or Severe Submental Fullness
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.
Frederick Beddingfield, III, M.D., Ph.D. study director
Kythera Biopharmaceuticals, Inc.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deoxycholic Acid Injection in people with Moderate or Severe Submental Fullness, run by Kythera Biopharmaceuticals at 7 sites in 3 countries.
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 3 inclusion and 4 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 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, Australia, United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Jun 2015). 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?
Number of Participants With Adverse Events (time frame: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).). 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 14 Jul 2015.