Moderate or Severe Submental FullnessPhase 3NCT02007434
Patient Experience Study of Deoxycholic Acid Injection
A Phase 3 study testing Deoxycholic Acid Injection, Cold Compress and Lidocaine / Epinephrine in people with Moderate or Severe Submental Fullness, run by Kythera Biopharmaceuticals at 1 site in United States.
Trial summary
The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate or Severe Submental Fullness
- What is being tested?
- Deoxycholic Acid Injection, Cold Compress and Lidocaine / Epinephrine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jun 2014
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Submental fat graded by the Investigator as 2 (moderate) or 3 (severe) using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 (moderate amount) or 3 (large amount) using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
- Dissatisfaction with the appearance of the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS)
- History of stable body weight for at least 6 months and body mass index (BMI) of ≤ 40 kg/m².
- Acceptable skin laxity as determined by the investigator
- Agreement by the subject to refrain from making significant changes, in the documented judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation.
- Agreement to forego any treatment or behavior (e.g., unshaven facial hair)
- Signed informed consent obtained before any study-specific procedure is performed.
Who cannot join
- No prior intervention for submental fullness or recent cosmetic procedure in the neck or chin area
- Absence of clinically significant health problems
- Body mass index > 40.0 kg/m² as determined prior to randomization.
- History of drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Double-blind, Parallel-group, Two Factor Patient-Experience Management Study of ATX-101 (Deoxycholic Acid Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area
The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.
Read the detailed description
This study evaluated the effects of four interventions, pre- and post-subcutaneous injections of deoxycholic acid injection relative to placebo in adults with submental fullness. Participants were randomized to either deoxycholic acid injection or placebo in a ratio of 4:1 and to one of four patient experience management paradigms.
Participants were required to visit the research facility on 10 separate occasions for protocol-defined treatments, procedures, tests, and observations.
- Conditions
- Moderate or Severe Submental Fullness
- Being tested
- Deoxycholic Acid Injection, Placebo, Cold Compress, Lidocaine / Epinephrine, Loratadine
- 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, Kybella
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
PlaceboDrug
Phosphate buffered saline placebo for injection
Cold CompressOther
A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
Lidocaine / EpinephrineDrug
Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.
LoratadineDrug
Loratadine 10 mg orally from Day -7 until Day 7
IbuprofenDrug
Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.
Compression Chin StrapOther
A compression chin strap was applied 15 minutes after dosing for at least 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Experimental | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL (based on Baseline CR-SMFRS grade 2 or 3, respectively) on Day 0 and a cold compress applied to the treatment area. Receives: Drug: Deoxycholic Acid Injection; Other: Cold Compress |
| Paradigm 1/ Placebo | Placebo comparator | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area. Receives: Drug: Placebo; Other: Cold Compress |
| Paradigm 2 / Deoxycholic Acid Injection | Experimental | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area. Receives: Drug: Deoxycholic Acid Injection; Other: Cold Compress; Drug: Lidocaine / Epinephrine |
| Paradigm 2 / Placebo | Placebo comparator | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area. Receives: Drug: Placebo; Other: Cold Compress; Drug: Lidocaine / Epinephrine |
| Paradigm 3 / Deoxycholic Acid Injection | Experimental | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area. Receives: Drug: Deoxycholic Acid Injection; Other: Cold Compress; Drug: Lidocaine / Epinephrine; Drug: Loratadine; Drug: Ibuprofen |
| Paradigm 3 / Placebo | Placebo comparator | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. Receives: Drug: Placebo; Other: Cold Compress; Drug: Lidocaine / Epinephrine; Drug: Loratadine; Drug: Ibuprofen |
| Paradigm 4 / Deoxycholic Acid Injection | Experimental | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. Receives: Drug: Deoxycholic Acid Injection; Other: Cold Compress; Drug: Lidocaine / Epinephrine; Drug: Loratadine; Drug: Ibuprofen; Other: Compression Chin Strap |
| Paradigm 4 / Placebo | Placebo comparator | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. Receives: Drug: Placebo; Other: Cold Compress; Drug: Lidocaine / Epinephrine; Drug: Loratadine; Drug: Ibuprofen; Other: Compression Chin Strap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Visual Analog Scale Scores
Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. The scale ranged from 0 (no pain) to 100 (most severe pain possible).
Measured: Baseline and Day 84
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Participants rated 15 pain characteristics by using a number to signify how much of that specific type of pain they were experiencing using the Short-Form McGill Pain Questionnaire. The pain characteristic options included Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, and Punishing- cruel. Participants assessed the intensity of each characteristic using the following score system: none (0), mild (1), moderate (2), and severe (3). In addition, present pain was assessed on a scale from 0 (no pain) to 5 (excruciating).
Measured: Baseline (predose) and Day 84
Swelling Grading Scale Scores
The following grading system was used for the assessment of swelling:
- Swelling/edema absent (0)
- Minimal swelling/edema contained within treatment area (1)
- Modest swelling/edema contained within treatment area (2)
- Substantial swelling/edema contained within treatment area (3)
- Swelling/edema of the neck and face beyond the treatment area (4)
Measured: Day 84
Bruising Grading Scale Scores
The following grading system was used for the assessment of bruising:
- Bruising absent (0)
- Bruising associated with 1 to 3 needle insertion points (1)
- Bruising spreading beyond 4 or more individual needle insertion points but contained within the treatment area (2)
- Bruising covering the entire treatment area but contained within the treatment area (3)
- Bruising of the neck and face beyond the treatment area (4)
Measured: Day 84
Induration Grading Scale Scores
The following grading system was used for the assessment of induration:
- Induration absent to minimal (0)
- Induration associated with at least approximately 30% of the treatment area (1)
- Induration associated with greater than approximately 30% to at least 60% of the treatment area (2)
- Induration covering the entire treatment area but contained within the treatment area (3)
- Induration of the neck and face beyond the treatment area (4)
Measured: Day 84
Secondary outcomes (6)
Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
The CR-SMFRS 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 Day 84
Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement.
Measured: Baseline and Day 84
Change From Baseline in Subject Self Rating Scale (SSRS)
The SSRS assesses participant's 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 Day 84
Change From Baseline in Submental Skin Laxity Grades (SMSLG)
Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = mild laxity; 3 = moderate laxity; 4 = severe laxity. A negative change from Baseline indicates improvement.
Measured: Baseline and Day 84
Change From Baseline in Submental Fat Thickness
Submental thickness was measured using caliper devices.
Measured: Baseline and Day 84
Patient Experience Questions
Participants were asked to complete 3 patient experience questions, each answered as Yes or No:
Given your experience in this study:
- Would you recommend this procedure to a friend?
- Would you agree to receive additional treatments?
- Has the treatment you received in this study affected your normal activities?
The percentage of participants answering Yes on each question is reported.
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionJun 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kythera Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederick Beddingfield, III, MD, PhD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007434
- Sponsor's protocol ID
- ATX-101-13-36
- Status last verified
- Jul 2015
- First submitted
- 30 Oct 2013
- Last updated
- 28 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dover JS, Kenkel JM, Carruthers A, Lizzul PF, Gross TM, Subramanian M, Beddingfield FC 3rd. Management of Patient Experience With ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat. Dermatol Surg. 2016 Nov;42 Suppl 1:S288-S299. doi: 10.1097/DSS.0000000000000908.
PubMed 27787269
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Double-blind, Parallel-group, Two Factor Patient-Experience Management Study of ATX-101 (Deoxycholic Acid Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area
- ClinicalTrials.gov ID
- NCT02007434
- Acronym / sponsor ID
- ATX-101-13-36
- Conditions
- Moderate or Severe Submental Fullness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Posted 3 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.
Detailed description
This study evaluated the effects of four interventions, pre- and post-subcutaneous injections of deoxycholic acid injection relative to placebo in adults with submental fullness. Participants were randomized to either deoxycholic acid injection or placebo in a ratio of 4:1 and to one of four patient experience management paradigms.
Participants were required to visit the research facility on 10 separate occasions for protocol-defined treatments, procedures, tests, and observations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Experimental | Drug: Deoxycholic Acid Injection, Other: Cold CompressParticipants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL (based on Baseline CR-SMFRS grade 2 or 3, respectively) on Day 0 and a cold compress applied to the treatment area. |
| Paradigm 1/ Placebo | Placebo comparator | Drug: Placebo, Other: Cold CompressParticipants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area. |
| Paradigm 2 / Deoxycholic Acid Injection | Experimental | Drug: Deoxycholic Acid Injection, Other: Cold Compress, Drug: Lidocaine / EpinephrineParticipants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area. |
| Paradigm 2 / Placebo | Placebo comparator | Drug: Placebo, Other: Cold Compress, Drug: Lidocaine / EpinephrineParticipants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area. |
| Paradigm 3 / Deoxycholic Acid Injection | Experimental | Drug: Deoxycholic Acid Injection, Other: Cold Compress, Drug: Lidocaine / Epinephrine, Drug: Loratadine, Drug: IbuprofenParticipants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area. |
| Paradigm 3 / Placebo | Placebo comparator | Drug: Placebo, Other: Cold Compress, Drug: Lidocaine / Epinephrine, Drug: Loratadine, Drug: IbuprofenParticipants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
| Paradigm 4 / Deoxycholic Acid Injection | Experimental | Drug: Deoxycholic Acid Injection, Other: Cold Compress, Drug: Lidocaine / Epinephrine, Drug: Loratadine, Drug: Ibuprofen, Other: Compression Chin StrapParticipants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
| Paradigm 4 / Placebo | Placebo comparator | Drug: Placebo, Other: Cold Compress, Drug: Lidocaine / Epinephrine, Drug: Loratadine, Drug: Ibuprofen, Other: Compression Chin StrapParticipants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Submental fat graded by the Investigator as 2 (moderate) or 3 (severe) using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 (moderate amount) or 3 (large amount) using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
- Dissatisfaction with the appearance of the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS)
- History of stable body weight for at least 6 months and body mass index (BMI) of ≤ 40 kg/m².
- Acceptable skin laxity as determined by the investigator
- Agreement by the subject to refrain from making significant changes, in the documented judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation.
Key exclusion criteria (4 listed)
- No prior intervention for submental fullness or recent cosmetic procedure in the neck or chin area
- Absence of clinically significant health problems
- Body mass index > 40.0 kg/m² as determined prior to randomization.
- History of drug or alcohol abuse.
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-101, KybellaFormulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL. | Drug | Paradigm 1 / Deoxycholic Acid Injection, Paradigm 2 / Deoxycholic Acid Injection, Paradigm 3 / Deoxycholic Acid Injection, Paradigm 4 / Deoxycholic Acid Injection |
| PlaceboPhosphate buffered saline placebo for injection | Drug | Paradigm 1/ Placebo, Paradigm 2 / Placebo, Paradigm 3 / Placebo, Paradigm 4 / Placebo |
| Cold CompressA cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing. | Other | Paradigm 1 / Deoxycholic Acid Injection, Paradigm 1/ Placebo, Paradigm 2 / Deoxycholic Acid Injection, Paradigm 2 / Placebo, Paradigm 3 / Deoxycholic Acid Injection, Paradigm 3 / Placebo, Paradigm 4 / Deoxycholic Acid Injection, Paradigm 4 / Placebo |
| Lidocaine / EpinephrineLidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing. | Drug | Paradigm 2 / Deoxycholic Acid Injection, Paradigm 2 / Placebo, Paradigm 3 / Deoxycholic Acid Injection, Paradigm 3 / Placebo, Paradigm 4 / Deoxycholic Acid Injection, Paradigm 4 / Placebo |
| LoratadineLoratadine 10 mg orally from Day -7 until Day 7 | Drug | Paradigm 3 / Deoxycholic Acid Injection, Paradigm 3 / Placebo, Paradigm 4 / Deoxycholic Acid Injection, Paradigm 4 / Placebo |
| IbuprofenIbuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing. | Drug | Paradigm 3 / Deoxycholic Acid Injection, Paradigm 3 / Placebo, Paradigm 4 / Deoxycholic Acid Injection, Paradigm 4 / Placebo |
| Compression Chin StrapA compression chin strap was applied 15 minutes after dosing for at least 24 hours. | Other | Paradigm 4 / Deoxycholic Acid Injection, Paradigm 4 / Placebo |
Primary outcome
Change From Baseline in Pain Visual Analog Scale Scores
Time frame: Baseline and Day 84
Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. The scale ranged from 0 (no pain) to 100 (most severe pain possible).
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Time frame: Baseline (predose) and Day 84
Participants rated 15 pain characteristics by using a number to signify how much of that specific type of pain they were experiencing using the Short-Form McGill Pain Questionnaire. The pain characteristic options included Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, and Punishing- cruel. Participants assessed the intensity of each characteristic using the following score system: none (0), mild (1), moderate (2), and severe (3). In addition, present pain was assessed on a scale from 0 (no pain) to 5 (excruciating).
Swelling Grading Scale Scores
Time frame: Day 84
The following grading system was used for the assessment of swelling: * Swelling/edema absent (0) * Minimal swelling/edema contained within treatment area (1) * Modest swelling/edema contained within treatment area (2) * Substantial swelling/edema contained within treatment area (3) * Swelling/edema of the neck and face beyond the treatment area (4)
Bruising Grading Scale Scores
Time frame: Day 84
The following grading system was used for the assessment of bruising: * Bruising absent (0) * Bruising associated with 1 to 3 needle insertion points (1) * Bruising spreading beyond 4 or more individual needle insertion points but contained within the treatment area (2) * Bruising covering the entire treatment area but contained within the treatment area (3) * Bruising of the neck and face beyond the treatment area (4)
Induration Grading Scale Scores
Time frame: Day 84
The following grading system was used for the assessment of induration: * Induration absent to minimal (0) * Induration associated with at least approximately 30% of the treatment area (1) * Induration associated with greater than approximately 30% to at least 60% of the treatment area (2) * Induration covering the entire treatment area but contained within the treatment area (3) * Induration of the neck and face beyond the treatment area (4)
6 secondary outcomes
Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
Time frame: Baseline and Day 84
Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
Time frame: Baseline and Day 84
Change From Baseline in Subject Self Rating Scale (SSRS)
Time frame: Baseline and Day 84
Change From Baseline in Submental Skin Laxity Grades (SMSLG)
Time frame: Baseline and Day 84
Change From Baseline in Submental Fat Thickness
Time frame: Baseline and Day 84
Patient Experience Questions
Time frame: Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27787269Dover JS, Kenkel JM, Carruthers A, Lizzul PF, Gross TM, Subramanian M, Beddingfield FC 3rd. Management of Patient Experience With ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat. Dermatol Surg. 2016 Nov;42 Suppl 1:S288-S299. doi: 10.1097/DSS.0000000000000908.
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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.
Frederick Beddingfield, III, MD, PhD study director
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Deoxycholic Acid Injection, Cold Compress and Lidocaine / Epinephrine in people with Moderate or Severe Submental Fullness, run by Kythera Biopharmaceuticals 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 7 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 28 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 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 3 Jul 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?
Change From Baseline in Pain Visual Analog Scale Scores (time frame: Baseline and Day 84). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02007434, which also lists 1 linked publication.
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 28 Jul 2015.