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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change From Baseline in Pain Visual Analog Scale Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Paradigm 1 / Deoxycholic Acid Injection
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.
干预措施: Deoxycholic Acid Injection (Drug)
Paradigm 1 / Deoxycholic Acid Injection
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.
干预措施: Cold Compress (Other)
Paradigm 1/ Placebo
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.
干预措施: Placebo (Drug)
Paradigm 1/ Placebo
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.
干预措施: Cold Compress (Other)
Paradigm 2 / Deoxycholic Acid Injection
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.
干预措施: Deoxycholic Acid Injection (Drug)
Paradigm 2 / Deoxycholic Acid Injection
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.
干预措施: Cold Compress (Other)
Paradigm 2 / Deoxycholic Acid Injection
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.
干预措施: Lidocaine / Epinephrine (Drug)
Paradigm 2 / Placebo
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.
干预措施: Placebo (Drug)
Paradigm 2 / Placebo
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.
干预措施: Cold Compress (Other)
Paradigm 2 / Placebo
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.
干预措施: Lidocaine / Epinephrine (Drug)
Paradigm 3 / Deoxycholic Acid Injection
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.
干预措施: Deoxycholic Acid Injection (Drug)
Paradigm 3 / Deoxycholic Acid Injection
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.
干预措施: Cold Compress (Other)
Paradigm 3 / Deoxycholic Acid Injection
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.
干预措施: Lidocaine / Epinephrine (Drug)
Paradigm 3 / Deoxycholic Acid Injection
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.
干预措施: Loratadine (Drug)
Paradigm 3 / Deoxycholic Acid Injection
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.
干预措施: Ibuprofen (Drug)
Paradigm 3 / Placebo
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.
干预措施: Placebo (Drug)
Paradigm 3 / Placebo
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.
干预措施: Cold Compress (Other)
Paradigm 3 / Placebo
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.
干预措施: Lidocaine / Epinephrine (Drug)
Paradigm 3 / Placebo
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.
干预措施: Loratadine (Drug)
Paradigm 3 / Placebo
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.
干预措施: Ibuprofen (Drug)
Paradigm 4 / Deoxycholic Acid Injection
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.
干预措施: Deoxycholic Acid Injection (Drug)
Paradigm 4 / Deoxycholic Acid Injection
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.
干预措施: Cold Compress (Other)
Paradigm 4 / Deoxycholic Acid Injection
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.
干预措施: Lidocaine / Epinephrine (Drug)
Paradigm 4 / Deoxycholic Acid Injection
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.
干预措施: Loratadine (Drug)
Paradigm 4 / Deoxycholic Acid Injection
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.
干预措施: Ibuprofen (Drug)
Paradigm 4 / Deoxycholic Acid Injection
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.
干预措施: Compression Chin Strap (Other)
Paradigm 4 / Placebo
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.
干预措施: Placebo (Drug)
Paradigm 4 / Placebo
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.
干预措施: Cold Compress (Other)
Paradigm 4 / Placebo
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.
干预措施: Lidocaine / Epinephrine (Drug)
Paradigm 4 / Placebo
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.
干预措施: Loratadine (Drug)
Paradigm 4 / Placebo
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.
干预措施: Ibuprofen (Drug)
Paradigm 4 / Placebo
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.
干预措施: Compression Chin Strap (Other)
结局指标
主要结局
Change From Baseline in Pain Visual Analog Scale Scores
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)(Baseline and Day 84)
- Change From Baseline in Subject Self Rating Scale (SSRS)(Baseline and Day 84)
- Change From Baseline in Submental Skin Laxity Grades (SMSLG)(Baseline and Day 84)
- Change From Baseline in Submental Fat Thickness(Baseline and Day 84)
- Patient Experience Questions(Day 84)
- Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)(Baseline and Day 84)