Patient Experience Study of Deoxycholic Acid Injection

Moderate or Severe Submental Fullness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007434
• Other study ID #: ATX-101-13-36
• Status: Completed
• Phase: Phase 3
• First received: October 30, 2013
• Last updated: July 6, 2015
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2015
• Source: Kythera Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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)

2. 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)

3. History of stable body weight for at least 6 months and body mass index (BMI) of = 40 kg/m².

4. Acceptable skin laxity as determined by the investigator

5. 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.

6. Agreement to forego any treatment or behavior (e.g., unshaven facial hair)

7. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

1. No prior intervention for submental fullness or recent cosmetic procedure in the neck or chin area

2. Absence of clinically significant health problems

3. Body mass index > 40.0 kg/m² as determined prior to randomization.

4. History of drug or alcohol abuse.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Moderate or Severe Submental Fullness

Intervention

Drug:
• Deoxycholic Acid Injection
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
• Placebo
Phosphate buffered saline placebo for injection

Other:
• Cold Compress
A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.

Drug:
• Lidocaine / Epinephrine
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.
• Loratadine
Loratadine 10 mg orally from Day -7 until Day 7
• Ibuprofen
Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.

Other:
• Compression Chin Strap
A compression chin strap was applied 15 minutes after dosing for at least 24 hours.

Locations

Country	Name	City	State
United States	Investigational Site	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Kythera Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and Day 84	No
Primary	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).	Baseline (predose) and Day 84	No
Primary	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)	Day 84	No
Primary	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)	Day 84	No
Primary	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)	Day 84	No
Secondary	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.	Baseline and Day 84	No
Secondary	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.	Baseline and Day 84	No
Secondary	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.	Baseline and Day 84	No
Secondary	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.	Baseline and Day 84	No
Secondary	Change From Baseline in Submental Fat Thickness	Submental thickness was measured using caliper devices.	Baseline and Day 84	No
Secondary	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.	Day 84	No