Patient Experience Study of Deoxycholic Acid Injection

NCT02007434 | Completed Phase 3 Results

• 1 other identifier: ATX-101-13-36
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moderate or Severe Submental Fullness

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (6)

• Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)

  Baseline and Day 84

• Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-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

Study Arms (8)

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.

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.

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.

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.

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.

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.

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.

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.

Drug: Placebo; Other: Cold Compress; Drug: Lidocaine / Epinephrine; Drug: Loratadine; Drug: Ibuprofen; Other: Compression Chin Strap

Interventions

Deoxycholic Acid Injection DRUG

Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.

Also known as: ATX-101, Kybella

Paradigm 1 / Deoxycholic Acid Injection; Paradigm 2 / Deoxycholic Acid Injection; Paradigm 3 / Deoxycholic Acid Injection; Paradigm 4 / Deoxycholic Acid Injection

Placebo DRUG

Phosphate buffered saline placebo for injection

Paradigm 1/ Placebo; Paradigm 2 / Placebo; Paradigm 3 / Placebo; Paradigm 4 / Placebo

Cold Compress OTHER

A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.

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 / Epinephrine DRUG

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.

Paradigm 2 / Deoxycholic Acid Injection; Paradigm 2 / Placebo; Paradigm 3 / Deoxycholic Acid Injection; Paradigm 3 / Placebo; Paradigm 4 / Deoxycholic Acid Injection; Paradigm 4 / Placebo

Loratadine DRUG

Loratadine 10 mg orally from Day -7 until Day 7

Paradigm 3 / Deoxycholic Acid Injection; Paradigm 3 / Placebo; Paradigm 4 / Deoxycholic Acid Injection; Paradigm 4 / Placebo

Ibuprofen DRUG

Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.

Paradigm 3 / Deoxycholic Acid Injection; Paradigm 3 / Placebo; Paradigm 4 / Deoxycholic Acid Injection; Paradigm 4 / Placebo

Compression Chin Strap OTHER

A compression chin strap was applied 15 minutes after dosing for at least 24 hours.

Paradigm 4 / Deoxycholic Acid Injection; Paradigm 4 / Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kythera Biopharmaceuticals: lead

Study Sites (1)

Investigational Site

Tempe, Arizona, 85283, United States

Location

Related Publications (1)

• 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.

  PMID: 27787269 DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Deoxycholic Acid; Lidocaine; Epinephrine; Loratadine; Ibuprofen

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Clinical Trial Disclosure
• Organization: Kythera

clinical_trials@kythera.com

Study Officials

• Frederick Beddingfield, III, MD, PhD

  Sponsor GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: December 10, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 28, 2015
• Results First Posted: July 3, 2015

Record last verified: 2015-07

Locations

US (1)