NCT02007434

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

Completed Phase 3 Results posted Last updated 6 July 2015

What this trial tests

Phase 3 trial testing Deoxycholic Acid Injection in Moderate or Severe Submental Fullness in 84 participants. Completed in 1 June 2014.

Timeline

1 December 2013

Primary endpoint
1 June 2014

1 June 2014

Quick facts

Lead sponsor	Kythera Biopharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	84
Start date	1 December 2013
Primary completion	1 June 2014
Estimated completion	1 June 2014
Sites	1 location across United States

Drugs / interventions tested

• Deoxycholic Acid Injection — full drug profile →
• Placebo
• Cold Compress
• Lidocaine / Epinephrine — full drug profile →
• Loratadine (loratadine) — full drug profile →
• Ibuprofen (ibuprofen) — full drug profile →
• Compression Chin Strap

Conditions studied

• Moderate or Severe Submental Fullness — all drugs for Moderate or Severe Submental Fullness →

Sponsor

Kythera Biopharmaceuticals — full company profile →

Who can join

Adults 18 to 65, any sex, with Moderate or Severe Submental Fullness. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
• 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
• 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

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Management of Patient Experience With ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat.
   Dover JS, Kenkel JM, Carruthers A, Lizzul PF, et al · · 2016 · cited 20× · PMID 27787269 · DOI 10.1097/dss.0000000000000908
2. Reduction of Submental Fat Continues Beyond 28 Days After ATX-101 Treatment: Results From a Post hoc Analysis.
   Dover JS, Shridharani SM, Bloom JD, Somogyi C, et al · · 2018 · cited 8× · PMID 29419542 · DOI 10.1097/dss.0000000000001484
3. MauiDerm for Dermatologists: Selected Abstracts from the 2018 Meeting
   · 2018