CHAMGAP
VERIFIEDPassed the Codex final verification and publication gate. Evidence-verification cutoff: 2026-08-02. AI was used for research and drafting; the existence of all 3 cited sources was verified at the original page, followed by blind grading, adversarial audit, and build validation. Methodology v1.0.
Verdict No. 1945 · Search date 2026-08-02 · Methodology v1.0

Deoxycholic acid injection,
does it really help with Visible reduction of moderate or severe submental fat in adults?

30-Second Summary
C
Evidence Grade C · 54 · Safety caution
Submental-fat rating improvement replicated, but independently funded and active-comparator evidence is lacking
Injection-site swelling, bruising, pain, and numbness are common. Pooled dysphagia was 10/513 (2.0%) versus 1/506 (about 0.2%), and marginal mandibular nerve injury or paresis was 20/513 (4.0%) versus 1/506 (about 0.2%); REFINE-1 alone reported about 1.6% and 4.3%, respectively. Facial nerve effects at roughly one in 20 treated participants matter in a cosmetic procedure. Safety is not a grading basis.
What the
research shows
The grade is C. REFINE-1 included all 506 randomized participants in modified intention-to-treat analysis. Its coprimary composite responses succeeded: at least one-grade improvement by both clinician and patient occurred in 70.0% versus 18.6%, and at least two grades in 13.4% versus 0%, both P<0.001. European and North American trials pointed the same way, but verified ATX-101 placebo trials came only from Kythera or Bayer/Kythera programs, giving C with 54 points.
What the
ads claim
Adipocyte disruption is not a guarantee of a desired jawline. Trials established rating-scale improvement and better satisfaction in moderate or severe submental fat, but only 13.4% achieved the larger two-grade composite response in REFINE-1.
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Useful facts when choosing a product

  • Response is binary, but no validated between-group threshold for the CR-SMFRS rating scale was confirmed.
  • REFINE-1 and REFINE-2 were both supported by Kythera.
  • Safety information was not used as an efficacy-grading basis.
ID

Chamgap Semantic Classification Code

Candidate index · review held

UNK.deoxycholic-acid-injection.UNK.visible-reduction-of-moderate-or-severe-submental-fat.reduce.placebo

Unknown > Deoxycholic acid injection > Unknown > Visible reduction of moderate or severe submental fat > Reduction claim > Placebo

An automated migration candidate, not an issued permanent code; exact claim scope remains under review. This machine-generated migration candidate helps retrieval but is not a permanent assignment. The original verdict ID and URL remain authoritative.

Download semantic index (JSON) · Codebook v1

Gap Measurement · Verdict 1945 · C 54
What advertising claims
What independent, higher-quality research supports
△ GAP
01

What the research actually shows

REFINE-1 included 506 participants (256/250): at-least-one-grade composite response was 70.0% versus 18.6%, a 51.4-point difference, and at least two grades was 13.4% versus 0%, a 13.4-point difference. REFINE-2 included 516 (258/258): at least one grade was 66.5% versus 22.2%, a 44.3-point difference and RR 2.98 (95% CI 2.31 to 3.85), and at least two grades was 18.7% versus 3.2%, a 15.5-point difference. Kythera supported both trials.

02

Why this is classified as C (54)

Large consistent placebo-controlled responses with ATX-101 evidence confined to manufacturer-sponsored programs give C with 54 points.

Counterpoint. Only 13.4% achieved the larger two-grade composite response, and independent pivotal and active-comparator trials are absent.

Rejudgment record. Cross-check applied — Both coprimary appearance responses succeeded by large margins, but the ATX-101 placebo-controlled evidence base is concentrated entirely in manufacturer-sponsored programs

Stored scoring profile
EndpointPSymptom or function itself is the target - including patient reports and performance tests
ReplicationR1Single confirmatory trial
IndependenceI0Evidence comes only from manufacturer studies
Effect sizeE+Meets the clinically important threshold

Stored derived and displayed grades match; this is not a current recalculation or validity check (C).

Sub-claim grades by effect

This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.

Effect (sub-claim)GradeBasis
At least one-grade clinician-patient composite improvementCREFINE-1 found 70.0% versus 18.6%, but independently funded trials are absent.
At least two-grade large composite improvementCThe 13.4% versus 0% result succeeded, but most treated participants did not reach this larger response.

Cross-check — AI research and Codex final gate

AI was used for research and drafting. Blind grading, adversarial audit, and the methodology boundary rules were then reapplied before Codex performed the final evidence, grade, copy, and build checks. If a grade cannot be narrowed, both evidence positions and their reasons are published.
03

Evidence Table

StudyDesignSampleFundingEndpointResultWeight
Jones et al. 2016 REFINE-1Multicenter double-blind placebo-controlled phase 3 randomized trial506 randomized and 506 in modified intention-to-treat analysis, 256 versus 250Sponsored by Kythera Biopharmaceuticals with multiple company-employee authorsCoprimary at-least-one-grade and at-least-two-grade clinician-patient composite responsesAt least one grade 70.0% versus 18.6%; at least two grades 13.4% versus 0%; both P<0.001Direct pivotal coprimary-outcome evidence
Inocêncio et al. 2023 systematic reviewSystematic review and meta-analysis of placebo-controlled randomized trialsFive RCTs and 1,837 participantsIndependent academic review; all five included trials company-sponsoredClinician and patient submental-fat ratings, satisfaction, and adverse eventsAll efficacy measures favored treatment, but every trial had industry sponsorship and author conflictsSynthesis confirming repeated effects and industry concentration
§

Receipt — 3 References

All 3 cited sources were verified for existence at the original page (as of 2026-08-02).

Jones DH, Carruthers J, Joseph JH, et al. REFINE-1, a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial with ATX-101. Dermatol Surg. 2016;42:38-49. PMID: 26673433. DOI: 10.1097/DSS.0000000000000578.
checked
Inocêncio GSG, Meneses-Santos D, Costa MDMA, et al. Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction: a systematic review and meta-analysis of randomized clinical trials. Clinics. 2023;78:100220. PMID: 37806137. DOI: 10.1016/j.clinsp.2023.100220.
checked
Humphrey S, Sykes J, Kantor J, et al. ATX-101 for reduction of submental fat: a phase III randomized controlled trial. J Am Acad Dermatol. 2016;75:788-797.e7. DOI: 10.1016/j.jaad.2016.04.028.
checked
Research and draft: AI used · Cross-check: blind grading and adversarial audit
Final verification and publication gate: Codex · Evidence date: 2026-08-02 · Corrections: none

Cite this verdict

Deoxycholic acid injection x double-chin reduction Evidence Grade C card
[Chamgap] Deoxycholic acid injection x double-chin reduction — Evidence Grade C·54. 3 cited sources checked. Source: https://chamgap.com/en/verdicts/weight/deoxycholic-acid-injection-submental-fat-reduction/ · CC BY 4.0

CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.

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