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APPROVEDReviewed and approved by the Chamgap Editorial Team (2026-08-02). The draft was written by AI, the existence of all 3 cited sources was verified at the original page, and the verdict passed blind grading and adversarial audit. Methodology v0.6.
Verdict No. 1945 · Search date 2026-08-02 · Methodology v0.6

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 · 58 · 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 58 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.
Gap Measurement · Verdict 1945 · C 58
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 (58)

Large consistent placebo-controlled responses with ATX-101 evidence confined to manufacturer-sponsored programs give C with 58 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

Scoring profile behind this grade
EndpointPPatient-reported treatment goal - the symptom is the goal
ReplicationR1Single confirmatory trial
IndependenceI0Evidence comes only from manufacturer studies
Effect sizeE+Meets the clinically important threshold

The scoring table and the verdict agree (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 — Codex and Claude

This verdict was drafted by Codex through literature review and source-existence checks, cross-checked through blind grading and adversarial audit, and settled by reapplying the methodology boundary rules. Cases with split grades were resolved through rejudgment.
03

Evidence Table

StudyDesignSampleFundingEndpointResultWeight
Study 1Multicenter double-blind placebo-controlled phase 3 randomized trial250Sponsored 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
Study 2Systematic review and meta-analysis of placebo-controlled randomized trials1,837Independent 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
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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
Draft and rewrite: Codex (AI) · Verification: Codex blind grading and adversarial audit · Final adjudication: Claude
Reviewed and approved: Chamgap Editorial Team · Approval 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·58. 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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