Clinical trial · Interventional
Patient Experience Study of Deoxycholic Acid Injection
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Moderate or Severe Submental Fullness | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cold Compress | Other | — | UNRESOLVED |
| Compression Chin Strap | Other | — | UNRESOLVED |
| Deoxycholic Acid Injection | Drug | — | UNRESOLVED |
| Ibuprofen | Drug | Ibuprofen | ALIAS |
| Lidocaine / Epinephrine | Drug | — | UNRESOLVED |
| Loratadine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Paradigm 1 / Deoxycholic Acid Injection
- description
- 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.
- interventionNames
- Drug: Deoxycholic Acid Injection
- Other: Cold Compress
- type
- PLACEBO_COMPARATOR
- label
- Paradigm 1/ Placebo
- description
- 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.
- interventionNames
- Drug: Placebo
- Other: Cold Compress
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDDover 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