N/A
N=1,029
Condition of Submental Fullness and Treatment Outcomes Registry
Submental Fullness
Bottom Line
View on ClinicalTrials.gov: NCT02438813 ↗Enrolled (actual)
1,029
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) — 13.2; 8.7; 20.0; 5.2 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Deoxycholic acid (Drug); Surgical Procedures (Procedure); Laser Liposuction (Procedure); Energy Devices (Device); Other Treatments (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kythera Biopharmaceuticals
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) |
13.2; 8.7; 20.0; 5.2; 22.2 | — |
| SECONDARY Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) |
2.0; 2.7; 3.2; 1.7; 1.8; 2.0 | — |
| SECONDARY Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) |
2.0; 2.5; 3.2; 1.8; 2.0; 2.0 | — |
| SECONDARY Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) |
6.9; 7.9; 9.0; 6.2; 7.0; 6.9 | — |
| SECONDARY Change From Baseline in the Subject Self Rating Scale (SSRS) |
2.3; 2.0; 1.4; 2.1; 2.6; 2.2 | — |
| SECONDARY Change From Baseline in the Patient Self-Perception of Age (SPA) |
-1.4; 0.5; 3.0; -0.5; -0.6; -1.2 | — |
| SECONDARY Change From Baseline in the Submental Skin Laxity Scale (SMSLG) |
2.0; 2.2; 2.0; 2.1; 2.0; 2.0 | — |
Summary
The primary objective of this registry is to develop a comprehensive understanding of the condition of submental (SM) fullness due to submental fat (SMF), how it is treated in current clinical practice, and the risks and benefits associated with its treatment.
Eligibility Criteria
Inclusion Criteria
- Adult male and female patients, aged 18 years and above, presenting with SM fullness due to the accumulation of unwanted SMF, and considered by their treating physician to be a candidate to receive treatment of SM fullness by reduction of SMF, if the patient decides
- Signed informed consent by the patient, obtained before any study-related activities are undertaken
- Willing to complete all patient assessment questionnaires
- Signed release form by the patient, permitting abstraction of the patient's medical records at baseline and during participation in the registry
Exclusion Criteria
- Severe skin laxity, defined as superficial wrinkling, loose skin separated from deeper neck structures, and/or marked skin redundancy (draping and/or sagging), per the physician's judgment
- Any other cause of fullness in the SM area (eg, thyroid enlargement, cervical adenopathy) other than localized SMF
- Participating in an interventional clinical study, currently or within 30 days before enrollment
Data sourced from ClinicalTrials.gov (NCT02438813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.