N/A
Completed N=7
Rollover Study to Evaluate Histological Results of Radiofrequency Device Treatments on the Flanks
Skin Laxity
Source: ClinicalTrials.gov NCT04881149 ↗
Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Number of Treatment Samples With Different Levels of Elastin When Compared to Baseline Samples From the Same Patient — 0 biopsy samples
Summary
The purpose of this study is to evaluate histological results of the treatments with the TempSure Firm handpiece on the flanks performed in the CYN20-FIRM-LIPO study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Samples With Different Levels of Elastin When Compared to Baseline Samples From the Same Patient |
— | — |
| PRIMARY Number of Treatment Samples With Different Levels of Dermis Collagen When Compared to Baseline Samples Taken From the Same Patient |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subject has completed their participation in the CYN20-FIRM-LIPO study.
Exclusion Criteria
- The subject has not had any other treatment in the treatment area after their involvement in the CYN20-FIRM-LIPO study.
- The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
Data sourced from ClinicalTrials.gov (NCT04881149). 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. Informational only — not medical advice.