Trials / Completed
CompletedNCT03650218
Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds
A Prospective, Open Label, Dose-escalating, Multicenter Clinical Investigation to Evaluate the Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- Croma-Pharma GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a prospective, open label, dose-escalating, multicenter clinical investigation to evaluate the safety and effectiveness of THIODERM STRONG in the correction of nasolabial folds. The performance is assessed using the 5-point Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 12 compared to baseline.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | THIODERM STRONG | Soft tissue filler containing crosslinked hyaluronic acid and Na-hyaluronate, supplemented with lidocaine hydrochloride as ancillary substance. |
Timeline
- Start date
- 2018-07-10
- Primary completion
- 2019-12-23
- Completion
- 2019-12-23
- First posted
- 2018-08-28
- Last updated
- 2024-12-09
Locations
2 sites across 1 country: Austria
Source: ClinicalTrials.gov record NCT03650218. Inclusion in this directory is not an endorsement.