N/A
Completed N=62
Restylane Defyne in a Stepwise Treatment Approach
Lower Face Folds and Lines
Source: ClinicalTrials.gov NCT04520997 ↗
Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3 — 18; 12; 10; 8 Participants
Summary
This was a 12-week study to evaluate the effectiveness and safety of Restylane Defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3 |
18; 12; 10; 8; 3; 9 | — |
| PRIMARY Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6 |
56.7; 75.9; 36.7; 17.2; 6.7; 6.9 | — |
| PRIMARY Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9 |
76.7; 71.4; 20.0; 17.9; 3.3; 10.7 | — |
| SECONDARY Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator |
90.3; 89.7; 9.7; 10.3; 90.0; 89.7 | — |
| SECONDARY Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) |
100; 93.1; 93.3; 93.1; 96.7; 89.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects willed to comply with the requirements of the study and provided a signed written informed consent
- Subjects willed to undergo augmentation and correction therapy in the studied indications
- Adult males or non-pregnant, non-breastfeeding females and women of non-child bearing potential over the age of 21
Exclusion Criteria
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
- Previous use of any permanent (non-biodegradable) treatment, lifting threads, permanent implants or autologous fat below the level of the horizontal line from the lower orbital rim
- Participation in any interventional clinical study within 30 days of screening
Data sourced from ClinicalTrials.gov (NCT04520997). 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.