Trial reportAesthetic plastic surgery2025
Effectiveness and Safety of STYLAGE
Trial report in Aesthetic plastic surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundProminent nasolabial folds (NLFs) are a typical manifestation of aging. Hyaluronic acid (HA)-based injectable fillers are commonly used for correction. The NICE Study primarily evaluated non-inferiority of STYLAGE
methodsThis was a double-blind, randomized, controlled, within-subject (split-face) study with 12 months follow-up. The primary endpoint was mean change in Wrinkle Severity Rating Scale (WSRS) score from baseline to 6 months after treatment initiation. Secondary endpoints included differences in NLF depth using interference fringe projection profilometry, Global Aesthetic Improvement Scale (GAIS), subject satisfaction, pain during injection, and tolerance.
resultsOf the 50 subjects randomized, 47 were analyzed. In the primary endpoint analysis, non-inferiority of STYL-L to JUV-3 was demonstrated as the upper limit of the 95% confidence interval (CI) was inferior to 0.5 (difference [95% CI] in WSRS change from baseline at 6 months was 0.11 [-0.07; 0.28]). NLF average depth was similarly reduced with STYL-L and JUV-3 at 1 month (adjusted mean [standard error] decrease of 0.049 [0.003] mm and 0.049 [0.004] mm, respectively), and generally maintained. Both evaluators and subjects considered NLFs improved, with all or almost all subjects classed as GAIS responders with both devices throughout the study. Overall subject satisfaction was high. Pain ratings were low. Both devices were well tolerated.
conclusionsNon-inferiority of STYL-L versus JUV-3 in improving NLFs was demonstrated. Results up to 12 months suggest comparable effectiveness and safety profiles. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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