Trial reportJournal of cosmetic dermatology2025
Aesthetic Improvements Over Time: Long-Term Efficacy and Additional Outcomes of IncobotulinumtoxinA in the Simultaneous Treatment of Upper Facial Lines.
Trial report in Journal of cosmetic dermatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.
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.
A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)
A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)
Who cites it
3 citing papers in PubMed.
- Aesthetic Improvements Over Time: Long-Term Efficacy and Additional Outcomes of IncobotulinumtoxinA in the Simultaneous Treatment of Upper Facial Lines.Journal of cosmetic dermatology · 2025Trial
- Injectable Therapies for Orofacial Myofascial Pain: A Rapid Review of Randomized Controlled Trials.Journal of clinical medicine · 2026Review
- Efficacy and Safety of IncobotulinumtoxinA for the Simultaneous Treatment of Upper Facial Lines: A GRADE Assessed Systematic Review and Meta-analysis.Aesthetic surgery journal. Open forum · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
objectivesTwo Phase III randomized controlled trials were conducted in the US (ULTRA I) and Germany (ULTRA II) to investigate the efficacy of incobotulinumtoxinA for simultaneous treatment of upper facial lines (UFLs: glabellar frown lines [GFLs], horizontal forehead lines [HFLs] and lateral canthal lines [LCLs]). PATIENTS/
methodsHealthy adults with moderate to severe GFLs, HFLs, and symmetrical LCLs were enrolled. Participants were randomized 2:1:1 to three groups: placebo, UFLs, and GFLs & HFLs (ULTRA I) or LCLs (ULTRA II). All participants received up to 64 units of incobotulinumtoxinA in the main period (MP) and were eligible for two additional treatment cycles in the open-label extensions (OLEX). Endpoints included participant- and investigator-assessed Global Aesthetic Improvement Scale (pGAIS and iGAIS, respectively; any improvement defined as ≥ +1 score versus baseline) and the percentage of GFL, HFL, and LCL responders, defined as ≥ 1-grade improvement in Merz Aesthetics Scale (MAS) score versus baseline at maximum contraction.
resultsFor pGAIS at Day 30, the proportion of participants with any improvement was very high (> 97%) across all three treatment cycles. iGAIS results were similar and slightly higher than pGAIS results. In the MP, investigator and participant MAS assessments were similar, with > 78% of participants showing a positive treatment response for UFLs up to Day 90; responses in the placebo groups remained low at all time points (< 13%). MAS results in the OLEX were consistent with the MP.
conclusionsAdditional endpoints, including pGAIS, iGAIS, and MAS scores, corroborate prior ULTRAI/II findings and demonstrate the efficacy of incobotulinumtoxinA for simultaneous treatment of UFLs.
trial registrationULTRA I: NCT04594213; ULTRA II: NCT04622254.
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Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.