Dose‐Finding, Safety, and Tolerability Study of Botulinum Toxin Type B for the Treatment of Hyperfunctional Glabellar Lines
Bibliographic record
Abstract
BACKGROUND: Previous open-label studies have demonstrated that botulinum toxin type B (BTX-B, Myobloc, Solstice Neurosciences) in doses of up to 3,000 U is safe and effective in the treatment of glabellar wrinkles. OBJECTIVE: This double-blind, randomized, placebo-controlled, sequential-dose-escalation study evaluated the safety and tolerability of seven BTX-B doses ranging from 250 to 3,000 U in the treatment of subjects with hyperfunctional glabellar lines. METHODS: Participants received a single intramuscular treatment of either BTX-B or placebo at five facial sites with a 12-week follow-up period. Primary efficacy outcome measure was the Investigator Global Scale score of subject's glabellar lines at rest and at full frown. Safety was evaluated primarily on the occurrence of adverse events (AEs). RESULTS: The investigator scores demonstrated a statistically significant increasing dose-response trend in the percentage of subjects with no lines or mild lines at rest from Weeks 1 to 12 (p=.0420) and at full frown from Weeks 1 to 8 (p<.0001). Fifty-one subjects (36.7%) experienced AEs; the most common AE was headache not otherwise specified, experienced by 19 subjects (13.7%). CONCLUSIONS: BTX-B at doses up to 3,000 U was safe and well tolerated in the treatment of hyperfunctional glabellar lines. Treatment with BTX-B reduced hyperfunctional glabellar lines in subjects, and the duration of action appeared to be related to the dose administered. Further studies using higher doses of BTX-B for treatment of glabellar wrinkles are planned.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".