Trial reportJournal of cosmetic dermatology2025
Efficacy and Safety of CKDB-501A in Treating Moderate-To-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center Phase III Trial.
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 trial NCT05804656 (A Randomized, Double-blind, Active-controlled, Multi-center Phase 3 Trial to Investigate the Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines), which is not on this map. Cited by 2 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 Randomized, Double-blind, Active-controlled, Multi-center Phase 3 Trial to Investigate the Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines
Who cites it
2 citing papers in PubMed.
- Efficacy and Safety of CKDB-501A in Treating Moderate-To-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center Phase III Trial.Journal of cosmetic dermatology · 2025Trial
- Review
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
backgroundBotulinum toxin is a key treatment for dynamic wrinkles.
objectiveThis study evaluates CKDB-501A, a botulinum toxin completely free from animal-derived components including human-serum albumin, comparing its efficacy and safety to onabotulinumtoxinA (ONA) for the treatment of moderate-to-severe glabellar lines.
methodsIn this phase 3 trial, 300 subjects with moderate-to-severe glabellar lines were randomized to receive CKDB-501A or ONA. The primary efficacy endpoint was the investigator-assessed improvement rate for frowning at week 4, defined as a ≥ 2-point improvement from baseline on the 4-point Facial Wrinkle Scale (FWS). Secondary efficacy endpoints included photo-assessed improvement rates and subjects' overall assessment and satisfaction. Safety was evaluated by the monitoring of adverse events (AEs) and neutralizing antibodies formation.
resultsAt week 4, 80.69% of the CKDB-501A group achieved a ≥ 2-point improvement in FWS score versus 70.83% for ONA, confirming non-inferiority (95% CI: 0.09-19.55, p = 0.0491). Secondary endpoints showed no significant differences between groups, with sustained efficacy up to 16 weeks. Approximately 70% maintained at least a 1-point improvement. Photo-assessed and subjects' overall improvement and satisfaction rates were consistent with primary findings. Both treatments had comparable safety profiles, with no AEs related to the local and distant spread of toxin, hypersensitivity reactions, or neutralizing antibodies formation.
conclusionCKDB-501A is a safe and effective alternative to existing botulinum toxin products for treating moderate-to-severe glabellar lines, offering benefits of improved biocompatibility and reduced risk of allergic reactions. CLINICALTRIALS: gov: NCT05804656.
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Registered trials
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