Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT06946160
Brief Summary:
The aim of this study is to evaluate the efficacy and safety of AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) for correction of moderate to severe glabellar lines.
Hypothesis: AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) has acceptable efficacy and safety profile for correction of moderate to severe glabellar lines.
Primary Outcome: To verify the non-inferiority of the efficacy of AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) compared with AbobotulinumtoxinA (Dysport®, produced by Ipsen Co.) by percentage of responders at maximum frown at day 30 after treatment.
Researchers will compare the efficacy and safety profile of AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) with AbobotulinumtoxinA (Dysport®, produced by Ipsen Co.).
The study is designed as phase III, randomized, two armed, double-blind, parallel, active controlled, non-inferiority clinical trial.
Participants received a total dose of 40-60 units into 3 to 5 sites. After two weeks, a touch-up intervention could be done based on physician's assessment.
Detailed Description:
The study schedule includes Visit 0 (Screening), Visit 1 (Intervention, Day 0), and Follow-up Visits 2 (Day 14), 3 (Day 30), 4 (Day 90), and 5 (Day 120). At Visit 0, informed consent is obtained, and eligibility is assessed through initial evaluations and review of inclusion and exclusion criteria. At Visit 1, subjects are randomized (1:1) and receive the investigational treatment. Full-face photographs are obtained at Visit 1 (Before receiving the investigational treatment), and at Follow-up Visits 2, 3, 4, and 5, in both resting state and maximum frown. Efficacy is evaluated at Visits 3, 4, and 5. All adverse events are Recorded at all visits.
Study:
NCT06946160
Study Brief:
Protocol Section:
NCT06946160