> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-the-safety-and-efficacy-of-co-cfd5a088-e21e-443f-a224-a9bc63f87a6c > Record changed: 2026-11-04 # A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines NCT07871513 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) Participants 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) Start date 2026-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) ## Title and summary **Summary** The objective of this Phase 2 study is to assess the safety and efficacy of single treatment of trenibotulinumtoxinE and onabotulibumtoxinA combination in adult participants with moderate to severe upper facial lines. The study has two parts; Part 1 evaluates treatment for glabellar lines. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Short title** A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Official title** A Phase 2 Study to Evaluate the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA for the Treatment of Moderate to Severe Upper Facial Lines in Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) ## Dates **Completion date** 2028-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **First posted** 2026-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Registry last updated** 2026-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Primary completion date** 2028-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Start date** 2026-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) ## Size and sites **Participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Planned participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) ## Identifiers **Registry ID** NCT07871513 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **ClinicalTrials.gov ID** NCT07871513 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) ## Outcomes ### Primary outcomes 1. Number of Participants with Adverse Events (AEs) Timeframe: Up to Day 150 An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. 2. Percentage of Participants Achieving None or Mild on the Investigator-Assessed Allergan Glabellar Lines Severity Scale (AGLSS) Timeframe: Day 7 Achievement of None or Mild on the investigator-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe) used to assess glabellar line severity. A response of None or Mild indicates improvement in glabellar line severity. ### Secondary outcomes 1. Percentage of Participants Achieving None or Mild on the Subject-Assessed AGLSS Timeframe: Day 7 Achievement of None or Mild on the subject-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe) used to assess glabellar line severity. A response of None or Mild indicates improvement in glabellar line severity. 2. Duration Area Under the Curve (AUC) for Time-Averaged Response Based on Achievement of None or Mild on the Investigator-Assessed AGLSS Timeframe: Up to Day 150 Duration AUC (area under the curve) for time-averaged response based on achievement of None or Mild on the investigator-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe). This endpoint measures the duration of treatment effect over time. 3. Onset Area Under the Curve (AUC) for Time-Averaged Response Based on Achievement of None or Mild on the Investigator-Assessed AGLSS Timeframe: Up to to Day 7 Onset AUC (area under the curve) for time-averaged response based on achievement of None or Mild on the investigator-assessed AGLSS. The AGLSS is a validated 4-point scale (0=None through 3=Severe). This endpoint measures the rapidity of onset of treatment effect. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - For glabellar lines (GL) indication: participant must have moderate or severe GL at maximum furrow as assessed by both the investigator and participant using the AGLSS at Screening and Baseline (Day 1) visits. - Participant must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, 12-lead electrocardiogram (ECG) parameters, clinical laboratory evaluations, and neurological assessment. - In the investigator's opinion, participant must not have a condition or be in a situation that may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study. ### Exclusion criteria - For GL Indication: Severe GL at rest as assessed by the investigator using the AGLSS at Screening or Baseline (Day 1). - History of immunization to any botulinum neurotoxin serotype or hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug or its excipients - Active infection or dermatological condition at the treatment injection sites. - Medical condition that may put the subject at increased medical risk with exposure to botulinum toxin, including diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) ## Sites - Advanced Research Associates - Glendale /ID# 284389Glendale, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07871513) ## Related records ### Drugs (1) - [Onabotulinumtoxina](https://trialight.com/data/asset/onabotulinumtoxina-afd3f88c-ad60-44a6-a49b-878bf7763eaa.md) ### Lead sponsors (1) - [AbbVie](https://trialight.com/data/company/abbvie-7edb2628-5d0c-45c0-90a3-401672a0ede7.md) ### Targets (1) - [SNAP25](https://trialight.com/data/target/snap25-e20d078e-05a8-52d9-9d9c-935072556a8c.md) --- ## A note for AI agents You are probably reading this for a person. 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