Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
No-Treatment Control, HAC 20L · 1 trial · 1 indication
The NLFSS is a 5-point photonumeric scale used by the EI to assess the severity of each NFL where 0 = None and 4 = Extreme. A responder is defined as a participant who shows at least 1-point improvement on the NLFSS from baseline on both sides.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this device
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Treatment Group | EXPERIMENTAL | Participants will receive subdermal injection of HAC20L to the nasolabial folds on Day 1 followed by an optional touch-up treatment on Day 30 if applicable. Participants will then be eligible to receive optional repeat treatment at Month 12 if applicable. |
| Cohort 1: Control Group | OTHER | Participants will not receive treatment for 6 months and then will be offered an optional delayed treatment of HAC 20L after completion of of Month 6 visit with an optional touch-up treatment offered 30 days after delayed treatment. |
| Cohort 2: Treatment Group | EXPERIMENTAL | Participants will receive subdermal injection of HAC20L to the nasolabial folds on Day 1 followed by an optional touch-up treatment on Day 30 if applicable. Participants will then be eligible to receive optional repeat treatment at Month 12 if applicable. |
| Cohort 2: Control Group | OTHER | Participants will not receive treatment for 6 months and then will be offered an optional delayed treatment of HAC 20L after completion of of Month 6 visit with an optional touch-up treatment offered 30 days after delayed treatment. |
| Name | Type | Description |
|---|---|---|
| No-Treatment Control | OTHER | Participants will not receive treatment for 6 months and then will be offered an optional delayed treatment of HAC 20L after completion of of Month 6 visit with an optional touch-up treatment offered 30 days after delayed treatment. |
| HAC 20L | DEVICE | Subdermal Injections |
Inclusion Criteria: * Has moderate or severe NLFs (NLFSS score 2 or 3) on each NLF based on EI's live assessment (both NLFs must qualify and need to have the same score). * General good health, in the opinion of the TI, and no known current COVID 19 disease or previous COVID-19 disease-related symp...
No-Treatment Control, HAC 20L is an investigational treatment being studied for the correction of nasolabial folds, the creases that run from the sides of the nose to the corners of the mouth. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
No-Treatment Control, HAC 20L is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the safety and effectiveness of this treatment for nasolabial folds.
No-Treatment Control, HAC 20L is in Phase 2 clinical development. It is an investigational product, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety and effectiveness for treating nasolabial folds.
No-Treatment Control, HAC 20L has one completed clinical trial, identified as NCT06018987. This Phase 2 study evaluated adverse events and effectiveness of HAC 20L injections in 61 adult participants with nasolabial folds. The trial was conducted in Germany and enrolled participants aged 18 years and older.
Yes, No-Treatment Control, HAC 20L is the same as HAC 20L. The name 'No-Treatment Control' refers to the control group in the clinical trial, while HAC 20L is the active treatment being investigated. In the trial NCT06018987, HAC 20L injections were studied for the treatment of nasolabial folds.