CompletedPhase 2/3

A Study to Assess Adverse Events and Effectiveness of HAC 20L Injections in Adult Participants for the Treatment of Nasolabial Folds

Germany61 participantsStarted 2023-09-05

Plain-language summary

Nasolabial folds (NLF) are the two skin folds that run from each side of the nose to the corners of the mouth. Prominent NLFs distort the contour of the midface, giving a fatigued and aged appearance. Soft tissue fillers can be used to reduce the depth of NLFs and restore a more youthful appearance. The purpose of this study is to evaluate how safe and effective HAC 20L is in the correction of moderate to severe NLF in adult participants. HAC 20L is an investigational drug being developed for the treatment of NLF. There are 2 cohorts in this study. In each cohort participants are assigned to either the treatment group or no-treatment control group. There is a 1 in 3 chance that participants will be assigned to the no-treatment control group. Around 75 adult participants with moderate to severe NLF will be enrolled in the study at approximately 20 sites worldwide. Participants in the treatment group will receive an injection of HAC 20L to the NLF on Day 1 in Cohort 1 and Cohort 2 with the option of re-treatment after completion of Month 12 visit. The control group will receive no treatment but will be offered an optional HAC 20L treatment after 6 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be examined by completing effectiveness questionnaires by the subjects, evaluating investigator (EI) and central reviewers as well as monitoring safety assessments such as vital signs, blood tests, injection site responses and adverse events.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 symptoms within 30 days. Exclusion Criteria: * Atrophic skin in the facial area that makes it unsuitable for injection. * History of anaphylaxis or history or presence of multiple severe allergies, including allergy to antiseptic solution, lidocaine (or any amide-based anesthetics), HA products, human recombinant collagen, bovine or porcine collagen products, gram positive bacterial proteins (including Streptococcal protein) or to any of the excipients. * Prior fat injection or permanent implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face, or is planning to be implanted with any of these products at any time during the study. * Received semipermanent soft-tissue filler treatment (e.g., calcium hydroxyapatite, poly-L-lactic acid) in the face below the orbital rim within 24 months before enrollment, or is planning to be implanted with any of these products at any time during the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Achieving Responder Status Based on Evaluating Investigator's (EI's) Live Assessment of Nasolabial Folds (NLF) Severity using the Nasolabial Fold Severity Scale (NLFSS)

Timeframe: Month 6

Number of Participants with Adverse Events (AEs)

Timeframe: Month 16

Trial details

NCT IDNCT06018987

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-03

View on ClinicalTrials.gov More Nasolabial Folds trials