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Nasolabial FoldsPhase 2/3NCT06018987

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

A Phase 2/3 study testing HAC 20L in people with Nasolabial Folds, run by AbbVie at 10 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nasolabial Folds
What is being tested?
HAC 20L
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
10 sitesGermany
Study dates
5 Sep 2023to 3 Feb 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • CRS Clinical Research Services Berlin GmbH /ID# 240390

    Berlin, 13627

  • Dermatologische Gemeinschaftspraxis Mahlow /ID# 232366

    Blankenfelde-Mahlow, Brandenburg, 15831

  • Hautzentrum Koeln /ID# 231406

    Cologne, North Rhine-Westphalia, 50996

  • Privatpraxis Dr. Hilton & Partner /ID# 231401

    Düsseldorf, North Rhine-Westphalia, 40212

  • Dermatologie am Luegplatz /ID# 233788

    Düsseldorf, 40545

  • Universitaet Hamburg /ID# 231641

    Hamburg, 20146

  • Noahklinik GmbH /ID# 231917

    Kassel, 34117

  • Privatpraxis fuer Dermatologie und Aesthetik /ID# 231402

    München, 80539

  • Hautok and Hautok-cosmetics /ID# 254549

    Munich, Bavaria, 80333

  • MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 231403

    Oberursel, Hesse, 61440

Other trials in Germany

About this study

Official title: A Multicenter, Evaluator-blinded, Randomized, Delayed Treatment Control Group Study of the Safety and Effectiveness of HAC 20L for the Correction of Moderate to Severe Nasolabial Folds

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.

Read more

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.

Being tested
No-Treatment Control, HAC 20L
Keywords
HAC 20L, AGN-8010, Nasolabial Folds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No-Treatment ControlOther

    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 20LDevice

    Subdermal Injections

Study groups in NCT06018987
Study groupRoleWhat they receive
Cohort 1: Treatment GroupExperimentalParticipants 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.
Receives: Device: HAC 20L
Cohort 1: Control GroupOtherParticipants 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.
Receives: Other: No-Treatment Control
Cohort 2: Treatment GroupExperimentalParticipants 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.
Receives: Device: HAC 20L
Cohort 2: Control GroupOtherParticipants 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.
Receives: Other: No-Treatment Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    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.

    Measured: Month 6

  2. Number of Participants with Adverse Events (AEs)

    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

    Measured: Month 16

Secondary outcomes (3)

  1. Change from Baseline on the Overall Score of FACE-Q-Appraisal of Lines: Nasolabial Folds Questionnaire

    The FACE Q-Appraisal of lines: Nasolabial Folds consists of 5 questions to assess how much the participants has been bothered by various aspects of NLFs in the past week where 1 = not at all and 4 = extremely.

    Measured: Baseline to Month 6

  2. Percentage of Participants Achieving Responder Status Based on Evaluating Investigator's Assessment of Global Aesthetic Improvement on the NLF Area using the Global Aesthetic Improvement Scale (GAIS)

    The GAIS will assess global aesthetic improvement of the NLF area by comparing the frontal and side view photographs taken at baseline where -2 = Much Worse and 2 = Much Improved. A responder is defined as achieving "improved" or "much improved".

    Measured: Month 6

  3. Percentage of Participants Achieving Responder Status Based on Participant's Assessment of Global Aesthetic Improvement in the NLF Area Using the GAIS

    The GAIS will assess global aesthetic improvement of the NLF area by comparing the frontal and side view photographs taken at baseline where -2 = Much Worse and 2 = Much Improved. A responder is defined as achieving "improved" or "much improved".

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2023
  2. Study start5 Sep 2023
  3. Primary completion3 Feb 2025
  4. Study completion3 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06018987
Sponsor's protocol ID
M21-833
Status last verified
Feb 2025
First submitted
25 Aug 2023
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing HAC 20L in people with Nasolabial Folds, run by AbbVie at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06018987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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