Jeuveau Treatment of Glabellar Lines Using OLD Versus COLD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-16

Study Completion Date

2023-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a blinded, randomized study in the US to compare the duration response of two different concentrations of Jeuveau in healthy female subjects with moderate to severe dynamic glabellar lines on maximum frown.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines

NCT05320393

Glabellar Frown Lines

COMPLETED PHASE2

Xeomin Treatment of Glabellar Lines Using OLD Versus COLD

NCT05305768

Glabellar Frown Lines

UNKNOWN EARLY_PHASE1

Duration of Botox Using OLD Versus COLD for Treatment of Glabellar Lines

NCT05083286

Glabellar Frown Lines

UNKNOWN EARLY_PHASE1

Non Interventional Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines

NCT05481931

Glabellar Frown Lines

ACTIVE_NOT_RECRUITING

Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines

NCT02236312

Glabellar Frown Lines

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study involves a blinded, randomized, parallel-group design. The aim of this study is to evaluate the duration response of Jeuveau in subjects with moderate to severe dynamic glabellar lines at the approved on-label dose of 20 U, however comparing the use of highly Concentrated On Label Dose (COLD) to the On Label Dose and concentration (OLD). The COLD concentration is defined as 4 Units per 0.02 mL and the OLD concentration is defined as 4 Units per 0.1 mL.

The total Jeuveau dose will be 20U divided into 5 injections for both study groups. However, the injection volume will differ for the two study groups, such that the OLD (4 U per 0.1 mL) group will receive a total of 0.5 mL and the COLD (4 U per 0.02 mL) group will receive a total of 0.1mL.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glabellar Frown Lines

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OLD (4 U per 0.1 mL)

The total Jeuveau dose will be 20U divided into 5 injections. Each subject will receive a total of 0.5 mL of Jeuveau during the treatment.

Group Type ACTIVE_COMPARATOR

prabotulinumtoxinA

Intervention Type DRUG

Injection of glabellar rhytids

COLD (4 U per 0.02 mL group)

The total Jeuveau dose will be 20U divided into 5 injections. Each injection will receive a total of 0.1 mL of Jeuveau during the treatment.

Group Type ACTIVE_COMPARATOR

prabotulinumtoxinA

Intervention Type DRUG

Injection of glabellar rhytids

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

prabotulinumtoxinA

Injection of glabellar rhytids

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Jeuveau

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* At least 18 years of age at the time of signing the informed consent.
* Overtly healthy as determined by medical evaluation (includes: medical history, physical examination, and vital signs).
* Subjects have moderate or severe dynamic glabellar lines on maximum frown as assessed with the Evolus GLS with photonumeric guide.
* Female sex.
* Female subjects willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. A female subject is eligible to participate if she is not pregnant (has a negative urine pregnancy result at Day 1 prior to treatment), is not breastfeeding, and at least one of the following conditions applies: 1)Not a female of childbearing potential OR 2) A female of childbearing potential who agrees to follow the contraceptive guidance in Appendix 4 during the study.
* Capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Written informed consent from the subject has been obtained prior to any study-related procedures.
* Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information)
* Able, as assessed by the blinded evaluating investigator, and willing to follow study instructions and likely to complete all required study visits.

Exclusion Criteria

* Brow or eyelid ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen upper facial rhytides, even by physically spreading them apart.
* Facial asymmetry including, in the opinion of the investigator, significant asymmetry with active contraction or at rest of the frontalis muscle.
* Medical condition that may increase the subject's risk of exposure to botulinum toxin, including diagnosed myasthenia gravis, Lambert-Eaton Syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
* Profound atrophy/excessive weakness of muscles in target areas of injection.
* History of facial nerve palsy.
* Infection at the injection site or systemic infection.
* Presence of inflammation at the proposed injection site.
* Previous cosmetic surgery to the upper face (eg, periorbital surgery, brow lift, eyelid or eyebrow surgery), tissue grafting, or tissue augmentation with silicone or fat or other permanent fillers, or planning a facial cosmetic procedure during the study period.
* Subjects have been treated in the upper face (forehead lines, glabellar lines, crow's feet lines) within 1 year prior to the Baseline/Day 1 Visit with botulinum toxin therapy of any serotype.
* Noncompliance with the proper washout periods for prohibited medications/procedures.
* Subjects on topical retinoid therapy and/or topical hormone cream applied to the face, who have not been on a consistent dose regimen for at least 6 months prior to enrollment and who are unable to maintain a consistent dose regimen during the study.
* Oral retinoid therapy within 1 year prior to study enrollment.
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
* Females who are pregnant, breastfeeding, or planning a pregnancy during the study
* Females of childbearing potential not using a reliable means of contraception (see Appendix 4 for definition and acceptable methods of contraception).
* Known allergy or sensitivity to the study treatment or its components.
* Known immunization or hypersensitivity to any botulinum toxin serotype.
* Prior exposure to or anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment).
* Evidence of recent alcohol or drug abuse.
* The subject has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes