Cosmetic TechniquesJBDXNCT05167864
Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area
A study testing Onabotulinumtoxina for Injection, Abobotulinumtoxina for Injection and IncobotulinumtoxinA for Injection in people with Cosmetic Techniques, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of the study is to use 3D imaging to evaluate the effects of four FDA approved neuromodulators on facial lines, wrinkles and animation. Participation is available to women who have never had a cosmetic procedure above the malar region nor a treatment with a neuromodulator within 12 months. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Cosmetic Techniques
- What is being tested?
- Onabotulinumtoxina for Injection, Abobotulinumtoxina for Injection and IncobotulinumtoxinA for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- 30-65 years of age
- Interested in glabellar injections to reduce rhytids and facial strain
- Participants must sign the informed consent form
Who cannot join
- Females under 30 or above 65 years of age
- Males
- Those who have received glabellar injections for rhytids <12 months
- Underwent cosmetic surgical procedure above the malar region
- Those with a condition that affects facial expression, such as prior stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Prospective Evaluation of Four Injectable Neuromodulators in the Glabella Area
The purpose of the study is to use 3D imaging to evaluate the effects of four FDA approved neuromodulators on facial lines, wrinkles and animation. Participation is available to women who have never had a cosmetic procedure above the malar region nor a treatment with a neuromodulator within 12 months. All subjects will undergo 3D imaging using the VECTRA M3 (Canfield Scientific, Inc, Fairfield, NJ) prior to treatment with a neuromodulator in order to determine their baseline dimensions. Imaging will be repeated post injection to determine change over time.
Read the detailed description
This study is a randomized controlled trial in which patients will be randomly assigned into one of four groups: those receiving onabotulinumtoxinA (Botox, Allergan, Irvine, California), abobotulinumtoxinA (Dysport, Ispen Biopharmacueticals Inc.Cambridge, MA), incobotulinumtoxinA (Xeomin, Raleigh, NC) or prabotulinumtoxinA (Jeuveau, Evolus, Newport Beach, California). Each patient will receive FDA approved dosages in which they are assigned in to treat rhytids within the glabella, as per FDA approved indications. All injections will be performed by a blinded single trained physician according to a preset injection plan per FDA approved administration guidelines. Prior to injection patients will be imaged with 3-dimensional photogrammetry. All pre-procedure images will be evaluated for absolute strain performing two types of facial animation: 1) relaxed, and 2) frowning. Subjects will return Day 3, 30, 90, and 180, post intervention for re-imaging with the same expressions. Strain will be calculated using the same metrics.
- Conditions
- Cosmetic Techniques
- Being tested
- Onabotulinumtoxina for Injection, Abobotulinumtoxina for Injection, IncobotulinumtoxinA for Injection, PrabotulinumtoxinA for Injection
- Keywords
- minimally invasive procedures, neurotoxins, cosmetic, Botox, eyebrow area, glabella, Dysport, Jeuveau, Xeomin, forehead, cosmetic injections, facial rejuvenation, wrinkle reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onabotulinumtoxina for InjectionDrug
Also called Botox
cosmetic injection into the glabella area (eyebrow area)
Abobotulinumtoxina for InjectionDrug
Also called Dysport
cosmetic injection into the glabella area (eyebrow area)
IncobotulinumtoxinA for InjectionDrug
Also called Xeomin
cosmetic injection into the glabella area (eyebrow area)
PrabotulinumtoxinA for InjectionDrug
Also called Jeuveau
cosmetic injection into the glabella area (eyebrow area)
| Study group | Role | What they receive |
|---|---|---|
| OnabotulinumtoxinA | Active comparator | Botox Receives: Drug: Onabotulinumtoxina for Injection |
| AbobotulinumtoxinA | Active comparator | Dysport Receives: Drug: Abobotulinumtoxina for Injection |
| IncobotulinumtoxinA | Active comparator | Xeomin Receives: Drug: IncobotulinumtoxinA for Injection |
| PrabotulinumtoxinA | Active comparator | Jeuveau Receives: Drug: PrabotulinumtoxinA for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Change in Dynamic Strain in the Glabella Area After Injection Over Time
The change in dynamic strain of the glabella area after injection using 3D facial imaging measurements over time At each visit two images were captured, one neutral and one dynamic. The neutral face was relaxed and served as a reference while the dynamic face was the subject's expression when asked to furrow their glabella by frowning (compressed face). A decrease in strain indicates reduced compression, as there is a smaller difference between the neutral face and the dynamic, or compressed, face.
Measured: day 3, day 30, day 90, day 180
Secondary outcomes (1)
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
Correlation of patient reported satisfaction (FACE-Q) to the degree of dynamic strain overtime. Correlation is determined at each time point post intervention Day 3, Day 30, Day 90 and Day 180.
Measured: baseline, day 3, day 30, day 90, day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start4 Mar 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cosmetic TechniquesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial in which patients will be randomly assigned into one of four groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167864
- Sponsor's protocol ID
- 849045
- Acronym
- JBDX
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2021
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lemdani MS, Honig SE, Habarth-Morales TE, Davis HD, Niu EF, Ewing JN, Broach RB, Serletti JM, Percec I. Comparison of Botulinum Toxin A Formulations for Glabellar Strain Treatment in Women: A Double-Blind Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 1;161(7):723-730. doi: 10.1001/jamadermatol.2025.1335.
PubMed 40434770
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Evaluation of Four Injectable Neuromodulators in the Glabella Area
- ClinicalTrials.gov ID
- NCT05167864
- Acronym / sponsor ID
- JBDX / 849045
- Conditions
- Cosmetic Techniques
- Keywords
- minimally invasive procedures, neurotoxins, cosmetic, Botox, eyebrow area, glabella, Dysport, Jeuveau
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to use 3D imaging to evaluate the effects of four FDA approved neuromodulators on facial lines, wrinkles and animation. Participation is available to women who have never had a cosmetic procedure above the malar region nor a treatment with a neuromodulator within 12 months. All subjects will undergo 3D imaging using the VECTRA M3 (Canfield Scientific, Inc, Fairfield, NJ) prior to treatment with a neuromodulator in order to determine their baseline dimensions. Imaging will be repeated post injection to determine change over time.
Detailed description
This study is a randomized controlled trial in which patients will be randomly assigned into one of four groups: those receiving onabotulinumtoxinA (Botox, Allergan, Irvine, California), abobotulinumtoxinA (Dysport, Ispen Biopharmacueticals Inc.Cambridge, MA), incobotulinumtoxinA (Xeomin, Raleigh, NC) or prabotulinumtoxinA (Jeuveau, Evolus, Newport Beach, California). Each patient will receive FDA approved dosages in which they are assigned in to treat rhytids within the glabella, as per FDA approved indications. All injections will be performed by a blinded single trained physician according to a preset injection plan per FDA approved administration guidelines. Prior to injection patients will be imaged with 3-dimensional photogrammetry. All pre-procedure images will be evaluated for absolute strain performing two types of facial animation: 1) relaxed, and 2) frowning. Subjects will return Day 3, 30, 90, and 180, post intervention for re-imaging with the same expressions. Strain will be calculated using the same metrics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- randomized controlled trial in which patients will be randomly assigned into one of four groups
| Arm | Type | Receives |
|---|---|---|
| OnabotulinumtoxinA | Active comparator | Drug: Onabotulinumtoxina for InjectionBotox |
| AbobotulinumtoxinA | Active comparator | Drug: Abobotulinumtoxina for InjectionDysport |
| IncobotulinumtoxinA | Active comparator | Drug: IncobotulinumtoxinA for InjectionXeomin |
| PrabotulinumtoxinA | Active comparator | Drug: PrabotulinumtoxinA for InjectionJeuveau |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- 30-65 years of age
- Interested in glabellar injections to reduce rhytids and facial strain
- Participants must sign the informed consent form
Key exclusion criteria (5 listed)
- Females under 30 or above 65 years of age
- Males
- Those who have received glabellar injections for rhytids <12 months
- Underwent cosmetic surgical procedure above the malar region
- Those with a condition that affects facial expression, such as prior stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Onabotulinumtoxina for InjectionAlso: Botoxcosmetic injection into the glabella area (eyebrow area) | Drug | OnabotulinumtoxinA |
| Abobotulinumtoxina for InjectionAlso: Dysportcosmetic injection into the glabella area (eyebrow area) | Drug | AbobotulinumtoxinA |
| IncobotulinumtoxinA for InjectionAlso: Xeomincosmetic injection into the glabella area (eyebrow area) | Drug | IncobotulinumtoxinA |
| PrabotulinumtoxinA for InjectionAlso: Jeuveaucosmetic injection into the glabella area (eyebrow area) | Drug | PrabotulinumtoxinA |
Primary outcome
the Change in Dynamic Strain in the Glabella Area After Injection Over Time
Time frame: day 3, day 30, day 90, day 180
The change in dynamic strain of the glabella area after injection using 3D facial imaging measurements over time At each visit two images were captured, one neutral and one dynamic. The neutral face was relaxed and served as a reference while the dynamic face was the subject's expression when asked to furrow their glabella by frowning (compressed face). A decrease in strain indicates reduced compression, as there is a smaller difference between the neutral face and the dynamic, or compressed, face.
1 secondary outcome
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
Time frame: baseline, day 3, day 30, day 90, day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40434770Lemdani MS, Honig SE, Habarth-Morales TE, Davis HD, Niu EF, Ewing JN, Broach RB, Serletti JM, Percec I. Comparison of Botulinum Toxin A Formulations for Glabellar Strain Treatment in Women: A Double-Blind Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 1;161(7):723-730. doi: 10.1001/jamadermatol.2025.1335.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Onabotulinumtoxina for Injection, Abobotulinumtoxina for Injection and IncobotulinumtoxinA for Injection in people with Cosmetic Techniques, run by University of Pennsylvania at 1 site in United States.
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 4 inclusion and 5 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 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
the Change in Dynamic Strain in the Glabella Area After Injection Over Time (time frame: day 3, day 30, day 90, day 180). 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 NCT05167864, which also lists 1 linked publication.
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 17 Jan 2025.