Glabellar Frown LinesEarly Phase 1NCT04715048
Split-Face Study Comparing Botox and Jeuveau in Treating Glabellar Lines
A Early Phase 1 study testing PrabotulinumtoxinA and Onabotulinum toxin A in people with Glabellar Frown Lines, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy and side effects of Botox and Jeuveau for glabellar lines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- PrabotulinumtoxinA and Onabotulinum toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to Jun 2025
- Phase
- Early Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18
- Willingness to participate in the study and able to provide informed consent
Who cannot join
- Inability to follow up for study duration
- Prior neurotoxin injection in the last 4 months
- Prior surgery to the glabellar area
- Any planned aesthetic procedure to the glabellar area during the study period
- Cardiac Patients
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Roski Eye Institute
Los Angeles, California, 90033
About this study
Official title: Split-Face Study Comparing OnabotulinumtoxinA (Botox) and PrabotulinumtoxinA (Jeuveau) in Treating Glabellar Lines
The purpose of this study is to compare the efficacy and side effects of Botox and Jeuveau for glabellar lines.
Read the detailed description
After being informed about the study and potential risks, all patients given consent will receive Botox on one side of their face and Jueveau on the other. A random number generator will generate a list of 20 combinations of "1,2" or "2,1". "1,2" means the Botox (onabotulinumtoxin A) will be placed on the right side and "2,1" means that the Botox will be placed on the left. The other side will be injected with PrabotulinumtoxinA. 8-10 units will be injected into the designated glabella in 3 sites.
- Conditions
- Glabellar Frown Lines
- Being tested
- PrabotulinumtoxinA, Onabotulinum toxin A
- Keywords
- Botox, Jeuveau
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrabotulinumtoxinADrug
Also called Jeuveau
Glabellar line correction
Onabotulinum toxin ADrug
Also called Botox
Glabellar line correction
| Study group | Role | What they receive |
|---|---|---|
| Onabotulinumtoxin A | Experimental | 8-10 units of Botox will be injected in the glabellar lines in one side of the face in 3 different locations. This injection will happen once. Receives: Drug: Onabotulinum toxin A |
| Prabotulinumtoxin A | Experimental | 8-10 units of Jeuveau will be injected in the glabellar lines in the other side of the face in 3 different locations. This injection will happen once. Receives: Drug: PrabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement on a 10 point Frown Movement Scale at 3 weeks
10-point scale created by the investigator assessing movement of glabellar lines. Possible scores range from 0 (no movement) to 10 (movement).
Measured: 3 weeks
Secondary outcomes (6)
Days to onset of neurotoxin
# of days until neurotoxin begins decreasing movement on each side
Measured: Up to 2-4 days
Bruising from the injection on a scale of 1-10
Post injection bruising measured on a scale from 0 (no bruising) to 10 (most possible bruising) created by the investigator.
Measured: Up to 2-4 days
Pain from the injection on a scale of 1-10
Post injection pain will be measured on a scale from 0 (no pain) to 10 (most possible pain) created by the investigator.
Measured: Up to 2-4 days
Headache from the injection on a scale of 1-10
Post injection headache will be measured on a scale from 0 (no pain) to 10 (most possible pain) created by the investigator.
Measured: Up to 2-4 days
Movement on a 10 point Frown Movement Scale at 3 weeks
Patients grade their own movement of glabellar lines using a 10-point scale created by the investigator. Possible scores range from 0 (no movement) to 10 (movement).
Measured: 3 weeks
Change in glabellar lines on the Merz Score (0-4)
The Merz Score is a 5 point scale. The Merz Score will be used to grade glabellar lines at rest and frown at both baseline and the 3 week visit. Change will calculated from the 3 week visit compared to baseline.
Measured: At baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Jan 2021
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glabellar Frown LinesStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandy Zhang-Nunes, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715048
- Sponsor's protocol ID
- HS-19-00455
- Status last verified
- Dec 2023
- First submitted
- 10 Jan 2021
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rzany BJ, Ascher B, Avelar RL, Bergdahl J, Bertucci V, Bodokh I, Carruthers JA, Cartier H, Delmar H, Denfeld R, Gross JE, Heckmann M, Heden P, Hilton S, Inglefield C, Ogilvie P, Sattler G, Sebastian M, Solish N, Swift A, Trevidic P. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients. Aesthet Surg J. 2020 Mar 23;40(4):413-429. doi: 10.1093/asj/sjz110.
PubMed 30951166
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split-Face Study Comparing OnabotulinumtoxinA (Botox) and PrabotulinumtoxinA (Jeuveau) in Treating Glabellar Lines
- ClinicalTrials.gov ID
- NCT04715048
- Acronym / sponsor ID
- HS-19-00455
- Conditions
- Glabellar Frown Lines
- Keywords
- Botox, Jeuveau
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
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 this study is to compare the efficacy and side effects of Botox and Jeuveau for glabellar lines.
Detailed description
After being informed about the study and potential risks, all patients given consent will receive Botox on one side of their face and Jueveau on the other. A random number generator will generate a list of 20 combinations of "1,2" or "2,1". "1,2" means the Botox (onabotulinumtoxin A) will be placed on the right side and "2,1" means that the Botox will be placed on the left. The other side will be injected with PrabotulinumtoxinA. 8-10 units will be injected into the designated glabella in 3 sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onabotulinumtoxin A | Experimental | Drug: Onabotulinum toxin A8-10 units of Botox will be injected in the glabellar lines in one side of the face in 3 different locations. This injection will happen once. |
| Prabotulinumtoxin A | Experimental | Drug: PrabotulinumtoxinA8-10 units of Jeuveau will be injected in the glabellar lines in the other side of the face in 3 different locations. This injection will happen once. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18
- Willingness to participate in the study and able to provide informed consent
Key exclusion criteria (5 listed)
- Inability to follow up for study duration
- Prior neurotoxin injection in the last 4 months
- Prior surgery to the glabellar area
- Any planned aesthetic procedure to the glabellar area during the study period
- Cardiac Patients
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 |
|---|---|---|
| PrabotulinumtoxinAAlso: JeuveauGlabellar line correction | Drug | Prabotulinumtoxin A |
| Onabotulinum toxin AAlso: BotoxGlabellar line correction | Drug | Onabotulinumtoxin A |
Primary outcome
Movement on a 10 point Frown Movement Scale at 3 weeks
Time frame: 3 weeks
10-point scale created by the investigator assessing movement of glabellar lines. Possible scores range from 0 (no movement) to 10 (movement).
6 secondary outcomes
Days to onset of neurotoxin
Time frame: Up to 2-4 days
Bruising from the injection on a scale of 1-10
Time frame: Up to 2-4 days
Pain from the injection on a scale of 1-10
Time frame: Up to 2-4 days
Headache from the injection on a scale of 1-10
Time frame: Up to 2-4 days
Movement on a 10 point Frown Movement Scale at 3 weeks
Time frame: 3 weeks
Change in glabellar lines on the Merz Score (0-4)
Time frame: At baseline and 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Background: PubMed 30951166Rzany BJ, Ascher B, Avelar RL, Bergdahl J, Bertucci V, Bodokh I, Carruthers JA, Cartier H, Delmar H, Denfeld R, Gross JE, Heckmann M, Heden P, Hilton S, Inglefield C, Ogilvie P, Sattler G, Sebastian M, Solish N, Swift A, Trevidic P. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients. Aesthet Surg J. 2020 Mar 23;40(4):413-429. doi: 10.1093/asj/sjz110.
- Individual participant dataSharing planned: No
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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 Early Phase 1 study testing PrabotulinumtoxinA and Onabotulinum toxin A in people with Glabellar Frown Lines, run by University of Southern California 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 2 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: status not confirmed, as of the sponsor's last update on 14 Dec 2023. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Movement on a 10 point Frown Movement Scale at 3 weeks (time frame: 3 weeks). 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 NCT04715048, 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 14 Dec 2023.