Glabellar Frown LinesEarly Phase 1NCT05305768
Xeomin Treatment of Glabellar Lines Using OLD Versus COLD
A Early Phase 1 study testing IncobotulinumtoxinA in people with Glabellar Frown Lines, run by Clinical Testing of Beverly Hills at 2 sites in United States.
Trial summary
This is a blinded, randomized study in the US to compare the duration response of two different concentrations of Xeomin in healthy female subjects with moderate to severe dynamic glabellar lines on maximum frown. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- IncobotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2022to Feb 2023
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 Merz FWS 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.
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- 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
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Testing of Beverly Hills
Encino, California, 91436
Alexander Rivkin MD
Los Angeles, California, 90025
Clinical Research Coordinator, 310-443-5273
Alexander Rivkin, MD
About this study
Official title: A Randomized, Parallel-Group Study on the Duration Response of Highly Concentrated On Label Dose (COLD) of Xeomin® Compared to the On Label Dose and Concentration (OLD) in Subjects With Moderate to Severe Dynamic Glabellar Lines
This is a blinded, randomized study in the US to compare the duration response of two different concentrations of Xeomin in healthy female subjects with moderate to severe dynamic glabellar lines on maximum frown.
Read the detailed description
This study involves a blinded, randomized, parallel-group design. The aim of this study is to evaluate the duration response of Xeomin 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 0.05 mL and the OLD concentration is defined as 4 Units per 0.1 mL.
The total Xeomin 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 0.05 mL) group will receive a total of 0.25mL.
- Conditions
- Glabellar Frown Lines
- Being tested
- IncobotulinumtoxinA
- Keywords
- wrinkles, incobotulinumtoxinA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncobotulinumtoxinADrug
Also called Xeomin
Injection of glabellar rhytids
| Study group | Role | What they receive |
|---|---|---|
| OLD (4 U per 0.1 mL) | Active comparator | Participants will receive a total Xeomin dose of 20U using a 4U per 0.1mL concentration divided into 5 intramuscular injections performed once. Receives: Drug: IncobotulinumtoxinA |
| COLD (4 U per 0.05 mL group) | Active comparator | Participants will receive a total Xeomin dose of 20U using a 4U per 0.05mL concentration divided into 5 intramuscular injections performed once. Receives: Drug: IncobotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Duration
Time to return to baseline Facial Wrinkle Scale (FWS) score at maximum frown, as assessed by the blinded evaluating investigator.
The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
Measured: 180 days
Secondary outcomes (6)
Investigator Live Assessment (Dynamic)
Responder rate at each visit on the Facial Wrinkle Scale (FWS) at maximum frown, as assessed by the blinded evaluating investigator.
The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
Measured: 180 days
Subject Self Assessment (Dynamic)
Responder rate at each visit on the Facial Wrinkle Scale (FWS) at maximum frown, as assessed by the subject.
The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
Measured: 180 days
Investigator Live Assessment (At Rest)
Responder rate at each visit on the Facial Wrinkle Scale (FWS) at rest, as assessed by the blinded evaluating investigator.
The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
Measured: 180 days
Subject Self Assessment (At Rest)
Responder rate at each visit on the Facial Wrinkle Scale (FWS) at rest, as assessed by the subject.
The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
Measured: 180 days
Change from Baseline Score
Change from baseline in mean Facial Wrinkle Scale (FWS) score at maximum frown, as assessed by the blinded evaluating investigator, at each visit.
The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
Measured: 180 days
Change in Frontalis Function
Percentage of subjects with weakening of frontalis muscle function using the Frontalis Function Scale (FFS) compared to baseline, as assessed by the blinded evaluating investigator, at each visit.
The Frontalis Function Scale (FFS) scale ranges from a score of 0 to 3, and a higher score indicates greater reduction of forehead movement during maximal brow raise.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 May 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Testing of Beverly Hills
- Sponsor type
- University, hospital or other
- Collaborators
- Merz North America, Inc.
- Responsible party
- Sponsor
- Investigators
- John Joseph, MD, Principal investigator, Clinical Testing of Beverly Hills
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305768
- Sponsor's protocol ID
- CTBH-02-2021
- Status last verified
- Mar 2022
- First submitted
- 10 Nov 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carruthers J, Fagien S, Matarasso SL; Botox Consensus Group. Consensus recommendations on the use of botulinum toxin type a in facial aesthetics. Plast Reconstr Surg. 2004 Nov;114(6 Suppl):1S-22S. doi: 10.1097/01.PRS.0000144795.76040.D3.
PubMed 15507786Prager W, Bee EK, Havermann I, Zschocke I. Onset, longevity, and patient satisfaction with incobotulinumtoxinA for the treatment of glabellar frown lines: a single-arm, prospective clinical study. Clin Interv Aging. 2013;8:449-56. doi: 10.2147/CIA.S34854. Epub 2013 Apr 24.
PubMed 23650444
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group Study on the Duration Response of Highly Concentrated On Label Dose (COLD) of Xeomin® Compared to the On Label Dose and Concentration (OLD) in Subjects With Moderate to Severe Dynamic Glabellar Lines
- ClinicalTrials.gov ID
- NCT05305768
- Acronym / sponsor ID
- CTBH-02-2021
- Conditions
- Glabellar Frown Lines
- Keywords
- wrinkles, incobotulinumtoxinA
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clinical Testing of Beverly HillsUniversity, hospital or other
- Collaborators
- Merz North America, Inc.
- Study start
- 1 May 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 31 Mar 2022 (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.
This is a blinded, randomized study in the US to compare the duration response of two different concentrations of Xeomin in healthy female subjects with moderate to severe dynamic glabellar lines on maximum frown.
Detailed description
This study involves a blinded, randomized, parallel-group design. The aim of this study is to evaluate the duration response of Xeomin 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 0.05 mL and the OLD concentration is defined as 4 Units per 0.1 mL.
The total Xeomin 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 0.05 mL) group will receive a total of 0.25mL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OLD (4 U per 0.1 mL) | Active comparator | Drug: IncobotulinumtoxinAParticipants will receive a total Xeomin dose of 20U using a 4U per 0.1mL concentration divided into 5 intramuscular injections performed once. |
| COLD (4 U per 0.05 mL group) | Active comparator | Drug: IncobotulinumtoxinAParticipants will receive a total Xeomin dose of 20U using a 4U per 0.05mL concentration divided into 5 intramuscular injections performed once. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 Merz FWS 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.
Key exclusion criteria (20 listed)
- 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.
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 |
|---|---|---|
| IncobotulinumtoxinAAlso: XeominInjection of glabellar rhytids | Drug | COLD (4 U per 0.05 mL group), OLD (4 U per 0.1 mL) |
Primary outcome
Response Duration
Time frame: 180 days
Time to return to baseline Facial Wrinkle Scale (FWS) score at maximum frown, as assessed by the blinded evaluating investigator. The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
6 secondary outcomes
Investigator Live Assessment (Dynamic)
Time frame: 180 days
Subject Self Assessment (Dynamic)
Time frame: 180 days
Investigator Live Assessment (At Rest)
Time frame: 180 days
Subject Self Assessment (At Rest)
Time frame: 180 days
Change from Baseline Score
Time frame: 180 days
Change in Frontalis Function
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 15507786Carruthers J, Fagien S, Matarasso SL; Botox Consensus Group. Consensus recommendations on the use of botulinum toxin type a in facial aesthetics. Plast Reconstr Surg. 2004 Nov;114(6 Suppl):1S-22S. doi: 10.1097/01.PRS.0000144795.76040.D3.
- Background: PubMed 23650444Prager W, Bee EK, Havermann I, Zschocke I. Onset, longevity, and patient satisfaction with incobotulinumtoxinA for the treatment of glabellar frown lines: a single-arm, prospective clinical study. Clin Interv Aging. 2013;8:449-56. doi: 10.2147/CIA.S34854. Epub 2013 Apr 24.
- 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.
John Joseph, MD principal investigator
Clinical Testing of Beverly Hills
2 sites 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 IncobotulinumtoxinA in people with Glabellar Frown Lines, run by Clinical Testing of Beverly Hills at 2 sites 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 9 inclusion and 20 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Mary Hayes (747-998-5160, mary@clinicaltestingcenter.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Duration (time frame: 180 days). 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 NCT05305768, which also lists 2 linked publications.
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 31 Mar 2022.