Platysma BandsPhase 1/2NCT04886167
Dysport Dose-Ranging Treatment of Platysmal Bands
A Phase 1/2 study testing AbobotulinumtoxinA in people with Platysma Bands, run by Clinical Testing of Beverly Hills at 1 site in United States.
Trial summary
This is a double-blinded, dose-ranging study in the US to assess the efficacy, safety, and duration of response of abobotulinumtoxinA for the treatment of moderate to severe platysmal bands. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Platysma Bands
- What is being tested?
- AbobotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2021to 1 Nov 2022
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 65 years of age.
- Moderate to severe platysmal bands (grade 3 or 4 on the Photographic Platysma Bands Scale, which ranges from 1 [minimal] to 5 [extreme]) at rest and at maximum contraction as assessed by the Investigator Live Assessment (ILA).
- Females of non-childbearing potential (i.e., post-menopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], or has undergone hysterectomy or bilateral oophorectomy) or
- Females of childbearing potential with a negative urine pregnancy test at screening and baseline, and agrees to use a highly effective and approved contraceptive method for the duration of the study. A highly effective method of contraception is defined as:
- Bilateral tubal ligation;
- Combined (estrogen and progesterone containing) oral, intravaginal or transdermal contraceptives that inhibit ovulation as the primary mode of action, on a stable dose for at least 28 days prior to screening visit;
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- Intrauterine device (IUD) inserted at least 28 days prior to screening visit;
- Intrauterine hormone-releasing system;
- Partner vasectomized for at least three months prior to screening visit;
- Progestogen -only oral, injectable or implantable contraceptives that inhibit ovulation as the primary mode of action, on a stable dose for at least 28 days prior to screening visit; or prior to screening visit; or
- Strict abstinence (i.e., refraining from heterosexual intercourse for the entire duration of the subject's participation in the study).
- Time and ability to complete the study and comply with instructions.
- Understands the study requirements and signed the informed consent form (ICF).
Who cannot join
- Botulinum toxin treatment of any serotype below the lower orbital rim, in the neck or chest within 12 months prior to study treatment.
- Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product).
- Known hypersensitivity to any component of the study product, or allergy to cow's milk protein* (according to the package insert/information).
- This criterion does not exclude subjects who are lactose intolerant. Lactose intolerance is a gastrointestinal disorder caused by an enzyme deficiency (lactase). An allergy to cow's milk protein is an immunological disorder that results in a systemic reaction, such as anaphylaxis.
- Known allergy or sensitivity to any botulinum toxin serotype.
- Female who is breast-feeding.
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- Female who intends to conceive a child during the study.
- Current smoker of any kind (e.g., tobacco, cloves, marijuana, vape pens, hookah, etc.), and agrees not to smoke for the duration of the study.
- Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy to the lower face (i.e., below the level of the bottom of the nose), neck or chest within 12 months prior to study treatment.
- Previous use of any permanent (non-biodegradable) or semi-permanent (e.g., calcium hydroxylapatite, Poly-L-lactic acid, polymethyl methacrylate, etc.) facial tissue augmentation therapy, lifting sutures, permanent implants or autologous fat to the lower face (i.e., below the level of the bottom of the nose), neck or chest within 24 months prior to study treatment.
- History of lower face (i.e., below the level of the bottom of the nose), neck or chest surgery, aesthetic procedures (e.g. ablative skin resurfacing, laser, microneedling, chemical peel, micro-focused ultrasound, deoxycholic acid injections, micro-needling, non- surgical fat reduction procedure) in the previous 12 months, or any other procedures which the Investigator's opinion would interfere with study evaluations.
- Planned surgery or aesthetic procedures to the lower face (i.e., below the level of the bottom of the nose), neck or chest (e.g. ablative skin resurfacing, laser, mesotherapy, Platelet-Rich Plasma (PRP) treatment, chemical peel, micro-focused ultrasound, deoxycholic acid injections, micro-needling, non-surgical fat reduction procedure) during the study period.
- Clinically significant abnormal focused physical examination finding(s) at screening or baseline visits.
- History of clavicular or sternal fracture.
- Presence of inflammation, active infection or skin disorder, such as eczema, rosacea, psoriasis, pseudofolliculitis barbae, herpes zoster etc, near (i.e., superior to the clavicle and inferior to the mandible) or in the platysmal bands area.
- History of neck pain, cervical disc degeneration, cervical dystonia, previous cervical neck surgeries, arm pain, numbness or weakness, asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, or breathing difficulties.
- History or presence of cancerous or pre-cancerous lesions, or radiation near (i.e., superior to the clavicle and inferior to the mandible) or in the platysmal bands area.
- Marked lower face (i.e., below the level of the bottom of the nose) or neck asymmetry, excessive neck skin or subcutaneous neck fat; excessive skin laxity, sagging, or banding; or deep horizontal neck folds.
- Presence of scars, hair, or tattoos (facial, neck or chest) in the treatment area that may interfere with study evaluations.
- History of bleeding disorder or current use of anticoagulant.
- History or presence of any medical condition that may put the subject at increased risk with exposure to botulinum toxin including diagnosed myasthenia gravis, Lambert-Eaton- syndrome, amyotrophic lateral sclerosis, voice disorders (aphonia, dysphonia, etc.), stroke, facial nerve palsy, or any other condition that might interfere with neuromuscular function.
- Use of medications that affect neuromuscular transmission such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases, and aminoglycoside antibiotics.
- Use of a muscle relaxant within 2 weeks prior to study treatment or planned use during the study.
- Treatment with any investigational drug or device within 30 days prior to study treatment.
- Any prior or current psychiatric illness (e.g. psychosis, depression, anxiety), alcohol or drug abuse, or is taking antidepressant, anxiolytic, or antipsychotic medication that, in the Investigator's opinion, could affect the subject's safety and/or the conduct or outcome of the study.
- Other concurrent medical conditions, therapy or other condition that, in the Investigator's opinion, would interfere with the evaluation of the study medication safety or efficacy and/or put the subject at risk if he/she participates to the study.
- Study center personnel, close relatives of the study center personnel (e.g. parents, children, siblings, or spouse), employees or close relatives of employees at the Sponsor company.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Testing of Beverly Hills
Encino, California, 91436
About this study
Official title: A Dose-Ranging Study to Evaluate the Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Platysmal Bands
This is a double-blinded, dose-ranging study in the US to assess the efficacy, safety, and duration of response of abobotulinumtoxinA for the treatment of moderate to severe platysmal bands.
Read the detailed description
This study is intended to evaluate the efficacy and safety of an initial dose of 120 U, 180 U, and 240 U of abobotulinumtoxinA (with optional touch-up) in the treatment of moderate to severe platysmal bands. The platysmal bands will be treated by intramuscular injection of abobotulinumtoxinA.
- Conditions
- Platysma Bands
- Being tested
- AbobotulinumtoxinA
- Keywords
- AbobotulinumtoxinA, Platysmal Bands
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbobotulinumtoxinADrug
Also called Dysport
Injection of platysmal bands.
| Study group | Role | What they receive |
|---|---|---|
| 120U abobotulinumtoxinA | Active comparator | Treatment of platysmal bands using a total of 120 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.025mL (5 U).
At the 14 day visit, an optional touch-up using up to 90 U of abobotulinumtoxinA can be performed. This will involve up to 18 injection sites, with each injection site receiving 0.025mL (5 U). Receives: Drug: AbobotulinumtoxinA |
| 180U abobotulinumtoxinA | Active comparator | Treatment of platysmal bands using a total of 180 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.0375mL (7.5 U).
At the 14 day visit, an optional touch-up using up to 90 U of abobotulinumtoxinA can be performed. This will involve up to 12 injection sites, with each injection site receiving 0.0375mL (7.5 U). Receives: Drug: AbobotulinumtoxinA |
| 240U abobotulinumtoxinA | Active comparator | Treatment of platysmal bands using a total of 240 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.05mL (10 U).
At the 14 day visit, an optional touch-up using up to 120 U of abobotulinumtoxinA can be performed. This will involve up to 12 injection sites, with each injection site receiving 0.05mL (10 U). Receives: Drug: AbobotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Live Assessment (Dynamic) - 1 month
Responder rate at 1 month using the Investigator Live Assessment 5-point Photographic Scale at maximum contraction. The scale ranges from 1 to 5, with higher scores meaning a worse outcome.
Measured: 1 month
Secondary outcomes (5)
Investigator Live Assessment (Dynamic)
Responder rate at each post-treatment visit using the Investigator Live Assessment 5-point Photographic Scale at maximum contraction. The scale ranges from 1 to 5, with higher scores meaning a worse outcome.
Measured: 5 months
Subject Self Assessment (Dynamic)
Responder rate at each post-treatment visit using the Subject Self Assessment 5-point Photographic Scale at maximum contraction. The scale ranges from 1 to 5, with higher scores meaning a worse outcome.
Measured: 5 months
Investigator Live Assessment (At Rest)
Responder rate at each post-treatment visit using the Investigator Live Assessment 5-point Photographic Scale at rest. The scale ranges from 1 to 5, with higher scores meaning a worse outcome.
Measured: 5 months
Subject Self Assessment (At Rest)
Responder rate at each post-treatment visit using the Subject Self Assessment 5-point Photographic Scale at rest. The scale ranges from 1 to 5, with higher scores meaning a worse outcome.
Measured: 5 months
Response Duration
Time to loss of a grade 1 or 2 for both Investigator Live Assessment Scale and Subject Self Assessment Scale at maximum contraction and at rest. The scale ranges from 1 to 5, with higher scores meaning a worse outcome.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start30 May 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Platysma BandsStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Testing of Beverly Hills
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Sponsor
- Investigators
- John Joseph, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886167
- Sponsor's protocol ID
- CTBH-01-2021
- Status last verified
- Oct 2022
- First submitted
- 5 May 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monheit GD, Pickett A. AbobotulinumtoxinA: A 25-Year History. Aesthet Surg J. 2017 May 1;37(suppl_1):S4-S11. doi: 10.1093/asj/sjw284.
PubMed 28388718Carruthers J, Carruthers A. The evolution of botulinum neurotoxin type A for cosmetic applications. J Cosmet Laser Ther. 2007 Sep;9(3):186-92. doi: 10.1080/14764170701411470.
PubMed 17763029Matarasso A, Matarasso SL, Brandt FS, Bellman B. Botulinum A exotoxin for the management of platysma bands. Plast Reconstr Surg. 1999 Feb;103(2):645-52; discussion 653-5. doi: 10.1097/00006534-199902000-00043.
PubMed 9950556Brandt FS, Bellman B. Cosmetic use of botulinum A exotoxin for the aging neck. Dermatol Surg. 1998 Nov;24(11):1232-4. doi: 10.1111/j.1524-4725.1998.tb04103.x.
PubMed 9834744Kane MA. Nonsurgical treatment of platysmal bands with injection of botulinum toxin A. Plast Reconstr Surg. 1999 Feb;103(2):656-63; discussion 664-5. doi: 10.1097/00006534-199902000-00045.
PubMed 9950557
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Ranging Study to Evaluate the Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Platysmal Bands
- ClinicalTrials.gov ID
- NCT04886167
- Acronym / sponsor ID
- CTBH-01-2021
- Conditions
- Platysma Bands
- Keywords
- AbobotulinumtoxinA, Platysmal Bands
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Clinical Testing of Beverly HillsUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 30 May 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 13 May 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.
This is a double-blinded, dose-ranging study in the US to assess the efficacy, safety, and duration of response of abobotulinumtoxinA for the treatment of moderate to severe platysmal bands.
Detailed description
This study is intended to evaluate the efficacy and safety of an initial dose of 120 U, 180 U, and 240 U of abobotulinumtoxinA (with optional touch-up) in the treatment of moderate to severe platysmal bands. The platysmal bands will be treated by intramuscular injection of abobotulinumtoxinA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 120U abobotulinumtoxinA | Active comparator | Drug: AbobotulinumtoxinATreatment of platysmal bands using a total of 120 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.025mL (5 U). At the 14 day visit, an optional touch-up using up to 90 U of abobotulinumtoxinA can be performed. This will involve up to 18 injection sites, with each injection site receiving 0.025mL (5 U). |
| 180U abobotulinumtoxinA | Active comparator | Drug: AbobotulinumtoxinATreatment of platysmal bands using a total of 180 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.0375mL (7.5 U). At the 14 day visit, an optional touch-up using up to 90 U of abobotulinumtoxinA can be performed. This will involve up to 12 injection sites, with each injection site receiving 0.0375mL (7.5 U). |
| 240U abobotulinumtoxinA | Active comparator | Drug: AbobotulinumtoxinATreatment of platysmal bands using a total of 240 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.05mL (10 U). At the 14 day visit, an optional touch-up using up to 120 U of abobotulinumtoxinA can be performed. This will involve up to 12 injection sites, with each injection site receiving 0.05mL (10 U). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female, 18 to 65 years of age.
- Moderate to severe platysmal bands (grade 3 or 4 on the Photographic Platysma Bands Scale, which ranges from 1 [minimal] to 5 [extreme]) at rest and at maximum contraction as assessed by the Investigator Live Assessment (ILA).
- Females of non-childbearing potential (i.e., post-menopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], or has undergone hysterectomy or bilateral oophorectomy) or
- Females of childbearing potential with a negative urine pregnancy test at screening and baseline, and agrees to use a highly effective and approved contraceptive method for the duration of the study. A highly effective method of contraception is defined as:
- Time and ability to complete the study and comply with instructions.
Key exclusion criteria (27 listed)
- Botulinum toxin treatment of any serotype below the lower orbital rim, in the neck or chest within 12 months prior to study treatment.
- Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product).
- Known hypersensitivity to any component of the study product, or allergy to cow's milk protein* (according to the package insert/information).
- This criterion does not exclude subjects who are lactose intolerant. Lactose intolerance is a gastrointestinal disorder caused by an enzyme deficiency (lactase). An allergy to cow's milk protein is an immunological disorder that results in a systemic reaction, such as anaphylaxis.
- Known allergy or sensitivity to any botulinum toxin serotype.
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 |
|---|---|---|
| AbobotulinumtoxinAAlso: DysportInjection of platysmal bands. | Drug | 120U abobotulinumtoxinA, 180U abobotulinumtoxinA, 240U abobotulinumtoxinA |
Primary outcome
Investigator Live Assessment (Dynamic) - 1 month
Time frame: 1 month
Responder rate at 1 month using the Investigator Live Assessment 5-point Photographic Scale at maximum contraction. The scale ranges from 1 to 5, with higher scores meaning a worse outcome.
5 secondary outcomes
Investigator Live Assessment (Dynamic)
Time frame: 5 months
Subject Self Assessment (Dynamic)
Time frame: 5 months
Investigator Live Assessment (At Rest)
Time frame: 5 months
Subject Self Assessment (At Rest)
Time frame: 5 months
Response Duration
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Background: PubMed 28388718Monheit GD, Pickett A. AbobotulinumtoxinA: A 25-Year History. Aesthet Surg J. 2017 May 1;37(suppl_1):S4-S11. doi: 10.1093/asj/sjw284.
- Background: PubMed 17763029Carruthers J, Carruthers A. The evolution of botulinum neurotoxin type A for cosmetic applications. J Cosmet Laser Ther. 2007 Sep;9(3):186-92. doi: 10.1080/14764170701411470.
- Background: PubMed 9950556Matarasso A, Matarasso SL, Brandt FS, Bellman B. Botulinum A exotoxin for the management of platysma bands. Plast Reconstr Surg. 1999 Feb;103(2):645-52; discussion 653-5. doi: 10.1097/00006534-199902000-00043.
- Background: PubMed 9834744Brandt FS, Bellman B. Cosmetic use of botulinum A exotoxin for the aging neck. Dermatol Surg. 1998 Nov;24(11):1232-4. doi: 10.1111/j.1524-4725.1998.tb04103.x.
- Background: PubMed 9950557Kane MA. Nonsurgical treatment of platysmal bands with injection of botulinum toxin A. Plast Reconstr Surg. 1999 Feb;103(2):656-63; discussion 664-5. doi: 10.1097/00006534-199902000-00045.
- Individual participant dataSharing planned: No
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
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AbobotulinumtoxinA in people with Platysma Bands, run by Clinical Testing of Beverly Hills 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 13 inclusion and 27 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 12 Oct 2022. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Investigator Live Assessment (Dynamic) - 1 month (time frame: 1 month). 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 NCT04886167, which also lists 5 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 12 Oct 2022.