Injection Site DiscomfortPhase 4NCT06161246
A Controlled Study on Pain Management With Injection of Botulinum Toxin for Glabellar Line Correction
A Phase 4 study testing Vibrating Beauty Bar in people with Injection Site Discomfort, run by Galderma R&D at 1 site in United States.
Trial summary
This is an open-label, single-center, randomized, split-face, controlled study to assess the effect of comfort intervention on pain during treatment injection compared against non-comfort intervention. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Site Discomfort
- What is being tested?
- Vibrating Beauty Bar
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to 15 Feb 2024
- Phase
- Phase 4
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult subjects aged 18-65 years
- Females or males
- Having any Fitzpatrick skin types I-VI
- Any races and ethnicities
- Having any self-assessed pain tolerance, with a minimum of 5 subjects in each category (low, medium, and high pain tolerance)
- Subject with intent to undergo correction of the glabellar lines (frown lines between the eyebrows)
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- Subject with moderate-to-severe glabellar lines as assessed by investigator using Glabellar Line Severity Scale (GLSS).
- Subject with no history of aesthetic injection, i.e., botulinum toxin, collagen, hyaluronic acid, calcium hydroxyapatite, poly L-lactic acid or permanent materials.
- Subject with healthy immune systems
- Subject willing to abstain from any other facial plastic surgical or cosmetic procedure(s) during the duration of the study.
- For female subjects of childbearing potential, she must not be pregnant, breastfeeding or planning pregnancy during the course of the study. Subjects must be willing to take a urine pregnancy test (UPT) prior to all treatment injections.
- Ability of giving consent for participation in the study
- Agreement to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments
Who cannot join
- Pregnant, breastfeeding, or planning pregnancy during the course of the study, confirmed by UPT.
- Current smokers or consumer nicotine (e.g., cigarettes, e-cigarettes, vaping device with pre-filled pods, vapor tank or mod, chewing tobacco)
- History of allergy or hypersensitivity to botulinum toxin type A, human albumin, lactose, or cow's milk protein
- Subject with signs and symptoms of eyelid or brow ptosis, inability to substantially lessen glabellar lines by physically spreading them apart, or history or presence of facial nerve palsy, as judged by the Investigator.
- Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
- Previous aesthetic treatment in the face with any of the following injection prior to the baseline visit:
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- Botulinum toxin
- Collagen, hyaluronic acid
- Calcium hydroxylapatite, poly L-lactic acid, fat or permanent materials (non-biodegradable)
- Previous treatment/procedure in the face in the previous 2-4 weeks that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study e.g.,
- Resurfacing (laser, photo modulation, light, radiofrequency, ultrasound, chemical peel, dermabrasion, or other ablative/non-ablative procedures)
- Needling or mesotherapy
- Cryotherapy
- Presence of any disease or lesions near or on the glabellar region, e.g.,
- Inflammation, active, or chronic infection in or near the treatment area
- Psoriasis, eczema, rosacea, atopic dermatitis, herpes zoster/herpes simplex, and acanthosis
- Scars or deformities
- History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation (e.g., aspirin or other non-steroidal anti-inflammatory drugs), omega 3, or vitamin E within 14 days before treatment. Omega 3 and vitamin E are acceptable only as part of a standard multivitamin formulation.
- Planning on having surgeries and/or invasive medical procedures during the course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Split-face, Controlled Study on Pain Management With Injection of Botulinum Toxin for Glabellar Line Correction
This is an open-label, single-center, randomized, split-face, controlled study to assess the effect of comfort intervention on pain during treatment injection compared against non-comfort intervention.
- Conditions
- Injection Site Discomfort
- Being tested
- Vibrating Beauty Bar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating Beauty BarDevice
Also called Vibration therapy
A vibrating beauty bar will be used at the injection site for patient comfort.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Subjects will be treated for correction of glabellar lines with Dysport and comfort intervention on one side and Dysport only on the other side depending on pre-determined randomization. Subjects will complete the study assessments and end the study. Receives: Device: Vibrating Beauty Bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Visual Analogue Scale is a 11-point psychometric scale that specifies the level of pain. Subject will be shown a photo of a VAS and verbally report a pain score between 0 and 10, which will be captured by a clinic staff. A score of 0 corresponds to no pain felt and a score of 10 corresponds to very high pain.
Measured: Baseline
Secondary outcomes (1)
Self-assessment questionnaire
To evaluate investigator and subject's satisfaction and preference on treatment experience using self-assessment questionnaires on treatment injection with and without comfort intervention
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start23 Oct 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection Site DiscomfortStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will receive comfort intervention on one side of face, and will not receive comfort intervention on the other side of face.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DeNova Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161246
- Sponsor's protocol ID
- GLI.04.US.SL.028
- Status last verified
- Oct 2023
- First submitted
- 30 Nov 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Split-face, Controlled Study on Pain Management With Injection of Botulinum Toxin for Glabellar Line Correction
- ClinicalTrials.gov ID
- NCT06161246
- Acronym / sponsor ID
- GLI.04.US.SL.028
- Conditions
- Injection Site Discomfort
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Collaborators
- DeNova Research
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 7 Dec 2023 (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 an open-label, single-center, randomized, split-face, controlled study to assess the effect of comfort intervention on pain during treatment injection compared against non-comfort intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will receive comfort intervention on one side of face, and will not receive comfort intervention on the other side of face.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Vibrating Beauty BarSubjects will be treated for correction of glabellar lines with Dysport and comfort intervention on one side and Dysport only on the other side depending on pre-determined randomization. Subjects will complete the study assessments and end the study. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Adult subjects aged 18-65 years
- Females or males
- Having any Fitzpatrick skin types I-VI
- Any races and ethnicities
- Having any self-assessed pain tolerance, with a minimum of 5 subjects in each category (low, medium, and high pain tolerance)
Key exclusion criteria (19 listed)
- Pregnant, breastfeeding, or planning pregnancy during the course of the study, confirmed by UPT.
- Current smokers or consumer nicotine (e.g., cigarettes, e-cigarettes, vaping device with pre-filled pods, vapor tank or mod, chewing tobacco)
- History of allergy or hypersensitivity to botulinum toxin type A, human albumin, lactose, or cow's milk protein
- Subject with signs and symptoms of eyelid or brow ptosis, inability to substantially lessen glabellar lines by physically spreading them apart, or history or presence of facial nerve palsy, as judged by the Investigator.
- Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
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 |
|---|---|---|
| Vibrating Beauty BarAlso: Vibration therapyA vibrating beauty bar will be used at the injection site for patient comfort. | Device | Treatment Group |
Primary outcome
Visual Analogue Scale
Time frame: Baseline
Visual Analogue Scale is a 11-point psychometric scale that specifies the level of pain. Subject will be shown a photo of a VAS and verbally report a pain score between 0 and 10, which will be captured by a clinic staff. A score of 0 corresponds to no pain felt and a score of 10 corresponds to very high pain.
1 secondary outcome
Self-assessment questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- 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.
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 Phase 4 study testing Vibrating Beauty Bar in people with Injection Site Discomfort, run by Galderma R&D 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 19 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 22 Mar 2024. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analogue Scale (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2024.