Glabellar Frown LinesPhase 4DREAMNCT03687736
Subject Satisfaction With AbobutulinumtoxinA Treatment
A Phase 4 study testing AbobotulinumtoxinA in people with Glabellar Frown Lines, run by Galderma R&D at 6 sites in United States.
Trial summary
An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- AbobotulinumtoxinA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 Oct 2018to 4 Dec 2019
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderate to Severe Glabellar Lines at Maximum Frown
- Understands study requirements and signs an informed consent
Who cannot join
- Known allergy to any component of study product
- Pregnant or breast feeding or intending to get pregnant during the study
- Botulinum toxin treatment in the face within 9 months
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Galderma Study Site
Chicago, Illinois, 60654
Galderma Study Site
Greenwood Village, Colorado, 80111
Galderma Study Site
Los Angeles, California, 90025
Galderma Study Site
Omaha, Nebraska, 68144
Galderma Study Site
San Francisco, California, 94115
Galderma Study Site
Santa Monica, California, 90404
About this study
Official title: A Multicenter, Open-Label, Interventional Study to Evaluate Subject Satisfaction of AbobutulinumtoxinA Treatments in Moderate to Severe Glabellar Lines
An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment.
Read the detailed description
Following signature of informed consent and the screening process, eligible subjects were treated at the Baseline visit (Day 0) with abobotulinumtoxinA in the glabellar region. Subjects were re-treated at the Month 6 visit.
- Conditions
- Glabellar Frown Lines
- Being tested
- AbobotulinumtoxinA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbobotulinumtoxinABiological
AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6
| Study group | Role | What they receive |
|---|---|---|
| AbobotulinumtoxinA | Other | Open-label Receives: Biological: AbobotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines
Percentage of subjects satisfied with the treatment results assessed by satisfaction question at Month 12 visit.
Measured: 12 months
Secondary outcomes (6)
Subject Satisfaction With Aesthetic Outcome in Treated Area
based on Subject Satisfaction questionnaire data
Measured: Months 1,3,6,7,9 and 12
Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows
FACE-Q Appraisal of Lines: Between Eyebrows. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.
Measured: Months 1,3,6,7,9 and 12
Evaluate the Impact of Treatment; Psychological Function
FACE-Q Psychological Function. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.
Measured: Months 1,3,6,7,9 and 12
Subject Self-Assessment Using a 4-point Categorical Scale
Evaluate efficacy using a subject self-assessment scale that measures the severity of glabellar lines at maximum frown
Measured: Months 1,3,6,7,9 and 12
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity
Evaluate efficacy at visits using a 4-point photographic scale of glabellar line severity, by Investigator Live assessment at maximum frown.
Measured: Months 1,3,6,7,9 and 12
Onset of Treatment Response
Subject perception of treatment response
Measured: After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start2 Oct 2018
- Primary completion7 Nov 2019
- Study completion4 Dec 2019
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.
- Other trials for Glabellar Frown LinesStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687736
- Sponsor's protocol ID
- 43USD1802
- Acronym
- DREAM
- Status last verified
- Mar 2020
- First submitted
- 19 Sep 2018
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Interventional Study to Evaluate Subject Satisfaction of AbobutulinumtoxinA Treatments in Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT03687736
- Acronym / sponsor ID
- DREAM / 43USD1802
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Posted 18 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment.
Detailed description
Following signature of informed consent and the screening process, eligible subjects were treated at the Baseline visit (Day 0) with abobotulinumtoxinA in the glabellar region. Subjects were re-treated at the Month 6 visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AbobotulinumtoxinA | Other | Biological: AbobotulinumtoxinAOpen-label |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate to Severe Glabellar Lines at Maximum Frown
- Understands study requirements and signs an informed consent
Key exclusion criteria (3 listed)
- Known allergy to any component of study product
- Pregnant or breast feeding or intending to get pregnant during the study
- Botulinum toxin treatment in the face within 9 months
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 |
|---|---|---|
| AbobotulinumtoxinAAbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6 | Biological | AbobotulinumtoxinA |
Primary outcome
Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines
Time frame: 12 months
Percentage of subjects satisfied with the treatment results assessed by satisfaction question at Month 12 visit.
6 secondary outcomes
Subject Satisfaction With Aesthetic Outcome in Treated Area
Time frame: Months 1,3,6,7,9 and 12
Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows
Time frame: Months 1,3,6,7,9 and 12
Evaluate the Impact of Treatment; Psychological Function
Time frame: Months 1,3,6,7,9 and 12
Subject Self-Assessment Using a 4-point Categorical Scale
Time frame: Months 1,3,6,7,9 and 12
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity
Time frame: Months 1,3,6,7,9 and 12
Onset of Treatment Response
Time frame: After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AbobotulinumtoxinA in people with Glabellar Frown Lines, run by Galderma R&D at 6 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 2 inclusion and 3 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 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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?
Yes. Results are posted in the registry (first posted 18 Mar 2020). 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?
Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines (time frame: 12 months). 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 26 Aug 2022.