Glabellar Frown LinesPhase 2NCT02303002
Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines
A Phase 2 study testing Botulinum Toxin Type A and Active Comparator botulinum toxin in people with Glabellar Frown Lines, run by Revance Therapeutics, Inc. at 1 site in Canada.
Trial summary
This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- Botulinum Toxin Type A and Active Comparator botulinum toxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to Jan 2016
- Phase
- Phase 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate or severe glabellar frown lines
- Female or male, 30 to 65 years of age in good general health
- Women of childbearing potential must agree to use an effective method of birth control during the course of the study
- Willing to refrain from receipt of facial fillers, laser treatments or use of products that affect skin remodeling and causes an active dermal response
Who cannot join
- Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
- Muscle weakness or paralysis, particularly in the treatment area
- Active skin disease or infections or irritation at the treatment area
- Facial asymmetry, deep dermal scarring, or inability to substantially lessen the glabellar frown lines by manually spreading them apart
- Treatment with Botulinum Toxin Type A in the face in the last 6 months or in the last 3 months anywhere in the body
Trial locations and contacts
1 site in 1 country.
About this study
This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.
- Conditions
- Glabellar Frown Lines
- Being tested
- Botulinum Toxin Type A, Active Comparator botulinum toxin, Placebo Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type ABiological
Intramuscular injection (IM)
Active Comparator botulinum toxinBiological
IM injection
Placebo ComparatorBiological
IM injection
| Study group | Role | What they receive |
|---|---|---|
| Dose A | Experimental | Dose A: Botulinum Toxin Type A Receives: Biological: Botulinum Toxin Type A |
| Dose B | Experimental | Dose B: Botulinum Toxin Type A Receives: Biological: Botulinum Toxin Type A |
| Dose C | Experimental | Dose C: Botulinum Toxin Type A Receives: Biological: Botulinum Toxin Type A |
| Dose D | Active comparator | Dose D: Botulinum Toxin Type A Receives: Biological: Active Comparator botulinum toxin |
| Dose E | Placebo comparator | Dose E: Placebo Receives: Biological: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown
Measured: Week 24
Duration of response assessed by investigator assessment of severity of glabellar lines at maximum frown from the date of injection to when subject reverts to baseline severity
Measured: Up to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionJan 2016
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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revance Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303002
- Sponsor's protocol ID
- RT002-CL002
- Other IDs
- CTA Control No. 179120, File No. 9427-R1312\1-22C
- Status last verified
- Mar 2016
- First submitted
- 25 Nov 2014
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bertucci V, Humphrey S, Carruthers J, Solish N, Muhn C, Swift A, Rubio RG, Shears G, Rosen N. Comparing Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA in Moderate and Severe Glabellar Lines: Additional Analyses From a Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Study. Dermatol Surg. 2017 Dec;43 Suppl 3:S262-S273. doi: 10.1097/DSS.0000000000001364.
PubMed 33065952Carruthers J, Solish N, Humphrey S, Rosen N, Muhn C, Bertucci V, Swift A, Metelitsa A, Rubio RG, Waugh J, Quiring J, Shears G, Carruthers A. Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo. Dermatol Surg. 2017 Nov;43(11):1321-1331. doi: 10.1097/DSS.0000000000001206.
PubMed 28614091
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines
- ClinicalTrials.gov ID
- NCT02303002
- Acronym / sponsor ID
- RT002-CL002
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Nov 2014 (estimated)
- 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 safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose A | Experimental | Biological: Botulinum Toxin Type ADose A: Botulinum Toxin Type A |
| Dose B | Experimental | Biological: Botulinum Toxin Type ADose B: Botulinum Toxin Type A |
| Dose C | Experimental | Biological: Botulinum Toxin Type ADose C: Botulinum Toxin Type A |
| Dose D | Active comparator | Biological: Active Comparator botulinum toxinDose D: Botulinum Toxin Type A |
| Dose E | Placebo comparator | Biological: Placebo ComparatorDose E: Placebo |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate or severe glabellar frown lines
- Female or male, 30 to 65 years of age in good general health
- Women of childbearing potential must agree to use an effective method of birth control during the course of the study
- Willing to refrain from receipt of facial fillers, laser treatments or use of products that affect skin remodeling and causes an active dermal response
Key exclusion criteria (5 listed)
- Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
- Muscle weakness or paralysis, particularly in the treatment area
- Active skin disease or infections or irritation at the treatment area
- Facial asymmetry, deep dermal scarring, or inability to substantially lessen the glabellar frown lines by manually spreading them apart
- Treatment with Botulinum Toxin Type A in the face in the last 6 months or in the last 3 months anywhere in the body
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 |
|---|---|---|
| Botulinum Toxin Type AIntramuscular injection (IM) | Biological | Dose A, Dose B, Dose C |
| Active Comparator botulinum toxinIM injection | Biological | Dose D |
| Placebo ComparatorIM injection | Biological | Dose E |
Primary outcome
Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown
Time frame: Week 24
Duration of response assessed by investigator assessment of severity of glabellar lines at maximum frown from the date of injection to when subject reverts to baseline severity
Time frame: Up to Week 36
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 9 Mar 2016.
- Derived from this study: PubMed 33065952Bertucci V, Humphrey S, Carruthers J, Solish N, Muhn C, Swift A, Rubio RG, Shears G, Rosen N. Comparing Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA in Moderate and Severe Glabellar Lines: Additional Analyses From a Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Study. Dermatol Surg. 2017 Dec;43 Suppl 3:S262-S273. doi: 10.1097/DSS.0000000000001364.
- Derived from this study: PubMed 28614091Carruthers J, Solish N, Humphrey S, Rosen N, Muhn C, Bertucci V, Swift A, Metelitsa A, Rubio RG, Waugh J, Quiring J, Shears G, Carruthers A. Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo. Dermatol Surg. 2017 Nov;43(11):1321-1331. doi: 10.1097/DSS.0000000000001206.
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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 Phase 2 study testing Botulinum Toxin Type A and Active Comparator botulinum toxin in people with Glabellar Frown Lines, run by Revance Therapeutics, Inc. at 1 site in Canada.
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 4 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: finished, as of the sponsor's last update on 9 Mar 2016. 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 Canada. 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. Some participants in this study may receive a placebo. 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 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?
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?
Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown (time frame: Week 24). The study lists 2 primary outcomes in all. 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 NCT02303002, 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 9 Mar 2016.