Skin AgingPhase 3REALISE 1NCT02580370
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines
A Phase 3 study testing Botulinum toxin type A in people with Skin Aging, run by Revance Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a safety and efficacy study of botulinum toxin type A in subjects with lateral canthal lines. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Skin Aging
- What is being tested?
- Botulinum toxin type A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Aug 2016
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In good general health
- Moderate to severe lateral canthal lines when evaluated at rest based on the investigator's global assessment
- Moderate to severe lateral canthal lines when evaluated at rest based on the patient assessment of severity
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 area receiving study treatment
- Active skin disease or irritation or disrupted barrier at the treatment area
- Active eye disease or irritation
- Eyelid ptosis, excessive dermatochalasis, deep dermal scarring, or inability to substantially effect the LCL to be treated by manually spreading the skin apart
- Use of topical prescription retinoid product(s) in the lateral canthal areas during the 3 months prior to Screening
- Undergone any procedures that may affect the lateral canthal region during the 12 months prior to Screening
- Treatment with botulinum toxin type A in the lateral canthal areas in the 6 months prior to Screening or 3 months anywhere else 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 lateral canthal lines.
- Conditions
- Skin Aging
- Being tested
- Botulinum toxin type A, Placebo comparator
- Keywords
- REALISE 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ABiological
Topical botulinum toxin type A
Placebo comparatorBiological
Topical placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Dose A | Experimental | Botulinum toxin type A Receives: Biological: Botulinum toxin type A |
| Dose B | Placebo comparator | Placebo comparator Receives: Biological: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint based upon the investigator global assessment (IGA-LCL) and patient assessment of severity (PSA) of lateral canthal lines
Measured: Week 4
Secondary outcomes (4)
Investigator Global Assessment with 2 points or greater improvement from baseline
Proportion of subjects with 2 points or greater improvement from baseline using the Investigator Global Assessment
Measured: Week 4
Investigator Global Assessment with 1 point or greater improvement from baseline
Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment
Measured: Week 4
Patient Severity Assessment with 2 points or greater improvement from baseline
Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment
Measured: Week 4
Patient Severity Assessment with 1 points or greater improvement from baseline
Proportion of subjects with a 1 point or greater improvement from baseline using the Patient Severity Assessment
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 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
- NCT02580370
- Sponsor's protocol ID
- RT001-CL038
- Acronym
- REALISE 1
- Status last verified
- Sep 2016
- First submitted
- 15 Oct 2015
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines
- ClinicalTrials.gov ID
- NCT02580370
- Acronym / sponsor ID
- REALISE 1 / RT001-CL038
- Conditions
- Skin Aging
- Keywords
- REALISE 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 20 Oct 2015 (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 lateral canthal lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose A | Experimental | Biological: Botulinum toxin type ABotulinum toxin type A |
| Dose B | Placebo comparator | Biological: Placebo comparatorPlacebo comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- In good general health
- Moderate to severe lateral canthal lines when evaluated at rest based on the investigator's global assessment
- Moderate to severe lateral canthal lines when evaluated at rest based on the patient assessment of severity
Key exclusion criteria (8 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 area receiving study treatment
- Active skin disease or irritation or disrupted barrier at the treatment area
- Active eye disease or irritation
- Eyelid ptosis, excessive dermatochalasis, deep dermal scarring, or inability to substantially effect the LCL to be treated by manually spreading the skin apart
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 ATopical botulinum toxin type A | Biological | Dose A |
| Placebo comparatorTopical placebo comparator | Biological | Dose B |
Primary outcome
Composite endpoint based upon the investigator global assessment (IGA-LCL) and patient assessment of severity (PSA) of lateral canthal lines
Time frame: Week 4
4 secondary outcomes
Investigator Global Assessment with 2 points or greater improvement from baseline
Time frame: Week 4
Investigator Global Assessment with 1 point or greater improvement from baseline
Time frame: Week 4
Patient Severity Assessment with 2 points or greater improvement from baseline
Time frame: Week 4
Patient Severity Assessment with 1 points or greater improvement from baseline
Time frame: Week 4
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 Sep 2016.
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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 3 study testing Botulinum toxin type A in people with Skin Aging, run by Revance Therapeutics, Inc. 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 3 inclusion and 8 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 Sep 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 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Composite endpoint based upon the investigator global assessment (IGA-LCL) and patient assessment of severity (PSA) of lateral canthal lines (time frame: Week 4). 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 9 Sep 2016.