Skin AgingPhase 2NCT01940991
Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
A Phase 2 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 study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet 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
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Nov 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe crow's feet lines
- Female or male, 18 to 65 years of age and in good general health
- Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study
Who cannot join
- Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A
- Muscle weakness or paralysis, particularly in the area receiving study treatment
- Active skin disease or irritation at the treatment area
- Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
- Treatment with Botulinum Toxin Type A for crow's feet lines in the last 6 months or 3 months anywhere in the body
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Research Institute
Coral Gables, Florida, 33146
About this study
This study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines
- Conditions
- Skin Aging
- Being tested
- Placebo, Botulinum Toxin Type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo, Dose B; dose applied to the lateral canthal lines
Botulinum Toxin Type A, Dose A, dose applied to the lateral canthal lines
| Study group | Role | What they receive |
|---|---|---|
| Dose B | Placebo comparator | Dose B: Placebo Receives: Drug: Placebo |
| Dose A | Experimental | Dose A: Botulinum Toxin Type A Receives: Drug: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint
Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines
Measured: Week 4
Secondary outcomes (3)
Investigator Global Assessment with 2 points or greater improvement from baseline
Proportion of subjects with 2 point 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionNov 2013
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 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
- NCT01940991
- Sponsor's protocol ID
- RT001-CL035
- Status last verified
- Dec 2013
- First submitted
- 9 Sep 2013
- Last updated
- 31 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
- ClinicalTrials.gov ID
- NCT01940991
- Acronym / sponsor ID
- RT001-CL035
- Conditions
- Skin Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 Sep 2013 (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 study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet 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 B | Placebo comparator | Drug: PlaceboDose B: Placebo |
| Dose A | Experimental | Drug: Botulinum Toxin Type ADose A: Botulinum Toxin Type A |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate to severe crow's feet lines
- Female or male, 18 to 65 years of age and in good general health
- Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study
Key exclusion criteria (5 listed)
- Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A
- Muscle weakness or paralysis, particularly in the area receiving study treatment
- Active skin disease or irritation at the treatment area
- Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
- Treatment with Botulinum Toxin Type A for crow's feet lines in the last 6 months or 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 |
|---|---|---|
| PlaceboPlacebo, Dose B; dose applied to the lateral canthal lines | Drug | Dose B |
| Botulinum Toxin Type ABotulinum Toxin Type A, Dose A, dose applied to the lateral canthal lines | Drug | Dose A |
Primary outcome
Composite endpoint
Time frame: Week 4
Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines
3 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
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 31 Jan 2014.
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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 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 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 31 Jan 2014. 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 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?
Composite endpoint (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 31 Jan 2014.