Skin AgingPhase 3NCT01818076
Open Label Study to Assess Long-term Safety of Repeat Administration of Botulinum Toxin Type A for Moderate to Severe Crow's Feet 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 study will evaluate the long-term safety of botulinum toxin type A for the treatment of moderate to severe crow's feet lines after repeat application. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Aging
- What is being tested?
- Botulinum Toxin Type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2013
- 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 years and older
- 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 years of age and above and in good general health
- Women of childbearing potential 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 3 months
- Chemical peel during the 9 months prior to treatment
- Use of prescription retinoid products during the 3 months prior to treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, 37203
About this study
This study will evaluate the long-term safety of botulinum toxin type A for the treatment of moderate to severe crow's feet lines after repeat application.
- Conditions
- Skin Aging
- Being tested
- Botulinum Toxin Type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A, Dose A applied to the lateral canthal area
| Study group | Role | What they receive |
|---|---|---|
| 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.
Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments
Measured: Up to 24 months
Incidences of treatment-emergent laboratory, skin erythema, cranial nerve, and ocular irritation abnormalities when the drug product is administered in repeated treatments
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionDec 2013
Why it stopped: Sponsor decision to terminate study (not due to safety reasons)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 311 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
- NCT01818076
- Sponsor's protocol ID
- RT001-CL023
- Status last verified
- Apr 2014
- First submitted
- 20 Mar 2013
- Last updated
- 7 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Assess Long-term Safety of Repeat Administration of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
- ClinicalTrials.gov ID
- NCT01818076
- Acronym / sponsor ID
- RT001-CL023
- Conditions
- Skin Aging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to terminate study (not due to safety reasons)
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Mar 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 evaluate the long-term safety of botulinum toxin type A for the treatment of moderate to severe crow's feet lines after repeat application.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose A | Experimental | Drug: Botulinum Toxin Type ADose A: Botulinum toxin type A |
Who may qualify
- Ages
- 18 years and older
- 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 years of age and above and in good general health
- Women of childbearing potential must agree to use an effective method of birth control during the course of the study
Key exclusion criteria (7 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 3 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 |
|---|---|---|
| Botulinum Toxin Type ABotulinum toxin type A, Dose A applied to the lateral canthal area | Drug | Dose A |
Primary outcome
Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments
Time frame: Up to 24 months
Incidences of treatment-emergent laboratory, skin erythema, cranial nerve, and ocular irritation abnormalities when the drug product is administered in repeated treatments
Time frame: Up to 24 months
Results and safety
The study was stopped early (reason given: Sponsor decision to terminate study (not due to safety reasons)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 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 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 7 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: stopped early, as of the sponsor's last update on 7 May 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. 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 was stopped early (reason given: Sponsor decision to terminate study (not due to safety reasons)). Results are not available in the source record.
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?
Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments (time frame: Up to 24 months). 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?
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 7 May 2014; AzTrials last refreshed its copy on 6 Nov 2026.