Brow PtosisPhase 4NCT01308593
Brow Enhancement Study
A Phase 4 study testing Juvederm XC and Botox in people with Brow Ptosis, run by Skin Care and Laser Physicians of Beverly Hills at 1 site in United States.
Trial summary
Investigation into brow aesthetics using Botox in Conjunction with Juvederm XC as evaluated by patient satisfaction Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Brow Ptosis
- What is being tested?
- Juvederm XC and Botox
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2011
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
Who cannot join
- Persons who have not had Botox for months.
- Women who are pregnant, breastfeeding, or trying to get pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Skin Care and Laser Physicians of Beverly Hills
Los Angeles, California, 90069
About this study
Official title: Investigation Into Brow Aesthetics Using Botox in Conjunction With Juvederm Ultra XC as Evaluated by Patient Satisfaction
Investigation into brow aesthetics using Botox in Conjunction with Juvederm XC as evaluated by patient satisfaction
- Conditions
- Brow Ptosis
- Being tested
- Juvederm XC, Botox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juvederm XCDevice
Filler
BotoxDrug
26 units dosed one time
| Study group | Role | What they receive |
|---|---|---|
| Juvederm XC | Active comparator | Juvederm XC Receives: Device: Juvederm XC |
| Botox | Active comparator | Medication used to block neuromuscular transmission Receives: Drug: Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant satisfaction with combined injection with Botox and Juvederm XC
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brow PtosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skin Care and Laser Physicians of Beverly Hills
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek H. Jones, M.D., Skin Care and Laser Physicians of Beverly Hills
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308593
- Sponsor's protocol ID
- Brow Study 25856/1
- Status last verified
- Jan 2013
- First submitted
- 2 Mar 2011
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into Brow Aesthetics Using Botox in Conjunction With Juvederm Ultra XC as Evaluated by Patient Satisfaction
- ClinicalTrials.gov ID
- NCT01308593
- Acronym / sponsor ID
- Brow Study 25856/1
- Conditions
- Brow Ptosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Skin Care and Laser Physicians of Beverly HillsUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 4 Mar 2011 (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.
Investigation into brow aesthetics using Botox in Conjunction with Juvederm XC as evaluated by patient satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Juvederm XC | Active comparator | Device: Juvederm XCJuvederm XC |
| Botox | Active comparator | Drug: BotoxMedication used to block neuromuscular transmission |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women
Key exclusion criteria (2 listed)
- Persons who have not had Botox for months.
- Women who are pregnant, breastfeeding, or trying to get pregnant.
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 |
|---|---|---|
| Juvederm XCFiller | Device | Juvederm XC |
| Botox26 units dosed one time | Drug | Botox |
Primary outcome
Participant satisfaction with combined injection with Botox and Juvederm XC
Time frame: 5 months
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 4 Jan 2013.
Related trials for Brow Ptosis
Not yet recruiting
Enhancing the Durability of Thread-Assisted Brow Suspension Through Upper Blepharoplasty-Assisted Ligament Release
Brow Ptosis, Dermatochalasis
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 4 study testing Juvederm XC and Botox in people with Brow Ptosis, run by Skin Care and Laser Physicians of Beverly Hills 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 1 inclusion and 2 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 4 Jan 2013. 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 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?
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?
Participant satisfaction with combined injection with Botox and Juvederm XC (time frame: 5 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 4 Jan 2013.