Brow PtosisPhase 4NCT01401803
Brow Lifting With Dysport
A Phase 4 study testing Dysport in people with Brow Ptosis and Lid Ptosis, run by Kenneth Beer at 1 site in United States.
Trial summary
The purpose of this study is to provide data to assess Dysport™ injections as a treatment therapy for brow ptosis. This study will assess the outcome of brow lifting with use of Dysport. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Brow Ptosis, Lid Ptosis
- What is being tested?
- Dysport
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2012
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects of any race, 25-75 years of age
- Mild to Moderate brow ptosis (2 or 3 on a 5-point Brow Positioning Grading Scale)
- Subject has signed the IRB-approved Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed
- Subject is able to follow study instructions and likely to complete all required visits, as assessed by the Treating Investigator
- Subject has had a urine pregnancy test evaluated as negative* within 7 days prior to planned study treatment, has used contraception for at least a month prior to planned study treatment, and agrees to use contraception for the duration of the study
- Subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study:
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- A female is considered of childbearing potential unless she is:
- postmenopausal for >12 months prior to study drug administration;
- without a uterus and/or both ovaries; or
- surgically sterile (e.g., tubal ligation) for >6 months prior to study drug administration.
- The following methods of contraception, if properly used, are generally considered reliable for females of childbearing potential who may participate in the study:
- hormonal contraceptives† (oral, patch, injection, implant);
- male condom with intra-vaginal spermicide or diaphragm or cervical cap with spermicide;
- vaginal contraceptive ring;
- intrauterine device;
- surgical sterilization (bilateral tubal ligation);
- partner vasectomized††; or
- total sexual abstinence*.
- Hormonal contraceptives must be started at least 90 days prior to study drug administration, and intra-uterine contraceptive device must be placed at least 30 days prior to study drug administration.
- Vasectomized >3 months or with a 0 sperm count; * Female subjects of childbearing potential who are not sexually active are not required to practice a reliable method of contraception. They may be enrolled at the Investigator's discretion provided that they are counseled to remain sexually inactive for the duration of the study and understand the possible risks involved in getting pregnant during the study.
Who cannot join
- Previous injection of botulinum toxin of any serotype within 6 months, Previous injection of semi-permanent fillers in the upper face (i.e. glabella, periorbital, temporal areas) within the last 12 months. Previous injection of permanent fillers in the upper face (i.e. glabella, periorbital, temporal areas) are excluded
- Subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
- Subjects planning a facial cosmetic procedure during the study period or with prior cosmetic procedures (i.e., surgery) or visible scars that may affect the evaluation of response
- Facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen upper facial rhytids even by physically spreading them apart
- Previous cosmetic surgery to the upper face (e.g., periorbital surgery, brow lift, eyelid or eyebrow surgery, etc.)
- Laser resurfacing, or soft tissue augmentation in the periocular area in the 12months preceding Visit 1
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- Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function
- Current use of aminoglycoside antibiotics, curare-like agents, or agents that might interfere with neuromuscular (skeletal) function
- Profound atrophy/excessive weakness of muscles in target areas of injection
- History of facial nerve palsy
- Any patients with known autoimmune disease or compromised immune systems ie HIV, AIDS or current chemotherapy
- Infection at the injection site or systemic infection (in this case, postpone study entry until one week following recovery)
- Allergy or sensitivity to any component of Dysport™
- Evidence of recent alcohol or drug abuse
- Medical and/or psychiatric problems that is severe enough to interfere with the study results (Investigator opinion)
- History of poor cooperation, non-compliance with medical treatment, or unreliability
- Exposure to an investigational drug study within 30 days of the Baseline Visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Kenneth R. Beer, M.D., PA
West Palm Beach, Florida, 33401
About this study
The purpose of this study is to provide data to assess Dysport™ injections as a treatment therapy for brow ptosis. This study will assess the outcome of brow lifting with use of Dysport.
Read the detailed description
One of the most common reasons that patients present to both dermatologists and plastic surgeons is for brow and lid ptosis. Although some patients that present for these entities require surgery, most will decline to have surgical intervention. Alternative treatments include brow lifting with botulinum toxins.
Brow lifting with botulinum toxins may be performed by injecting the muscles responsible for brow and lid depression. These muscles include: the corrugators, procerus, medical aspect of the frontalis and the depressor component of the orbicularis oculi muscles. By relaxing these muscles, the brow elevators may be able to lift the brow and help both brow and lid ptosis. This trial is unique as it utilizes Dysport to treat an entire anatomic muscle group (the brow depressors) rather than injecting isolated muscles._
- Conditions
- Brow Ptosis, Lid Ptosis
- Being tested
- Dysport
- Keywords
- periorbital, glabella, ptosis, eyelid, brow
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DysportDrug
Patients entering will be based on gender and assessment of the glabella region (including the corrugators, procerus, and medial frontalis muscles). Muscle mass will be graded separately for males and females as +, ++, or+++ (light/small, moderate/medium, or heavy/large). Male patients will receive 0.3 mL to 0.4 mL (60, 70, or 80 units) in five equally divided doses of Dysport™ and female patients will receive 0.25 mL to 0.35 mL (50, 60 or 70 units) in equally divided doses of Dysport™ at 5 designated injection sites in the glabellar region. On (Day0) patients will be treated with Dysport™ 10 to 20 units bilaterally to the depressor component of the orbicularis. The dosing for patients will be based on assessment of orbicularis muscle mass. Patients will receive .05 mL to 0.1 mL (10 or 20 units) in two equally divided doses of Dysport™. Muscle mass will not be graded based upon gender for this region.
| Study group | Role | What they receive |
|---|---|---|
| Dysport | Other | Dysport injections into the glabella and orbicularis oculi muscles with dose based on muscle mass. Receives: Drug: Dysport |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of brow ptosis with dysport injection
Subjects will be assessed using 5-point brow positioning grading scale at baseline, day 14, month 1,2,4 and 6 months.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Beer
- Collaborators
- Medicis Pharmaceutical Corporation
- Responsible party
- Sponsor-investigator, Kenneth Beer, Beer, Kenneth R., M.D., PA
- Investigators
- Kenneth Beer, M.D., Principal investigator, Kenneth Beer, M.D.,PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401803
- Sponsor's protocol ID
- BrowDysport2011
- Status last verified
- Sep 2013
- First submitted
- 22 Jul 2011
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Flynn TC, Carruthers JA, Carruthers JA, Clark RE 2nd. Botulinum A toxin (BOTOX) in the lower eyelid: dose-finding study. Dermatol Surg. 2003 Sep;29(9):943-50; discussion 950-1. doi: 10.1046/j.1524-4725.2003.29257.x.
PubMed 12930337Carruthers JA, Lowe NJ, Menter MA, Gibson J, Nordquist M, Mordaunt J, Walker P, Eadie N; BOTOX Glabellar Lines I Study Group. A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol. 2002 Jun;46(6):840-9. doi: 10.1067/mjd.2002.121356.
PubMed 12063480Carruthers A, Carruthers J, Said S. Dose-ranging study of botulinum toxin type A in the treatment of glabellar rhytids in females. Dermatol Surg. 2005 Apr;31(4):414-22; discussion 422. doi: 10.1111/j.1524-4725.2005.31107.
PubMed 15871316
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brow Lifting With Dysport
- ClinicalTrials.gov ID
- NCT01401803
- Acronym / sponsor ID
- BrowDysport2011
- Conditions
- Brow Ptosis, Lid Ptosis
- Keywords
- periorbital, glabella, ptosis, eyelid, brow
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kenneth Beer
- Collaborators
- Medicis Pharmaceutical Corporation
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Jul 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.
The purpose of this study is to provide data to assess Dysport™ injections as a treatment therapy for brow ptosis. This study will assess the outcome of brow lifting with use of Dysport.
Detailed description
One of the most common reasons that patients present to both dermatologists and plastic surgeons is for brow and lid ptosis. Although some patients that present for these entities require surgery, most will decline to have surgical intervention. Alternative treatments include brow lifting with botulinum toxins.
Brow lifting with botulinum toxins may be performed by injecting the muscles responsible for brow and lid depression. These muscles include: the corrugators, procerus, medical aspect of the frontalis and the depressor component of the orbicularis oculi muscles. By relaxing these muscles, the brow elevators may be able to lift the brow and help both brow and lid ptosis. This trial is unique as it utilizes Dysport to treat an entire anatomic muscle group (the brow depressors) rather than injecting isolated muscles._
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dysport | Other | Drug: DysportDysport injections into the glabella and orbicularis oculi muscles with dose based on muscle mass. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Healthy male or female subjects of any race, 25-75 years of age
- Mild to Moderate brow ptosis (2 or 3 on a 5-point Brow Positioning Grading Scale)
- Subject has signed the IRB-approved Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed
- Subject is able to follow study instructions and likely to complete all required visits, as assessed by the Treating Investigator
- Subject has had a urine pregnancy test evaluated as negative* within 7 days prior to planned study treatment, has used contraception for at least a month prior to planned study treatment, and agrees to use contraception for the duration of the study
Key exclusion criteria (17 listed)
- Previous injection of botulinum toxin of any serotype within 6 months, Previous injection of semi-permanent fillers in the upper face (i.e. glabella, periorbital, temporal areas) within the last 12 months. Previous injection of permanent fillers in the upper face (i.e. glabella, periorbital, temporal areas) are excluded
- Subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
- Subjects planning a facial cosmetic procedure during the study period or with prior cosmetic procedures (i.e., surgery) or visible scars that may affect the evaluation of response
- Facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen upper facial rhytids even by physically spreading them apart
- Previous cosmetic surgery to the upper face (e.g., periorbital surgery, brow lift, eyelid or eyebrow surgery, etc.)
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 |
|---|---|---|
| DysportPatients entering will be based on gender and assessment of the glabella region (including the corrugators, procerus, and medial frontalis muscles). Muscle mass will be graded separately for males and females as +, ++, or+++ (light/small, moderate/medium, or heavy/large). Male patients will receive 0.3 mL to 0.4 mL (60, 70, or 80 units) in five equally divided doses of Dysport™ and female patients will receive 0.25 mL to 0.35 mL (50, 60 or 70 units) in equally divided doses of Dysport™ at 5 designated injection sites in the glabellar region. On (Day0) patients will be treated with Dysport™ 10 to 20 units bilaterally to the depressor component of the orbicularis. The dosing for patients will be based on assessment of orbicularis muscle mass. Patients will receive .05 mL to 0.1 mL (10 or 20 units) in two equally divided doses of Dysport™. Muscle mass will not be graded based upon gender for this region. | Drug | Dysport |
Primary outcome
Correction of brow ptosis with dysport injection
Time frame: 6 Months
Subjects will be assessed using 5-point brow positioning grading scale at baseline, day 14, month 1,2,4 and 6 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 26 Sep 2013.
- Results publication: PubMed 12930337Flynn TC, Carruthers JA, Carruthers JA, Clark RE 2nd. Botulinum A toxin (BOTOX) in the lower eyelid: dose-finding study. Dermatol Surg. 2003 Sep;29(9):943-50; discussion 950-1. doi: 10.1046/j.1524-4725.2003.29257.x.
- Results publication: PubMed 12063480Carruthers JA, Lowe NJ, Menter MA, Gibson J, Nordquist M, Mordaunt J, Walker P, Eadie N; BOTOX Glabellar Lines I Study Group. A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol. 2002 Jun;46(6):840-9. doi: 10.1067/mjd.2002.121356.
- Results publication: PubMed 15871316Carruthers A, Carruthers J, Said S. Dose-ranging study of botulinum toxin type A in the treatment of glabellar rhytids in females. Dermatol Surg. 2005 Apr;31(4):414-22; discussion 422. doi: 10.1111/j.1524-4725.2005.31107.
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.
Kenneth Beer, M.D. principal investigator
Kenneth Beer, M.D.,PA
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 Dysport in people with Brow Ptosis and Lid Ptosis, run by Kenneth Beer 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 20 inclusion and 17 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 26 Sep 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?
Correction of brow ptosis with dysport injection (time frame: 6 Months). 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 NCT01401803, which also lists 3 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 26 Sep 2013.