Mild to Moderate Temporal AtrophyPhase 4DPL-2010NCT01354743
Upper Facial Remodeling With Perlane-L and Dysport
A Phase 4 study testing Dysport and Perlane L in people with Mild to Moderate Temporal Atrophy and Moderate to Severe Glabellar Rhytids, run by Beer, Kenneth R., M.D., PA at 1 site in United States.
Trial summary
The purpose of this study is to provide data to support combination treatment of the upper face with Perlane-L® and Dysport™. This study will assess the outcome of upper face rejuvenation in the temporal fossa; outcome of glabella and/or periorbital regions will also be assessed as a secondary endpoint. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild to Moderate Temporal Atrophy, Moderate to Severe Glabellar Rhytids, Moderate to Severe Periorbital Rhytids
- What is being tested?
- Dysport and Perlane L
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to May 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatient,male or female subjects of any race, 40-75 years of age.
- Mild to Moderate temoral atrophy of (1 or 2 on Four Point Temporal Atrophy Scale)
- One of the following:
- Periocular rhytids characterized by a measurement of 3 or more during maximum attempted muscle contraction (during maximum smiling) upon evaluation using the Rao-Goldman 5 point Facial Wrinkle Scale.
- Mild to moderate glabella rhytiuds by a measurment of 3 or more upon evaluation using the Rao-Goldman 5-point Facial Wrinkle Scale.
- Subjects will be enrolled if previous history of facial cold sores, but will be medicated to avoid any recurrence.
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- able to understand the requirements of the study and sign a Institutional Review Board Informed Consent/HIPPA Authorization forms and receive a copy.
- Subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study: A female is considered of childbearing potential unless she is post menopausal 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 12 months 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™ and/or Perlane-L®.
- 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
Official title: Upper Facial Remodeling With Perlane-L and Dysport.
The purpose of this study is to provide data to support combination treatment of the upper face with Perlane-L® and Dysport™. This study will assess the outcome of upper face rejuvenation in the temporal fossa; outcome of glabella and/or periorbital regions will also be assessed as a secondary endpoint.
- Conditions
- Mild to Moderate Temporal Atrophy, Moderate to Severe Glabellar Rhytids, Moderate to Severe Periorbital Rhytids
- Being tested
- Dysport, Perlane L
- Keywords
- atrophy, rhytids, glabellar, periorbital
- Medical subject headings
- Atrophy
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 procerus and corrugator muscle mass. Muscle mass will be graded separately for males and females as +, ++, or+++ (light/small, moderate/medium, or heavy/large) by assessment of the procerus/corrugator muscles. Male patients will receive 0.3 mL to 0.4 mL (60, 70, or 80 units) in five equally divided doses of Dysport™ 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
Subjects will be treated with Dysport™ 20 or 30 units bilaterally to crow's feet.
Subjects will be treated at baseline and if maximum amount of product has not been used at 1 month follow up subject will receive a touch up. No further treatment will be done for the remaining study visits.
Perlane LDevice
The subject will be allowed to receive up to 4 mls between the temporal fossa and the glabella area.
| 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; Device: Perlane L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper face rejuvenation in the temporal fossa
Subjects are assessed from a Four Point Temporal Atropy scale at baseline(must present with a 1 or 2 score).Subject will be assessed at 1 month with additonal treatment if needed and return at month 3,6, and 9 months and be assessed with the Four Point Atrophy Scale.
Measured: 9months
Secondary outcomes (1)
Measure of rejuvenation in glabella and/or periorbital regions
Mild to moderate glabella rhytids and Periocular rhytids by a measurement of 3 or more upon evaluation using the Rao-Goldman 5-point Facial Wrinkle Scale.
Subject will be assessed at 1 month with additonal treatment if needed and return at month 3,6, and 9 months and be assessed with Rao-Goldman 5-point Facial Wrinkle Scale.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Temporal AtrophyStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beer, Kenneth R., M.D., PA
- Collaborators
- Medicis Pharmaceutical Corporation
- Responsible party
- Sponsor
- Investigators
- Kenneth Beer M.D., Principal investigator, Kenneth Beer, M.D., PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354743
- Sponsor's protocol ID
- DysportPerlaneL-2010
- Acronym
- DPL-2010
- Status last verified
- Sep 2013
- First submitted
- 11 May 2011
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
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
- Upper Facial Remodeling With Perlane-L and Dysport.
- ClinicalTrials.gov ID
- NCT01354743
- Acronym / sponsor ID
- DPL-2010 / DysportPerlaneL-2010
- Conditions
- Mild to Moderate Temporal Atrophy, Moderate to Severe Glabellar Rhytids, Moderate to Severe Periorbital Rhytids
- Keywords
- atrophy, rhytids, glabellar, periorbital
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beer, Kenneth R., M.D., PA
- Collaborators
- Medicis Pharmaceutical Corporation
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 May 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 support combination treatment of the upper face with Perlane-L® and Dysport™. This study will assess the outcome of upper face rejuvenation in the temporal fossa; outcome of glabella and/or periorbital regions will also be assessed as a secondary endpoint.
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: Dysport, Device: Perlane LDysport injections into the glabella and orbicularis oculi muscles with dose based on muscle mass |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Outpatient,male or female subjects of any race, 40-75 years of age.
- Mild to Moderate temoral atrophy of (1 or 2 on Four Point Temporal Atrophy Scale)
- One of the following:
- Periocular rhytids characterized by a measurement of 3 or more during maximum attempted muscle contraction (during maximum smiling) upon evaluation using the Rao-Goldman 5 point Facial Wrinkle Scale.
- Mild to moderate glabella rhytiuds by a measurment of 3 or more upon evaluation using the Rao-Goldman 5-point Facial Wrinkle Scale.
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 procerus and corrugator muscle mass. Muscle mass will be graded separately for males and females as +, ++, or+++ (light/small, moderate/medium, or heavy/large) by assessment of the procerus/corrugator muscles. Male patients will receive 0.3 mL to 0.4 mL (60, 70, or 80 units) in five equally divided doses of Dysport™ 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 Subjects will be treated with Dysport™ 20 or 30 units bilaterally to crow's feet. Subjects will be treated at baseline and if maximum amount of product has not been used at 1 month follow up subject will receive a touch up. No further treatment will be done for the remaining study visits. | Drug | Dysport |
| Perlane LThe subject will be allowed to receive up to 4 mls between the temporal fossa and the glabella area. | Device | Dysport |
Primary outcome
Upper face rejuvenation in the temporal fossa
Time frame: 9months
Subjects are assessed from a Four Point Temporal Atropy scale at baseline(must present with a 1 or 2 score).Subject will be assessed at 1 month with additonal treatment if needed and return at month 3,6, and 9 months and be assessed with the Four Point Atrophy Scale.
1 secondary outcome
Measure of rejuvenation in glabella and/or periorbital regions
Time frame: 9 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.
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 and Perlane L in people with Mild to Moderate Temporal Atrophy and Moderate to Severe Glabellar Rhytids, run by Beer, Kenneth R., M.D., PA 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?
Upper face rejuvenation in the temporal fossa (time frame: 9months). 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 26 Sep 2013.