Sun-induced WrinklesPhase 4NCT01728337
Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum
A Phase 4 study testing Dysport and Xeomin in people with Sun-induced Wrinkles, run by Hexsel Dermatology Clinic at 1 site in Brazil.
Trial summary
this study was proposed to provide more scientific and objective data on the clinical and aesthetic effects of these two toxins (Dysport and Xeomin). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sun-induced Wrinkles
- What is being tested?
- Dysport and Xeomin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2011to Feb 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol;
- Female subjects;
- Phototype I to IV;
- Subjects aged between 18 and 60 years;
- Subjects naive for BT-A treatment;
- Subjects presenting the same degree of moderate (2) to severe (3) wrinkles on the left and right side of forehead under maximum voluntary contraction of the frontalis m. according WSS;
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- Subjects with Minor's test showing at least grade III in the Sweating Intensity Visual Scale;
- Medical history and physical examination which, based on the investigator's opinion, do not prevent the subject from taking part in the study or from making use of the products under investigation;
- Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using a highly effective contraceptive method during all study;
- Availability of the subject throughout the study (5 months);
- Subject agreeing not to undergo other cosmetic or dermatological procedures during the participation in the study;
- Subjects with sufficient schooling and knowledge to enable them to cooperate to the degree required by the protocol.
Who cannot join
- Pregnant women or women intending to become pregnant in the following 5 months after screening;
- Lactation period;
- Subjects participating in other clinical trials;
- Any prior surgery affecting the frontalis and/or orbicularis muscles, prior blepharoplasty or brow lift;
- Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results;
- Subjects with neoplastic, muscular or neurological diseases;
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- Subjects taking aminoglycoside and penicillamine antibiotics, quinine or Ca2+ channel blockers;
- Subjects with inflammation or active infection in the area to be injected;
- Subjects presenting evident facial asymmetry;
- Subjects with a history of adverse effects, such as sensitivity to the components of any of the study drug formula, ptosis or any other adverse effect which, in the investigator's opinion, should prevent the subject from participating in the study;
- Subjects presenting Myasthenia Gravis, Eaton-Lambert Syndrome and motor neuron disease;
- Subjects with coagulation disorders or taking anticoagulants;
- Subjects with known systemic autoimmune diseases;
- Subjects with a history of non-adherence to medical treatment or showing unwillingness to adhere to the study protocol;
- Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Brazilian Center For Studies in Dermatology
Porto Alegre, Rio Grande do Sul
About this study
Official title: Phase IV, Randomized, Double-blind Study on Muscle Activity of Two Commercial Preparations of Botulinum Toxin Type A (Dysport and Xeomin) Administered to the Upper Third of the Face (Forehead Lines).
this study was proposed to provide more scientific and objective data on the clinical and aesthetic effects of these two toxins (Dysport and Xeomin).
Read the detailed description
Subjects will perform 6 (six) visits during the study:
Screening visit, performed 30 to 1 day before the visit 1, when eligible subjects will be recruited and first evaluations will be performed; visit 1, which is the baseline and when the injections will be performed; visit 2, 30 +/- 3 days after the injections, when evaluations will be performed; visit 3, 90 +/- 3 days after the injections, when evaluations will be performed; 4, 120 +/- 3 days after the injections, when evaluations will be performed; visit 5, 150 +/- 3 days after the injections, when evaluations will be performed.
Assessment of percentage (%) of responders, after 5 months of injection, to the effects of two BT-A preparations, Dysport® and Xeomin®, by measuring frontalis m. wrinkle intensity at maximum contraction, as measured by visual Wrinkles Severity Scale (WSS).
- Conditions
- Sun-induced Wrinkles
- Being tested
- Dysport, Xeomin
- Keywords
- botulinum toxin,, wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DysportDrug
Also called botulinum toxin type A
Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
XeominDrug
Also called botulinum toxin type A
Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead
| Study group | Role | What they receive |
|---|---|---|
| Dysport and Xeomin | Active comparator | 30 U of Dysport® was injected on the right side of the forehead and 12 U Xeomin® was injected on the left side of the forehead (dose-equivalence 2.5:1). Receives: Drug: Dysport; Drug: Xeomin |
| Xeomin and Dysport | Active comparator | 30 U Dysport® was injected on the left side of the forehead and 12 U Xeomin® was injected on the right side of the forehead (dose-equivalence 2.5:1). Receives: Drug: Dysport; Drug: Xeomin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Responders After 5 Months After the Procedure
Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score (WSS) at maximum contraction compared to the WSS score at baseline.
WSS is a validated 4-point scale, at rest and at maximum voluntary contraction of the frontalis muscle, in which 0 means no wrinkles up to 3 which means sever wrinkles.
Measured: 5 months after intervention
Secondary outcomes (1)
Maximum Evoked Compound Muscle Action Potential
To evaluate the duration, magnitude and peak of effects of two BT-A preparations, by measuring of the maximum Evoked Compound Muscle Action Potentials after contraction.
Measured: 5 months after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2012 (estimated)
- Study startJul 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sun-induced WrinklesStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hexsel Dermatology Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doris Hexsel, Hexsel Dermatology Clinic
- Investigators
- Doris Hexsel, MD, Principal investigator, Brazilian Center for Dermatologic Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728337
- Sponsor's protocol ID
- 12-2012
- Status last verified
- Jul 2019
- First submitted
- 7 Nov 2012
- Last updated
- 26 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Randomized, Double-blind Study on Muscle Activity of Two Commercial Preparations of Botulinum Toxin Type A (Dysport and Xeomin) Administered to the Upper Third of the Face (Forehead Lines).
- ClinicalTrials.gov ID
- NCT01728337
- Acronym / sponsor ID
- 12-2012
- Conditions
- Sun-induced Wrinkles
- Keywords
- botulinum toxin,, wrinkles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hexsel Dermatology ClinicUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Nov 2012 (estimated)
- Results
- Posted 11 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study was proposed to provide more scientific and objective data on the clinical and aesthetic effects of these two toxins (Dysport and Xeomin).
Detailed description
Subjects will perform 6 (six) visits during the study:
Screening visit, performed 30 to 1 day before the visit 1, when eligible subjects will be recruited and first evaluations will be performed; visit 1, which is the baseline and when the injections will be performed; visit 2, 30 +/- 3 days after the injections, when evaluations will be performed; visit 3, 90 +/- 3 days after the injections, when evaluations will be performed; 4, 120 +/- 3 days after the injections, when evaluations will be performed; visit 5, 150 +/- 3 days after the injections, when evaluations will be performed.
Assessment of percentage (%) of responders, after 5 months of injection, to the effects of two BT-A preparations, Dysport® and Xeomin®, by measuring frontalis m. wrinkle intensity at maximum contraction, as measured by visual Wrinkles Severity Scale (WSS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dysport and Xeomin | Active comparator | Drug: Dysport, Drug: Xeomin30 U of Dysport® was injected on the right side of the forehead and 12 U Xeomin® was injected on the left side of the forehead (dose-equivalence 2.5:1). |
| Xeomin and Dysport | Active comparator | Drug: Dysport, Drug: Xeomin30 U Dysport® was injected on the left side of the forehead and 12 U Xeomin® was injected on the right side of the forehead (dose-equivalence 2.5:1). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subject agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol;
- Female subjects;
- Phototype I to IV;
- Subjects aged between 18 and 60 years;
- Subjects naive for BT-A treatment;
Key exclusion criteria (15 listed)
- Pregnant women or women intending to become pregnant in the following 5 months after screening;
- Lactation period;
- Subjects participating in other clinical trials;
- Any prior surgery affecting the frontalis and/or orbicularis muscles, prior blepharoplasty or brow lift;
- Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results;
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 |
|---|---|---|
| DysportAlso: botulinum toxin type ADysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead. | Drug | Dysport and Xeomin, Xeomin and Dysport |
| XeominAlso: botulinum toxin type AXeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead | Drug | Dysport and Xeomin, Xeomin and Dysport |
Primary outcome
Percentage of Responders After 5 Months After the Procedure
Time frame: 5 months after intervention
Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score (WSS) at maximum contraction compared to the WSS score at baseline. WSS is a validated 4-point scale, at rest and at maximum voluntary contraction of the frontalis muscle, in which 0 means no wrinkles up to 3 which means sever wrinkles.
1 secondary outcome
Maximum Evoked Compound Muscle Action Potential
Time frame: 5 months after the procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Doris Hexsel, MD principal investigator
Brazilian Center for Dermatologic Studies
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 Xeomin in people with Sun-induced Wrinkles, run by Hexsel Dermatology Clinic at 1 site in Brazil.
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 12 inclusion and 15 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 Jul 2019. 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 Brazil. 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?
Yes. Results are posted in the registry (first posted 11 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Responders After 5 Months After the Procedure (time frame: 5 months after intervention). 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 Jul 2019.