Wrinkles in Frontal AreaPhase 4NCT00989768
Field of Effects of Two Commercial Preparations of Botulinum Toxin Type A
A Phase 4 study testing Botulinum Toxin Type A (Dysport®), Botulinum Toxin Type A/Botox® and Botulinum Toxin Type A/Dysport® in people with Wrinkles in Frontal Area, run by Hexsel Dermatology Clinic at 1 site in Brazil.
Trial summary
The objective of this study is to compare the field of effects of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products… 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
- Wrinkles in Frontal Area
- What is being tested?
- Botulinum Toxin Type A (Dysport®), Botulinum Toxin Type A/Botox® and Botulinum Toxin Type A/Dysport®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBrazil
- Study dates
- May 2005to Dec 2007
- 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
- Written Informed Consent (Annex 1)
- Female
- Subjects agreeing to take part in all procedures of the study, including botulinum toxin applications, Minor's test, measurement of Evoked Potentials, photographs, etc.), after being fully informed on the objectives and nature of the investigations
- Subjects aged between 18 and 60 years
- Subjects presenting with moderate to severe wrinkles on the forehead under maximum voluntary contraction of the m. frontalis
- Subjects with positive Minor's test showing sweating on the forehead in standardized conditions described in Annex 2
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- The Minor's Test will be the last inclusion criterion to be evaluated. Only these patients eligible according to the other inclusion criteria will undergo the Minor's Test to evaluate their sweating on the forehead. The cut off point is a positive Minor's Test (Level +1) - only subjects with Minor's Test (Level +1) will be recruited in the study (Annex 2).
- Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the products under investigation
- Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using an effective contraceptive method;
- Availability of the patient throughout the duration of the study (112 days)
- Subject agrees not to undergo other cosmetic or dermatological procedures during the study
- Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol
Who cannot join
- Pregnant women or women intending to become pregnant in the next 4 months after screening for eligibility
- Subjects who are lactating
- Subjects having undergone botulinum toxin treatment within the last 6 months
- 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
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- Subjects presenting fronto-parietal alopecia according to the Norwood-Hamilton classification
- Subjects with neoplastic, muscular or neurological diseases
- Subjects using aminoglycoside and penicillamine antibiotics, quinine and 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 the formula, ptosis or any other adverse effect, which in the investigator's opinion should prevent the patient from participating in the study
- Subjects presenting myasthenia gravis, Eaton-Lambert Syndrome and motor neuron diseases
- Subjects with coagulation disorders or using anticoagulants
- Subjects with known systemic autoimmune diseases
- Subjects with a history of medical treatment non-adherence 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, 90570 040
About this study
Official title: Field Effects of Two Commercial Preparations of Botulinum Toxin Type a Administered to the Frontalis Muscles
The objective of this study is to compare the field of effects of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, trough scales and photographs evaluations.
Read the detailed description
This was a monocentric, prospective, randomized and double-blind study. Twenty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. Subjects have received botulinum toxin type-A injections in two forehead sites, Botox 2U and Dysport 5U, both reconstituted in the same volume of 0.02 mL per point. Baseline, twenty-eight and 112 days later, clinical and photographic assessments, Minor´s test, and electromyographic (EMG) evaluations were performed.
- Conditions
- Wrinkles in Frontal Area
- Being tested
- Botulinum Toxin Type A (Dysport®), Botulinum Toxin Type A/Botox®, Botulinum Toxin Type A/Dysport®
- Keywords
- Botulinum toxin type A, field effects, dose-equivalence, anhydrotic action halos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A (Dysport®)Drug
Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2,5:1. Both reconstituted in the same volume per point, injected in the forehead determined site.
-Dysport®: 5 units will be injected in the left or right forehead side.
Botulinum Toxin Type A/Botox®Drug
2 units will be injected in the left or right forehead side.(opposite side of dysport injection)
Botulinum Toxin Type A/Dysport®Drug
Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site.
-Dysport®: 4 units will be injected in the left or right forehead side, 2:1 ratio Dysport/Botox.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type - A | Experimental | Dysport® compared to Botox® Receives: Drug: Botulinum Toxin Type A (Dysport®); Drug: Botulinum Toxin Type A/Botox®; Drug: Botulinum Toxin Type A/Dysport® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal Action Halo Diameter at 28 Days
The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 28 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).
Measured: 28 Days
Horizontal Action Halo Diameter at 112 Days
The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 112 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).
Measured: 112 days
Secondary outcomes (2)
ECMAP in m. Frontialis
The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).
Measured: 28 days
ECMAP in m. Frontialis
The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).
Measured: 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startMay 2005
- Primary completionNov 2007
- Study completionDec 2007
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 Wrinkles in Frontal AreaStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hexsel Dermatology Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Doris M Hexsel, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989768
- Sponsor's protocol ID
- 01-CBED06b
- Status last verified
- Oct 2009
- First submitted
- 5 Oct 2009
- Last updated
- 2 Jun 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Effects of Two Commercial Preparations of Botulinum Toxin Type a Administered to the Frontalis Muscles
- ClinicalTrials.gov ID
- NCT00989768
- Acronym / sponsor ID
- 01-CBED06b
- Conditions
- Wrinkles in Frontal Area
- Keywords
- Botulinum toxin type A, field effects, dose-equivalence, anhydrotic action halos
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hexsel Dermatology ClinicUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Oct 2009 (estimated)
- Results
- Posted 27 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the field of effects of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, trough scales and photographs evaluations.
Detailed description
This was a monocentric, prospective, randomized and double-blind study. Twenty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. Subjects have received botulinum toxin type-A injections in two forehead sites, Botox 2U and Dysport 5U, both reconstituted in the same volume of 0.02 mL per point. Baseline, twenty-eight and 112 days later, clinical and photographic assessments, Minor´s test, and electromyographic (EMG) evaluations were performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin type - A | Experimental | Drug: Botulinum Toxin Type A (Dysport®), Drug: Botulinum Toxin Type A/Botox®, Drug: Botulinum Toxin Type A/Dysport®Dysport® compared to Botox® |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Written Informed Consent (Annex 1)
- Female
- Subjects agreeing to take part in all procedures of the study, including botulinum toxin applications, Minor's test, measurement of Evoked Potentials, photographs, etc.), after being fully informed on the objectives and nature of the investigations
- Subjects aged between 18 and 60 years
- Subjects presenting with moderate to severe wrinkles on the forehead under maximum voluntary contraction of the m. frontalis
Key exclusion criteria (17 listed)
- Pregnant women or women intending to become pregnant in the next 4 months after screening for eligibility
- Subjects who are lactating
- Subjects having undergone botulinum toxin treatment within the last 6 months
- Subjects participating in other clinical trials
- Any prior surgery affecting the frontalis and/or orbicularis muscles, prior blepharoplasty or brow lift
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 A (Dysport®)Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2,5:1. Both reconstituted in the same volume per point, injected in the forehead determined site. -Dysport®: 5 units will be injected in the left or right forehead side. | Drug | Botulinum toxin type - A |
| Botulinum Toxin Type A/Botox®2 units will be injected in the left or right forehead side.(opposite side of dysport injection) | Drug | Botulinum toxin type - A |
| Botulinum Toxin Type A/Dysport®Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site. -Dysport®: 4 units will be injected in the left or right forehead side, 2:1 ratio Dysport/Botox. | Drug | Botulinum toxin type - A |
Primary outcome
Horizontal Action Halo Diameter at 28 Days
Time frame: 28 Days
The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 28 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).
Horizontal Action Halo Diameter at 112 Days
Time frame: 112 days
The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 112 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).
2 secondary outcomes
ECMAP in m. Frontialis
Time frame: 28 days
ECMAP in m. Frontialis
Time frame: 112 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2010.
- 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 M Hexsel, MD principal investigator
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 Botulinum Toxin Type A (Dysport®), Botulinum Toxin Type A/Botox® and Botulinum Toxin Type A/Dysport® in people with Wrinkles in Frontal Area, 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 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 2 Jun 2010. 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 27 Apr 2010). 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?
Horizontal Action Halo Diameter at 28 Days (time frame: 28 Days). 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 2 Jun 2010.