Sun-induced WrinklesPhase 4NCT01032954
Safety and Efficacy of the Full Face Applications of Variable Doses of a Commercial Botulinum Toxin Type a (Dysport®)
A Phase 4 study testing Botulinum toxin in people with Sun-induced Wrinkles, run by Hexsel Dermatology Clinic at 1 site in Brazil.
Trial summary
This is an open-label and phase IV study of full face injections of variable doses of botulinum toxin type A (BT-A). As it is an open-label and not blind study, both investigator and subjects will know the injection local and doses of the study drug. Patients will be randomized into 3 different groups. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sun-induced Wrinkles
- What is being tested?
- Botulinum toxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2009to Dec 2010
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written Informed Consent;
- Subjects aged between 30 and 60 years;
- Skin Fitzpatrick Phototypes I to VI;
- Subjects that never received BT-A or who had previous injections of BT-A in no more than one third of the face with in the last 6 months;
- Subjects presenting at least two indications for treatment with BT-A in each third of the face;
- 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 product under investigation;
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- Subjects of childbearing age should present a negative urine pregnancy test (instant test) at baseline and should be using an effective contraceptive method (oral or injectable contraceptive, for at last three months, and use of preservative; subjects with: hysterectomy, oophorectomy or tubal ligation);
- Availability of the patient throughout the duration of the study (24 weeks);
- Subjects that agree 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 the study protocol.
Who cannot join
- Pregnant women or women intending to become pregnant during the study;
- Subjects participating in other clinical trials;
- Presence of scars on the face that may interfere with the result of study;
- Subjects with neoplastic, muscular or neurological diseases;
- Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics.
- Subjects with inflammation or active infection in the face;
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- Subjects with a history of sensitivity to the components of the formula;
- Subjects with prior history of eyelid ptosis; marked facial asymmetry, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.
- 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 clinically diagnosed anxiety disorder or any significant psychiatric disorder (e.g. depression) that, in the opinion of the Evaluator, might interfere with the Subject's participation in the study;
- Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol.
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: Phase Iv Study On The Safety And Efficacy Of The Full Face Applications Of Variable Doses Of 125 To 250 Units Of A Commercial Botulinum Toxin Type A (Dysport®)
This is an open-label and phase IV study of full face injections of variable doses of botulinum toxin type A (BT-A). As it is an open-label and not blind study, both investigator and subjects will know the injection local and doses of the study drug. Patients will be randomized into 3 different groups. Each group will receive a specific dose according with the indication evaluated by the investigator. Six visits will be schedule in this study.
Read the detailed description
4.2 Methodology
4.2.1 Patient evaluation After providing written informed consent, subject's eligibility will be assessed at a Screening Visit. The subject's general medical history will be recorded. This includes demographic data, history of surgical and cosmetic procedures, dermatological assessment, physical examination, and prior concomitant medications. A pregnancy test will also be performed.
4.2.1.1 Severity of wrinkles
One sub-investigator will rate the wrinkles with the following validated severity scales for the main areas of the face at Baseline, Week 4, Week 8, Week 16 and Week 24:
- Clinical 0-3 score for standardized assessment of facial wrinkles in the glabella area (from GLADYS study)
- Photometric Atlas for the Assessment of Crow's Feet Severity
- Facial Wrinkle Scale, for forehead lines (Carruthers A, et al. Dermatol Surg. 2003;29(5):461-7)
4.2.1.2 Standard set of photographs will be taken
At Screening , 2, 3, 4 and 5 visits, photographs will be taken:
All the photographs will be taken in a standardized photographic mode with fixed position of the camera. A guideline with examples of standardized photos with delimit standardized positions will be provided to the person responsible to take the photos.
In the photographs, each research subject will be identified by a tag containing a reference to the study, the number of the research subject and the control date. The research subjects should wash their faces before the photographic procedure to remove excess oil and all make up will be removed. All the pictures will be taken at the same room and under same parameters.
The photograph set consist of
- Full face frontal view relaxed;
- One set of photographs relaxed and contracted of each indication that patient will be or was treated in this study.
At the end of the study, two independent evaluators (dermatologists) will assess before and after pictures in a blinded manner. This evaluation will be done to assess the efficacy of BT-A in the injected areas not assessed by the scales.
4.2.3 Groups of treatment
Subjects will be assigned to one of the three following treatment groups, according with the total dose received in visit 1:
- Group 1: 30 subjects who received 125 to 170 U of BT-A (Dysport®)
- Group 2: 30 subjects who received 171 to 210 U of BT-A (Dysport®)
- Group 3: 30 subjects who received 211 to 250 U of BT-A (Dysport®)
4.2.4 Reconstitution of the study product and Treatment Administration An independent, experienced and registered pharmacist will be the assigned to carry through the reconstitution of the products. She will prepare the dilutions and the syringes of the product (DYSPORT®) immediately prior to the injections.
The dilutions of DYSPORT® 500 units per vial will be made with 2 mL of 0.9% sterile saline, using 3 mL syringes and a 21 gauge needle, giving a concentration of 250 units/mL or 2.5 units/0.01 mL of the reconstituted product.
An experienced dermatologist in the use of botulinum toxins (principal investigator - DH) will perform all the injections according to the indications and total number of units that will be injected according to the treatment plan, which aims to obtain the best results. She will only perform the injections and will not participate in other phases of this study.
The application of the BT-A will be made with Becton, Dickinson and Company (BD) Ultra-fine II 0.3 cc syringes, with a 29 gauge needle, 0.5 cm in length (short needle).
Immediately after the application, the side effects will be verified and if needed, will be registered and managed.
- Conditions
- Sun-induced Wrinkles
- Being tested
- Botulinum toxin
- Keywords
- Botulinum Toxin, Rejuvenation, Facial dynamic wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxinDrug
Also called Dysport
Drug: Botulinum toxin
Indications for eligibility and total doses that will be applied in each part of the face, at visit 1:
Upper face:
- Crow's feet wrinkles - 70 units
- Glabella - 50 units
- Forehead - 40 units
Mid face:
- Lower eyelid - 5 units
- Nasal wrinkles - 20 units
- Malar wrinkles - 10 units
Lower face:
- Peri-oral wrinkles - 15 units
- Asymmetric smile or gummy smile - 5 units
- "Cellulitic chin" - 20 units
- Marionette lines - 25 U According to the patients needs, the doses can vary ±10% in terms of the amount of units that will be injected.
Patients will be allocated in each group and receive the doses described above at visit 1. At visit 2, all the patients will receive a touch-up of a standard dose of 25 U, distributed on the treated areas according patient's needs.
| Study group | Role | What they receive |
|---|---|---|
| 125 to 170 IU of "'Botulinum toxin' " | Active comparator | group with intervention of 125 to 170 IU of 'Botulinum toxin' Receives: Drug: Botulinum toxin |
| 171 to 210 IU of 'Botulinum toxin' | Active comparator | Patients who have received 171 to 210 IU of 'Botulinum toxin' Receives: Drug: Botulinum toxin |
| 211 to 250 IU of Botulinum toxin | Active comparator | Patients who have received 211 to 250 U of Botulinum toxi' Receives: Drug: Botulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkles' Severity (Forehead)
Facial Wrinkle Scale: 0 - none, 1 - mild; 2 - moderate; 3 - severe
Measured: Baseline; Week 4; Week 16; Week 20; Week 24
Wrinkles' Severity (Glabella)
GLADYS study Atlas: 0 - no wrinkles, 1 - mild wrinkles; 2 - moderate wrinkles; 3 - severe wrinkles
Measured: Baseline; Week 4; Week 16; Week 20; Week 24
Wrinkles' Severity (Periocular [Crow's Feet])
Photonumeric Atlas for the Assessment of Crow's Feet Severity: 0 - none, 1 - mild; 2 - moderate; 3 - severe
Measured: Baseline; Week 4; Week 16; Week 20; Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionDec 2010
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
- None (open label)
- Enrolment
- 90 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 M Hexsel, MD, Principal investigator, Brazilian Center for Studies in Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032954
- Sponsor's protocol ID
- 01-CBED09-02
- Status last verified
- Sep 2020
- First submitted
- 15 Dec 2009
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Iv Study On The Safety And Efficacy Of The Full Face Applications Of Variable Doses Of 125 To 250 Units Of A Commercial Botulinum Toxin Type A (Dysport®)
- ClinicalTrials.gov ID
- NCT01032954
- Acronym / sponsor ID
- 01-CBED09-02
- Conditions
- Sun-induced Wrinkles
- Keywords
- Botulinum Toxin, Rejuvenation, Facial dynamic wrinkles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hexsel Dermatology ClinicUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Posted 17 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label and phase IV study of full face injections of variable doses of botulinum toxin type A (BT-A). As it is an open-label and not blind study, both investigator and subjects will know the injection local and doses of the study drug. Patients will be randomized into 3 different groups. Each group will receive a specific dose according with the indication evaluated by the investigator. Six visits will be schedule in this study.
Detailed description
4.2 Methodology
4.2.1 Patient evaluation After providing written informed consent, subject's eligibility will be assessed at a Screening Visit. The subject's general medical history will be recorded. This includes demographic data, history of surgical and cosmetic procedures, dermatological assessment, physical examination, and prior concomitant medications. A pregnancy test will also be performed.
4.2.1.1 Severity of wrinkles
One sub-investigator will rate the wrinkles with the following validated severity scales for the main areas of the face at Baseline, Week 4, Week 8, Week 16 and Week 24:
- Clinical 0-3 score for standardized assessment of facial wrinkles in the glabella area (from GLADYS study)
- Photometric Atlas for the Assessment of Crow's Feet Severity
- Facial Wrinkle Scale, for forehead lines (Carruthers A, et al. Dermatol Surg. 2003;29(5):461-7)
4.2.1.2 Standard set of photographs will be taken
At Screening , 2, 3, 4 and 5 visits, photographs will be taken:
All the photographs will be taken in a standardized photographic mode with fixed position of the camera. A guideline with examples of standardized photos with delimit standardized positions will be provided to the person responsible to take the photos.
In the photographs, each research subject will be identified by a tag containing a reference to the study, the number of the research subject and the control date. The research subjects should wash their faces before the photographic procedure to remove excess oil and all make up will be removed. All the pictures will be taken at the same room and under same parameters.
The photograph set consist of
- Full face frontal view relaxed;
- One set of photographs relaxed and contracted of each indication that patient will be or was treated in this study.
At the end of the study, two independent evaluators (dermatologists) will assess before and after pictures in a blinded manner. This evaluation will be done to assess the efficacy of BT-A in the injected areas not assessed by the scales.
4.2.3 Groups of treatment
Subjects will be assigned to one of the three following treatment groups, according with the total dose received in visit 1:
- Group 1: 30 subjects who received 125 to 170 U of BT-A (Dysport®)
- Group 2: 30 subjects who received 171 to 210 U of BT-A (Dysport®)
- Group 3: 30 subjects who received 211 to 250 U of BT-A (Dysport®)
4.2.4 Reconstitution of the study product and Treatment Administration An independent, experienced and registered pharmacist will be the assigned to carry through the reconstitution of the products. She will prepare the dilutions and the syringes of the product (DYSPORT®) immediately prior to the injections.
The dilutions of DYSPORT® 500 units per vial will be made with 2 mL of 0.9% sterile saline, using 3 mL syringes and a 21 gauge needle, giving a concentration of 250 units/mL or 2.5 units/0.01 mL of the reconstituted product.
An experienced dermatologist in the use of botulinum toxins (principal investigator - DH) will perform all the injections according to the indications and total number of units that will be injected according to the treatment plan, which aims to obtain the best results. She will only perform the injections and will not participate in other phases of this study.
The application of the BT-A will be made with Becton, Dickinson and Company (BD) Ultra-fine II 0.3 cc syringes, with a 29 gauge needle, 0.5 cm in length (short needle).
Immediately after the application, the side effects will be verified and if needed, will be registered and managed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 125 to 170 IU of "'Botulinum toxin' " | Active comparator | Drug: Botulinum toxingroup with intervention of 125 to 170 IU of 'Botulinum toxin' |
| 171 to 210 IU of 'Botulinum toxin' | Active comparator | Drug: Botulinum toxinPatients who have received 171 to 210 IU of 'Botulinum toxin' |
| 211 to 250 IU of Botulinum toxin | Active comparator | Drug: Botulinum toxinPatients who have received 211 to 250 U of Botulinum toxi' |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Written Informed Consent;
- Subjects aged between 30 and 60 years;
- Skin Fitzpatrick Phototypes I to VI;
- Subjects that never received BT-A or who had previous injections of BT-A in no more than one third of the face with in the last 6 months;
- Subjects presenting at least two indications for treatment with BT-A in each third of the face;
Key exclusion criteria (13 listed)
- Pregnant women or women intending to become pregnant during the study;
- Subjects participating in other clinical trials;
- Presence of scars on the face that may interfere with the result of study;
- Subjects with neoplastic, muscular or neurological diseases;
- Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics.
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 toxinAlso: DysportDrug: Botulinum toxin Indications for eligibility and total doses that will be applied in each part of the face, at visit 1: Upper face: * Crow's feet wrinkles - 70 units * Glabella - 50 units * Forehead - 40 units Mid face: * Lower eyelid - 5 units * Nasal wrinkles - 20 units * Malar wrinkles - 10 units Lower face: * Peri-oral wrinkles - 15 units * Asymmetric smile or gummy smile - 5 units * "Cellulitic chin" - 20 units * Marionette lines - 25 U According to the patients needs, the doses can vary ±10% in terms of the amount of units that will be injected. Patients will be allocated in each group and receive the doses described above at visit 1. At visit 2, all the patients will receive a touch-up of a standard dose of 25 U, distributed on the treated areas according patient's needs. | Drug | 125 to 170 IU of "'Botulinum toxin' ", 171 to 210 IU of 'Botulinum toxin', 211 to 250 IU of Botulinum toxin |
Primary outcome
Wrinkles' Severity (Forehead)
Time frame: Baseline; Week 4; Week 16; Week 20; Week 24
Facial Wrinkle Scale: 0 - none, 1 - mild; 2 - moderate; 3 - severe
Wrinkles' Severity (Glabella)
Time frame: Baseline; Week 4; Week 16; Week 20; Week 24
GLADYS study Atlas: 0 - no wrinkles, 1 - mild wrinkles; 2 - moderate wrinkles; 3 - severe wrinkles
Wrinkles' Severity (Periocular [Crow's Feet])
Time frame: Baseline; Week 4; Week 16; Week 20; Week 24
Photonumeric Atlas for the Assessment of Crow's Feet Severity: 0 - none, 1 - mild; 2 - moderate; 3 - severe
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- 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
Brazilian Center for Studies in Dermatology
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 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 10 inclusion and 13 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 14 Oct 2020. 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 17 Sep 2020). 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?
Wrinkles' Severity (Forehead) (time frame: Baseline; Week 4; Week 16; Week 20; Week 24). The study lists 3 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 14 Oct 2020.