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This is an open-label and phase IV study of full face injections of variable doses of 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.
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.
220.127.116.11 Severity of wrinkles
One sub-investigator will rate the wrinkles with the following validated severity scales for the main areas of the face in relaxed mode and under maximal contraction, at visit 0, visits 2 (week 4) and 3 (week 16):
- Clinical 0-3 score for glabellar frown lines7 (Annex 4)
- Photonumeric Atlas for the Assessment of Crow's Feet Severity8 (Annex 5)
- Photonumerical Atlas for the Assessment of Forehead Wrinkle Severity9 (Annex 6)
- Marionette Lines Grading Scale10 (Annex 7)
18.104.22.168 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 Evaluation of Quality of Life and patient-reported complains, outcomes and satisfaction Patients will be invited to answer the WHOQoL bref (Annex 2). They will also answer a questionnaire regarding their believes, expectations and spontaneous complaints before and after treatment (Annex 3). This questionnaires will be answered by the patients in the visits: screening, 2, 3, 4 e 5. .
4.2.4 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®)
4.2.5 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 21G needle, giving a concentration of 250 Units/mL or 2.5Units/0.01mL 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 through BD Ultra-fine II 0.3cc syringes, with a 29G needle, 0.5cm in length (short needle).
Immediately after the application, the side effects will be verified and if needed, will be registered and managed.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Brazilian Center for Studies in Dermatology
Rio Grande do Sul
Active, not recruiting
Brazilan Center for Studies in Dermatology
Published on BioPortfolio: 2014-07-24T14:10:36-0400
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