Sun-induced Wrinkles Clinical Trial
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01728337 -
Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum
|
Phase 4 |