Skin Aging
Conditions
Keywords
Botulinum Toxin A, Wrinkles
Brief summary
The purpose of this study is to determinate whether Xeomin® (Botulinum toxin Type A) is safe, effective and tolerable in woman aged 30 to 50 years old for treatment of mild, moderate or severe expression lines (wrinkles) in the upper third of the face. The main outcome was the change in appearance of the wrinkles two weeks (visit 3) after product application as compared with baseline assessment.
Detailed description
Ageing is a dynamic and unchangeable process involving all individuals and affecting the several organic systems. This process is expressed through multiple symptoms and signs, the wrinkles and flaccidity being the most common and visible ones. In both developed and emerging countries, the interest in skin ageing is, to a greater extent, the result of the progressive increase in the absolute number and the proportion of people experiencing the ageing process in the last century. The psychosocial, as well as the physiological effects of the skin ageing raised a huge demand for a better understanding of this process and, in particular, of the effective interventions. The use of the botulinum toxin type-A (BTX/A) for aesthetic indication emerged as a result of the clinical observation of those patients treated for facial different dystonia and who presented additional improvement of their expression lines. The expression lines are most easily noted on the upper third of the face, where surgical treatments are fully invasive and show lesser noticeable results. The upper third of the face was targeted for BTX/A treatment and reported in several scientific literature articles as well succeeded.
Interventions
BIOLOGICALBotulinum Toxin A
100 U DL50 lyophilized powder for reconstitution in 1 ml Saline Solution 0.9%.
Sponsors
Biolab Sanus Farmaceutica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 30 to 50 years old, inclusive. * Mild, moderate or severe expression wrinkles. * Patients who had understood and signed the Informed Consent Form.
Exclusion criteria
* Subjects treated with botulinum toxin on the upper third of the face within the previous 6-month period; * Former implantation of permanent material and surgery (scars). * Use of any anticoagulant agent up to 7 days prior to the investigational product application; * Concomitant use of aminoglycosides or of any other drug that may impair in the neuromuscular transmission; * Coagulopathies and local inflammation/ infection at the application site. * Diseases which do impact on the neuromuscular function, such as: myasthenia gravis, Eaton Lambert Syndrome; * Pregnancy or breast feeding, women with potential to become pregnant or who do not agree to use an effective contraception method (Pearl Index \< 1%); * Allergy or known sensitivity to any of the components of the investigational drug; * Subjects who were enrolled in other clinical trial for the last 12-month period prior to the present study, as per Resolution 251/97; * Subjects who disagree with the study procedures, who do not sign the Informed Consent Form or who are not committed to participate in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success | Baseline (pre-treatment) and Visit 3 (Day 15) | Success has been defined as the reduction of any grade to a lower grade of expression wrinkles in the visit 3 (day 15) compared to the baseline assessment. The wrinkles will be classified according to the following: absence, mild, moderate, severe. |
Countries
Brazil
Participant flow
Recruitment details
Date of recruitment : 01-Sep-2009 to 09-Feb-2010 Location: Outpatient clinic; Cosmiatry, surgery and oncology unit, Department of Dermatology, UNIFESP, Sao Paulo, Brazil
Participants by arm
| Arm | Count |
|---|---|
| Xeomin® Botulinum Toxin A in IM injections single dose as follows:
24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites) | 121 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Potential bias for objective assessment | 1 |
Baseline characteristics
| Characteristic | Xeomin® |
|---|---|
| Age, Continuous | 42.52 years STANDARD_DEVIATION 0.42 |
| Age, Customized Between 30 and 50 years | 121 participants |
| Region of Enrollment Brazil | 121 participants |
| Sex: Female, Male Female | 121 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 94 / 121 |
| serious Total, serious adverse events | 1 / 121 |
Outcome results
Primary
Treatment Success
Success has been defined as the reduction of any grade to a lower grade of expression wrinkles in the visit 3 (day 15) compared to the baseline assessment. The wrinkles will be classified according to the following: absence, mild, moderate, severe.
Time frame: Baseline (pre-treatment) and Visit 3 (Day 15)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Xeomin® | Treatment Success | 89.08 % of participants |