Phase 3
N=121
Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face
Skin Aging
Bottom Line
View on ClinicalTrials.gov: NCT00986570 ↗Enrolled (actual)
121
Serious AEs
0.8%
Results posted
Dec 2010
Primary outcome: Primary: Treatment Success — 89.08 % of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botulinum Toxin A (Biological)
- Age
- Adult · 30+ yrs
- Sex
- Female
- Sponsor
- Biolab Sanus Farmaceutica
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success |
89.08 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00986570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.