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 (XEO-001/07)

This study has been completed.
Sponsor:
Information provided by:
Biolab Sanus Farmaceutica
ClinicalTrials.gov Identifier:
NCT00986570
First received: September 29, 2009
Last updated: December 7, 2010
Last verified: December 2010

September 29, 2009
December 7, 2010
September 2009
June 2010   (final data collection date for primary outcome measure)
Treatment Success [ Time Frame: Baseline (pre-treatment) and Visit 3 (Day 15) ] [ Designated as safety issue: No ]
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.
Success has been defined as the reduction of any grade to a lower grade of expression wrinkles. The wrinkles will be classified according to the following: absence, mild, moderate, severe. [ Time Frame: Visits 3 (Day 15) and 5 (Day 120) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00986570 on ClinicalTrials.gov Archive Site
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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
Phase III Open Label 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

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.

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.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Skin Aging
Biological: Botulinum Toxin A
100 U DL50 lyophilized powder for reconstitution in 1 ml Saline Solution 0.9%.
Other Name: Xeomin®
Experimental: Xeomin®
Botulinum Toxin A
Intervention: Biological: Botulinum Toxin A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
November 2010
June 2010   (final data collection date for primary outcome measure)

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.
Female
30 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00986570
XEO-001/07
No
Sérgio Talarico Filho, Univesidade Federal de São Paulo
Biolab Sanus Farmaceutica
Not Provided
Principal Investigator: Sergio Talarico, MD Federal University of São Paulo
Biolab Sanus Farmaceutica
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP