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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 (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
History of Changes
  Purpose

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.


Condition Intervention Phase
Skin Aging
 Biological: Botulinum Toxin A
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Botox Skin Aging
U.S. FDA Resources

Further study details as provided by Biolab Sanus Farmaceutica:

Primary Outcome Measures:
  • 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.


Enrollment: 121
Study Start Date: September 2009
Study Completion Date: November 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xeomin®
Botulinum Toxin A
 Biological: Botulinum Toxin A
100 U DL50 lyophilized powder for reconstitution in 1 ml Saline Solution 0.9%.
Other Name: Xeomin®

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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986570

Locations
Brazil
Universidade Federal de São Paulo/Hospital São Paulo
São Paulo, Brazil, 04022-000
Sponsors and Collaborators
Biolab Sanus Farmaceutica
Investigators
Principal Investigator: Sergio Talarico, MD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Sérgio Talarico Filho, Univesidade Federal de São Paulo
ClinicalTrials.gov Identifier: NCT00986570     History of Changes
Other Study ID Numbers: XEO-001/07
Study First Received: September 29, 2009
Results First Received: November 17, 2010
Last Updated: December 7, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Biolab Sanus Farmaceutica:
Botulinum Toxin A
Wrinkles

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013