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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00986570
Recruitment Status : Completed
First Posted : September 30, 2009
Results First Posted : December 6, 2010
Last Update Posted : December 11, 2015
Information provided by (Responsible Party):
Biolab Sanus Farmaceutica

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.

Condition or disease Intervention/treatment Phase
Skin Aging Biological: Botulinum Toxin A Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

Arm Intervention/treatment
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®

Primary Outcome Measures :
  1. Treatment Success [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00986570

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

Responsible Party: Biolab Sanus Farmaceutica Identifier: NCT00986570     History of Changes
Other Study ID Numbers: XEO-001/07
First Posted: September 30, 2009    Key Record Dates
Results First Posted: December 6, 2010
Last Update Posted: December 11, 2015
Last Verified: November 2015

Keywords provided by Biolab Sanus Farmaceutica:
Botulinum Toxin A

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents